Trial Outcomes & Findings for A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function (NCT NCT02443155)

Last Updated: 2021-04-09

Results Overview

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles\*hour per liter (nmol\*h/L).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

308 participants

Primary outcome timeframe

0 - 4 hours post-dose on week 0 and week 54

Results posted on

2021-04-09

Participant Flow

The trial was conducted at 94 sites in Austria, Belgium, Canada, Denmark, Finland, Ireland, Israel, Italy, Norway, Poland, Portugal, Russian Federation, Spain, Sweden, Ukraine, the United Kingdom (UK), and the United States (US).

Participants were randomised in a 1:1:1:1 manner to one of the four treatment groups. One participant was randomised to liraglutide arm but was withdrawn from the trial before exposure to trial products as per investigator's decision.

Participant milestones

Participant milestones
Measure	NNC0114-0006 + Liraglutide (Experimental) Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Overall Study STARTED	77	77	76	77
Overall Study Full Analysis Set	77	77	76	77
Overall Study PK Analysis Set	21	21	22	20
Overall Study Safety Analysis Set	77	77	76	77
Overall Study COMPLETED	65	63	67	61
Overall Study NOT COMPLETED	12	14	9	16

Reasons for withdrawal

Reasons for withdrawal
Measure	NNC0114-0006 + Liraglutide (Experimental) Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Overall Study Adverse Event	3	4	1	2
Overall Study Unclassified	0	0	2	1
Overall Study Withdrawal by Subject	4	7	3	9
Overall Study Pregnancy	3	1	1	2
Overall Study Lost to Follow-up	1	2	0	1
Overall Study Protocol Violation	1	0	1	1
Overall Study Death	0	0	1	0

Baseline Characteristics

A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Total n=307 Participants Total of all reporting groups
Age, Continuous	28.0 years STANDARD_DEVIATION 7.5 • n=5 Participants	28.6 years STANDARD_DEVIATION 7.9 • n=7 Participants	28.0 years STANDARD_DEVIATION 7.1 • n=5 Participants	29.0 years STANDARD_DEVIATION 7.0 • n=4 Participants	28.4 years STANDARD_DEVIATION 7.3 • n=21 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	32 Participants n=7 Participants	25 Participants n=5 Participants	28 Participants n=4 Participants	106 Participants n=21 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	45 Participants n=7 Participants	51 Participants n=5 Participants	49 Participants n=4 Participants	201 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants	74 Participants n=7 Participants	74 Participants n=5 Participants	76 Participants n=4 Participants	297 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants	70 Participants n=7 Participants	73 Participants n=5 Participants	76 Participants n=4 Participants	292 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants

PRIMARY outcome

Timeframe: 0 - 4 hours post-dose on week 0 and week 54

Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=66 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=65 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=68 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=63 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline	0.934 Ratio of AUC Geometric Coefficient of Variation 61.9	0.783 Ratio of AUC Geometric Coefficient of Variation 45.5	0.709 Ratio of AUC Geometric Coefficient of Variation 104.8	0.660 Ratio of AUC Geometric Coefficient of Variation 86.3

SECONDARY outcome

Timeframe: 0-2 hours post-dose on week 0 and week 54

Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol\*h/L'.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=66 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=65 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=68 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=63 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
AUC0-2h of C-peptide at Week 54 Relative to Baseline	0.961 Ratio of AUC Geometric Coefficient of Variation 65.4	0.824 Ratio of AUC Geometric Coefficient of Variation 53.0	0.646 Ratio of AUC Geometric Coefficient of Variation 97.4	0.655 Ratio of AUC Geometric Coefficient of Variation 87.3

SECONDARY outcome

Timeframe: 0-4 hours post-dose on week 0 and week 54

Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=66 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=65 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=68 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=63 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Cmax of C-peptide at Week 54 Relative to Baseline	0.978 Ratio of Cmax Geometric Coefficient of Variation 70.3	0.779 Ratio of Cmax Geometric Coefficient of Variation 47.6	0.733 Ratio of Cmax Geometric Coefficient of Variation 110.4	0.644 Ratio of Cmax Geometric Coefficient of Variation 89.4

SECONDARY outcome

Timeframe: 0 - 4 hours post-dose on week 0 and week 54

Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose was measured as Milli moles\*hour per liter (mmol\*h/L).

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=65 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=65 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=67 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=62 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
AUC0-4h of Glucose at Week 54 Relative to Baseline	0.904 Ratio of AUC Geometric Coefficient of Variation 33.1	1.078 Ratio of AUC Geometric Coefficient of Variation 31.8	0.993 Ratio of AUC Geometric Coefficient of Variation 34.2	1.089 Ratio of AUC Geometric Coefficient of Variation 36.7

SECONDARY outcome

Timeframe: 0-2 hours post-dose on week 0 and week 54

Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. AUC of glucose is measured as 'mmol\*h/L'.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=65 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=65 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=67 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=62 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
AUC0-2h of Glucose at Week 54 Relative to Baseline	0.939 Ratio of AUC Geometric Coefficient of Variation 28.5	1.066 Ratio of AUC Geometric Coefficient of Variation 24.8	0.978 Ratio of AUC Geometric Coefficient of Variation 31.9	1.057 Ratio of AUC Geometric Coefficient of Variation 31.3

SECONDARY outcome

Timeframe: 0-4 hours post-dose on week 0 and week 54

Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 54 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=65 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=65 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=67 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=62 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Cmax of Glucose at Week 54 Relative to Baseline	0.937 Ratio of Cmax Geometric Coefficient of Variation 27.8	1.068 Ratio of Cmax Geometric Coefficient of Variation 25.4	1.004 Ratio of Cmax Geometric Coefficient of Variation 29.1	1.057 Ratio of Cmax Geometric Coefficient of Variation 30.9

SECONDARY outcome

Timeframe: Week 0-54; Week 54-80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

An adverse event was any untoward medical occurrence in a participants administered a product, and which did not necessarily have a causal relationship with this treatment. An adverse event was defined as treatment emergent if the onset of the adverse event occurs on or after the first day of trial product administration. Number of treatment emergent adverse events from first dose of trial product to week 54 and week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Number of Treatment Emergent Adverse Events Week 0-54	434 Adverse events	327 Adverse events	410 Adverse events	364 Adverse events
Number of Treatment Emergent Adverse Events Week 54-80	70 Adverse events	73 Adverse events	78 Adverse events	87 Adverse events

SECONDARY outcome

Timeframe: Week 0-54; Week 54-80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Hyperglycaemic episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Number of Treatment Emergent Hyperglycaemic Episodes Week 0-54	302 Episodes	256 Episodes	217 Episodes	291 Episodes
Number of Treatment Emergent Hyperglycaemic Episodes Week 54-80	306 Episodes	74 Episodes	352 Episodes	112 Episodes

SECONDARY outcome

Timeframe: Weeks 0-54; Weeks 54-80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Diabetic ketoacidosis episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of treatment emergent episodes of hyperglycaemic episodes from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results are based on the on-treatment and on-observation period. On-treatment period: From the day of first trial product administration to the day of the visit at week 54. On-observation: From the day after the visit at week 54 to the day of the last visit.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Number of Treatment Emergent Episodes of Diabetic Ketoacidosis Week 0-54	0 Episodes	0 Episodes	0 Episodes	0 Episodes
Number of Treatment Emergent Episodes of Diabetic Ketoacidosis Week 54-80	0 Episodes	0 Episodes	1 Episodes	1 Episodes

SECONDARY outcome

Timeframe: Week 0-54

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Injection/infusion site reactions episodes were defined as treatment-emergent if the onset occurred on or after the first day of trial product administration. Number of participants experiencing treatment emergent episodes of injection/infusion site reactions episodes from first dose of trial product to week 54 (treatment period) is presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/Infusion	2 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Weeks 0-54; Weeks 54-80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 1 day after the date of last contact. Number of treatment-emergent hypoglycaemic episodes according to American Diabetes Association (ADA) classification from first dose of trial product to week 54 and from week 54 to week 80 are presented. Results presented hypoglycaemia episodes were recorded as per ADA definition: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Pseudo-hypoglycaemia.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Asymptomatic hypoglycaemia (Week 54-80)	609 Episodes	522 Episodes	670 Episodes	449 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Documented symptomatic hypoglycaemia (Week 54-80)	514 Episodes	362 Episodes	651 Episodes	527 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Pseudo-hypoglycaemia (Week 54-80)	0 Episodes	0 Episodes	1 Episodes	2 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Probable symptomatic hypoglycaemia (Week 54-80)	1 Episodes	0 Episodes	0 Episodes	2 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Severe hypoglycaemia (Week 0-54)	1 Episodes	2 Episodes	0 Episodes	0 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Asymptomatic hypoglycaemia (Week 0-54)	2038 Episodes	1956 Episodes	2092 Episodes	1774 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Documented symptomatic hypoglycaemia (Week 0-54)	1305 Episodes	1461 Episodes	1114 Episodes	1625 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Pseudo-hypoglycaemia (Week 0-54)	1 Episodes	1 Episodes	14 Episodes	2 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Probable symptomatic hypoglycaemia (Week 0-54)	9 Episodes	0 Episodes	4 Episodes	10 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Severe hypoglycaemia (Week 54-80)	3 Episodes	1 Episodes	0 Episodes	1 Episodes

SECONDARY outcome

Timeframe: Weeks 0-54; Weeks 54-80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value \<3.1 mmol/L without symptoms consistent with hypoglycaemia. Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. BG-confirmed: An episode that is BG-confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Severe or BG-confirmed: An episode that is severe according to the International Society for Pediatric and Adolescent Diabetes (ISPAD) classification or BG-confirmed by a PG value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions Severe or BG confirmed (Week 0-54)	396 Episodes	394 Episodes	315 Episodes	503 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions Symptomatic BG confirmed (Week 0-54)	576 Episodes	616 Episodes	479 Episodes	646 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions Severe or BG confirmed (Week 54-80)	216 Episodes	130 Episodes	244 Episodes	240 Episodes
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk Definitions Symptomatic BG confirmed (Week 54-80)	368 Episodes	207 Episodes	332 Episodes	292 Episodes

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Overall number of participants analyzed = participants with available data.

Change in body weight is measured at week 54 and week 80 respective to baseline. Body weight was measured in unit 'Kg'.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Body Weight (kg) Change from week 0 to week 54	-1.8 Kilogram (Kg) Standard Deviation 4.2	1.2 Kilogram (Kg) Standard Deviation 5.0	-2.5 Kilogram (Kg) Standard Deviation 4.0	1.1 Kilogram (Kg) Standard Deviation 6.1
Change in Body Weight (kg) Change from week 0 to week 80	1.9 Kilogram (Kg) Standard Deviation 4.6	1.6 Kilogram (Kg) Standard Deviation 5.2	0.4 Kilogram (Kg) Standard Deviation 4.7	2.8 Kilogram (Kg) Standard Deviation 5.5

SECONDARY outcome

Timeframe: Baseline, week 54 and week 80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Number of participants evaluated for diabetic retinopathy at baseline (Day -28 to -14), week 54 and week 80 are presented as 'yes', 'no' or 'unknown'.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Diabetes Retinopathy Baseline (Day:-28 to -14) · Yes	4 Participants	2 Participants	1 Participants	1 Participants
Diabetes Retinopathy Baseline (Day:-28 to -14) · No	73 Participants	75 Participants	75 Participants	76 Participants
Diabetes Retinopathy Baseline (Day:-28 to -14) · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Diabetes Retinopathy Week 54 · Yes	3 Participants	2 Participants	1 Participants	0 Participants
Diabetes Retinopathy Week 54 · No	65 Participants	63 Participants	68 Participants	68 Participants
Diabetes Retinopathy Week 54 · Unknown	0 Participants	0 Participants	0 Participants	0 Participants
Diabetes Retinopathy Week 80 · Yes	3 Participants	2 Participants	1 Participants	0 Participants
Diabetes Retinopathy Week 80 · No	65 Participants	62 Participants	67 Participants	63 Participants
Diabetes Retinopathy Week 80 · Unknown	1 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

The eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change in eGFR (measured in milliliters per minute per 1.73 square meters) from baseline (week 0) at week 54 and week 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline Change from week 0 to week 54	0.98 Ratio of eGFR Geometric Coefficient of Variation 10.3	0.95 Ratio of eGFR Geometric Coefficient of Variation 8.2	0.97 Ratio of eGFR Geometric Coefficient of Variation 10.2	1.00 Ratio of eGFR Geometric Coefficient of Variation 8.8
Estimated Glomerular Filtration Rate (eGFR)- Ratio to Baseline Change from week 0 to week 80	0.97 Ratio of eGFR Geometric Coefficient of Variation 9.3	0.94 Ratio of eGFR Geometric Coefficient of Variation 11.4	0.96 Ratio of eGFR Geometric Coefficient of Variation 11.5	0.99 Ratio of eGFR Geometric Coefficient of Variation 10.9

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in erythrocytes (measured in 10\^12 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Erythrocytes Change from week 0 to week 54	0.99 ratio of erythrocytes Geometric Coefficient of Variation 6.00	1.01 ratio of erythrocytes Geometric Coefficient of Variation 6.3	0.99 ratio of erythrocytes Geometric Coefficient of Variation 7.2	1.00 ratio of erythrocytes Geometric Coefficient of Variation 6.0
Change in Haematology: Erythrocytes Change from week 0 to week 80	0.99 ratio of erythrocytes Geometric Coefficient of Variation 6.7	1.00 ratio of erythrocytes Geometric Coefficient of Variation 6.7	0.99 ratio of erythrocytes Geometric Coefficient of Variation 7.00	1.00 ratio of erythrocytes Geometric Coefficient of Variation 5.5

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in haematocrit (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Haematocrit Change from week 0 to week 54	0.99 ratio of haematocrit Geometric Coefficient of Variation 6.6	1.00 ratio of haematocrit Geometric Coefficient of Variation 7.00	0.99 ratio of haematocrit Geometric Coefficient of Variation 7.8	1.00 ratio of haematocrit Geometric Coefficient of Variation 5.9
Change in Haematology: Haematocrit Change from week 0 to week 80	0.98 ratio of haematocrit Geometric Coefficient of Variation 7.5	1.00 ratio of haematocrit Geometric Coefficient of Variation 7.3	0.98 ratio of haematocrit Geometric Coefficient of Variation 7.2	0.99 ratio of haematocrit Geometric Coefficient of Variation 5.8

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in haemoglobin (measured in millimoles per liter 'mmol/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Haemoglobin Change from week 0 to week 54	1.01 ratio of haemoglobin Geometric Coefficient of Variation 6.1	1.02 ratio of haemoglobin Geometric Coefficient of Variation 7.2	1.00 ratio of haemoglobin Geometric Coefficient of Variation 7.9	1.01 ratio of haemoglobin Geometric Coefficient of Variation 5.6
Change in Haematology: Haemoglobin Change from week 0 to week 80	1.00 ratio of haemoglobin Geometric Coefficient of Variation 7.5	1.02 ratio of haemoglobin Geometric Coefficient of Variation 8.2	1.00 ratio of haemoglobin Geometric Coefficient of Variation 7.4	1.01 ratio of haemoglobin Geometric Coefficient of Variation 5.6

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in leukocytes (measured in 10\^9 cells/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Leukocytes Change from week 0 to week 54	0.96 ratio of leukocytes Geometric Coefficient of Variation 27.1	0.98 ratio of leukocytes Geometric Coefficient of Variation 21.9	0.97 ratio of leukocytes Geometric Coefficient of Variation 23.2	1.02 ratio of leukocytes Geometric Coefficient of Variation 24.8
Change in Haematology: Leukocytes Change from week 0 to week 80	0.99 ratio of leukocytes Geometric Coefficient of Variation 33.0	0.95 ratio of leukocytes Geometric Coefficient of Variation 19.9	0.99 ratio of leukocytes Geometric Coefficient of Variation 29.5	1.00 ratio of leukocytes Geometric Coefficient of Variation 24.9

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in mean Corpuscular hemoglobin (measured in femtomole 'fmol') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Mean Corpuscular Hemoglobin Change from week 0 to week 54	1.02 ratio of mean Corpuscular hemoglobin Standard Deviation 3.6	1.01 ratio of mean Corpuscular hemoglobin Standard Deviation 4.8	1.01 ratio of mean Corpuscular hemoglobin Standard Deviation 4.0	1.01 ratio of mean Corpuscular hemoglobin Standard Deviation 4.1
Change in Haematology: Mean Corpuscular Hemoglobin Change from week 0 to week 80	1.02 ratio of mean Corpuscular hemoglobin Standard Deviation 5.1	1.01 ratio of mean Corpuscular hemoglobin Standard Deviation 6.6	1.01 ratio of mean Corpuscular hemoglobin Standard Deviation 5.4	1.02 ratio of mean Corpuscular hemoglobin Standard Deviation 4.3

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in mean corpuscular hemoglobin concentration (MCHC) (measured in gram per liter 'g/L') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Mean Corpuscular Hemoglobin Concentration Change from week 0 to week 54	1.02 Ratio of MCHC Geometric Coefficient of Variation 2.9	1.01 Ratio of MCHC Geometric Coefficient of Variation 2.1	1.02 Ratio of MCHC Geometric Coefficient of Variation 2.6	1.02 Ratio of MCHC Geometric Coefficient of Variation 3.0
Change in Haematology: Mean Corpuscular Hemoglobin Concentration Change from week 0 to week 80	1.02 Ratio of MCHC Geometric Coefficient of Variation 3.5	1.02 Ratio of MCHC Geometric Coefficient of Variation 3.1	1.02 Ratio of MCHC Geometric Coefficient of Variation 3.0	1.02 Ratio of MCHC Geometric Coefficient of Variation 0.29

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in Mean Corpuscular volume (measured in femtoliter 'fL') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Mean Corpuscular Volume Change from week 0 to week 54	1.00 ratio of mean corpuscular volume Geometric Coefficient of Variation 2.8	0.99 ratio of mean corpuscular volume Geometric Coefficient of Variation 3.8	1.00 ratio of mean corpuscular volume Geometric Coefficient of Variation 3.3	0.99 ratio of mean corpuscular volume Geometric Coefficient of Variation 3.3
Change in Haematology: Mean Corpuscular Volume Change from week 0 to week 80	1.00 ratio of mean corpuscular volume Geometric Coefficient of Variation 4.3	1.00 ratio of mean corpuscular volume Geometric Coefficient of Variation 5.2	1.00 ratio of mean corpuscular volume Geometric Coefficient of Variation 4.3	0.99 ratio of mean corpuscular volume Geometric Coefficient of Variation 3.7

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in thrombocytes (measured in 10\^9 cells per liter) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Thrombocytes Change from week 0 to week 54	0.98 ratio of thrombocytes Geometric Coefficient of Variation 14.5	0.98 ratio of thrombocytes Geometric Coefficient of Variation 15.0	1.03 ratio of thrombocytes Geometric Coefficient of Variation 13.2	0.98 ratio of thrombocytes Geometric Coefficient of Variation 14.1
Change in Haematology: Thrombocytes Change from week 0 to week 80	1.00 ratio of thrombocytes Geometric Coefficient of Variation 15.0	1.03 ratio of thrombocytes Geometric Coefficient of Variation 15.7	1.04 ratio of thrombocytes Geometric Coefficient of Variation 15.6	1.00 ratio of thrombocytes Geometric Coefficient of Variation 17.3

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in eosinophil (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Eosinophil Change from week 0 to week 54	1.15 Ratio of eosinophils Standard Deviation 0.65	1.30 Ratio of eosinophils Standard Deviation 1.71	3.10 Ratio of eosinophils Standard Deviation 13.79	1.37 Ratio of eosinophils Standard Deviation 1.15
Change in Haematology: Eosinophil Change from week 0 to week 80	1.31 Ratio of eosinophils Standard Deviation 1.24	1.23 Ratio of eosinophils Standard Deviation 1.03	1.54 Ratio of eosinophils Standard Deviation 1.78	1.36 Ratio of eosinophils Standard Deviation 1.27

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in neutrophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Neutrophils Change from week 0 to week 54	0.98 ratio of neutrophils Geometric Coefficient of Variation 18.8	0.99 ratio of neutrophils Geometric Coefficient of Variation 17.6	0.97 ratio of neutrophils Geometric Coefficient of Variation 18.5	1.04 ratio of neutrophils Geometric Coefficient of Variation 17.8
Change in Haematology: Neutrophils Change from week 0 to week 80	0.97 ratio of neutrophils Geometric Coefficient of Variation 17.5	0.99 ratio of neutrophils Geometric Coefficient of Variation 14.2	0.98 ratio of neutrophils Geometric Coefficient of Variation 20.7	1.04 ratio of neutrophils Geometric Coefficient of Variation 17.2

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in basophils (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Basophils Change from week 0 to week 54	1.73 Ratio of basophils Standard Deviation 2.11	1.58 Ratio of basophils Standard Deviation 1.52	1.52 Ratio of basophils Standard Deviation 1.47	1.43 Ratio of basophils Standard Deviation 1.06
Change in Haematology: Basophils Change from week 0 to week 80	2.17 Ratio of basophils Standard Deviation 2.17	1.73 Ratio of basophils Standard Deviation 1.41	2.09 Ratio of basophils Standard Deviation 1.86	1.96 Ratio of basophils Standard Deviation 1.27

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in lymphocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Lymphocytes Change from week 0 to week 54	1.00 ratio of lymphocytes Geometric Coefficient of Variation 28.5	1.00 ratio of lymphocytes Geometric Coefficient of Variation 28.3	1.02 ratio of lymphocytes Geometric Coefficient of Variation 28.4	0.91 ratio of lymphocytes Geometric Coefficient of Variation 30.7
Change in Haematology: Lymphocytes Change from week 0 to week 80	1.01 ratio of lymphocytes Geometric Coefficient of Variation 28.0	0.98 ratio of lymphocytes Geometric Coefficient of Variation 21.8	0.99 ratio of lymphocytes Geometric Coefficient of Variation 35.1	0.91 ratio of lymphocytes Geometric Coefficient of Variation 30.6

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in monocytes (measured in percentage '%') from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Haematology: Monocytes Change from week 0 to week 54	1.05 ratio of monocytes Geometric Coefficient of Variation 40.8	1.02 ratio of monocytes Geometric Coefficient of Variation 34.8	1.01 ratio of monocytes Geometric Coefficient of Variation 41.1	1.01 ratio of monocytes Geometric Coefficient of Variation 34.9
Change in Haematology: Monocytes Change from week 0 to week 80	1.12 ratio of monocytes Geometric Coefficient of Variation 44.0	1.07 ratio of monocytes Geometric Coefficient of Variation 37.5	1.04 ratio of monocytes Geometric Coefficient of Variation 42.9	1.12 ratio of monocytes Geometric Coefficient of Variation 35.4

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in ALAT (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Alanine Aminotransferase (ALAT) Change from week 0 to week 54	0.96 ratio of ALT Geometric Coefficient of Variation 47.7	0.98 ratio of ALT Geometric Coefficient of Variation 35.9	0.97 ratio of ALT Geometric Coefficient of Variation 46.0	0.90 ratio of ALT Geometric Coefficient of Variation 44.1
Change in Biochemistry: Alanine Aminotransferase (ALAT) Change from week 0 to week 80	0.95 ratio of ALT Geometric Coefficient of Variation 54.7	0.98 ratio of ALT Geometric Coefficient of Variation 39.5	1.06 ratio of ALT Geometric Coefficient of Variation 40.7	0.92 ratio of ALT Geometric Coefficient of Variation 40.6

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in albumin (measured in gram per deciliter \[g/dL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Albumin Change from week 0 to week 54	0.99 ratio of albumin Standard Deviation 7.3	1.00 ratio of albumin Standard Deviation 6.00	1.02 ratio of albumin Standard Deviation 7.4	0.99 ratio of albumin Standard Deviation 7.5
Change in Biochemistry: Albumin Change from week 0 to week 80	1.00 ratio of albumin Standard Deviation 6.7	1.01 ratio of albumin Standard Deviation 6.9	1.00 ratio of albumin Standard Deviation 6.7	0.99 ratio of albumin Standard Deviation 6.9

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in amylase (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Amylase Change from week 0 to week 54	1.07 ratio of Amylase Geometric Coefficient of Variation 20.7	0.98 ratio of Amylase Geometric Coefficient of Variation 16.6	1.04 ratio of Amylase Geometric Coefficient of Variation 18.9	1.01 ratio of Amylase Geometric Coefficient of Variation 19.2
Change in Biochemistry: Amylase Change from week 0 to week 80	1.04 ratio of Amylase Geometric Coefficient of Variation 24.3	0.99 ratio of Amylase Geometric Coefficient of Variation 14.9	1.03 ratio of Amylase Geometric Coefficient of Variation 19.8	1.04 ratio of Amylase Geometric Coefficient of Variation 26.1

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in ALP (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Alkaline Phosphatase (ALP) Change from week 0 to week 54	1.03 Ratio of ALP Geometric Coefficient of Variation 28.6	0.99 Ratio of ALP Geometric Coefficient of Variation 17.8	0.99 Ratio of ALP Geometric Coefficient of Variation 18.1	1.03 Ratio of ALP Geometric Coefficient of Variation 17.9
Change in Biochemistry: Alkaline Phosphatase (ALP) Change from week 0 to week 80	1.07 Ratio of ALP Geometric Coefficient of Variation 30.3	1.05 Ratio of ALP Geometric Coefficient of Variation 16.5	1.04 Ratio of ALP Geometric Coefficient of Variation 22.1	1.04 Ratio of ALP Geometric Coefficient of Variation 21.7

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in ASAT (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Aspartate Aminotransferase (ASAT) Change from week 0 to week 54	0.99 Ratio of AST Geometric Coefficient of Variation 39.3	0.99 Ratio of AST Geometric Coefficient of Variation 34.5	1.00 Ratio of AST Geometric Coefficient of Variation 57.0	0.98 Ratio of AST Geometric Coefficient of Variation 43.1
Change in Biochemistry: Aspartate Aminotransferase (ASAT) Change from week 0 to week 80	0.98 Ratio of AST Geometric Coefficient of Variation 39.1	0.98 Ratio of AST Geometric Coefficient of Variation 32.4	1.09 Ratio of AST Geometric Coefficient of Variation 34.6	0.99 Ratio of AST Geometric Coefficient of Variation 39.3

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in Total bilirubin (measured in micromole per liter \[umol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Total Bilirubin Change from week 0 to week 54	0.81 ratio of total bilirubin Geometric Coefficient of Variation 61.7	1.10 ratio of total bilirubin Geometric Coefficient of Variation 56.5	0.99 ratio of total bilirubin Geometric Coefficient of Variation 49.8	1.01 ratio of total bilirubin Geometric Coefficient of Variation 59.4
Change in Biochemistry: Total Bilirubin Change from week 0 to week 80	0.91 ratio of total bilirubin Geometric Coefficient of Variation 44.7	1.04 ratio of total bilirubin Geometric Coefficient of Variation 74.8	0.98 ratio of total bilirubin Geometric Coefficient of Variation 55.1	0.99 ratio of total bilirubin Geometric Coefficient of Variation 58.7

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in calcium corrected (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Calcium Corrected Change from week 0 to week 54	0.99 ratio of calcium Geometric Coefficient of Variation 3.7	0.98 ratio of calcium Geometric Coefficient of Variation 3.6	0.98 ratio of calcium Geometric Coefficient of Variation 4.0	0.99 ratio of calcium Geometric Coefficient of Variation 4.2
Change in Biochemistry: Calcium Corrected Change from week 0 to week 80	0.96 ratio of calcium Geometric Coefficient of Variation 3.5	0.97 ratio of calcium Geometric Coefficient of Variation 4.0	0.98 ratio of calcium Geometric Coefficient of Variation 3.9	0.98 ratio of calcium Geometric Coefficient of Variation 4.0

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in chloride (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Chloride Change from week 0 to week 54	1.01 ratio of chloride Geometric Coefficient of Variation 2.4	1.00 ratio of chloride Geometric Coefficient of Variation 2.2	1.00 ratio of chloride Geometric Coefficient of Variation 2.8	1.00 ratio of chloride Geometric Coefficient of Variation 3.1
Change in Biochemistry: Chloride Change from week 0 to week 80	1.00 ratio of chloride Geometric Coefficient of Variation 2.3	1.01 ratio of chloride Geometric Coefficient of Variation 2.7	1.00 ratio of chloride Geometric Coefficient of Variation 3.0	1.00 ratio of chloride Geometric Coefficient of Variation 3.0

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in creatine kinase (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Creatine Kinase Change from week 0 to week 54	1.16 Ratio of Creatine Kinase Geometric Coefficient of Variation 86.3	1.17 Ratio of Creatine Kinase Geometric Coefficient of Variation 64.5	1.08 Ratio of Creatine Kinase Geometric Coefficient of Variation 140.2	1.02 Ratio of Creatine Kinase Geometric Coefficient of Variation 72.8
Change in Biochemistry: Creatine Kinase Change from week 0 to week 80	1.11 Ratio of Creatine Kinase Geometric Coefficient of Variation 48.1	1.09 Ratio of Creatine Kinase Geometric Coefficient of Variation 68.3	1.24 Ratio of Creatine Kinase Geometric Coefficient of Variation 87.2	1.13 Ratio of Creatine Kinase Geometric Coefficient of Variation 76.5

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in creatinine (measured in micromole per liter \[umol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Creatinine Change from week 0 to week 80	1.02 Ratio of Creatinine Geometric Coefficient of Variation 11.2	1.05 Ratio of Creatinine Geometric Coefficient of Variation 14.3	1.05 Ratio of Creatinine Geometric Coefficient of Variation 13.1	1.02 Ratio of Creatinine Geometric Coefficient of Variation 12.3
Change in Biochemistry: Creatinine Change from week 0 to week 54	1.01 Ratio of Creatinine Geometric Coefficient of Variation 12.0	1.05 Ratio of Creatinine Geometric Coefficient of Variation 10.6	1.04 Ratio of Creatinine Geometric Coefficient of Variation 12.8	1.01 Ratio of Creatinine Geometric Coefficient of Variation 9.9

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in GGT (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Gamma-glutamyl Transferase (GGT) Change from week 0 to week 54	1.02 Ratio of GGT Geometric Coefficient of Variation 38.6	1.08 Ratio of GGT Geometric Coefficient of Variation 27.7	1.03 Ratio of GGT Geometric Coefficient of Variation 37.2	1.02 Ratio of GGT Geometric Coefficient of Variation 41.8
Change in Biochemistry: Gamma-glutamyl Transferase (GGT) Change from week 0 to week 80	1.05 Ratio of GGT Geometric Coefficient of Variation 41.9	1.13 Ratio of GGT Geometric Coefficient of Variation 29.4	1.10 Ratio of GGT Geometric Coefficient of Variation 41.1	1.00 Ratio of GGT Geometric Coefficient of Variation 36.8

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in C-reactive protein serum (measured in milligrams per liter \[mg/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: C-reactive Protein Serum Change from week 0 to week 54	0.92 Ratio of C-reactive protein Geometric Coefficient of Variation 141.6	1.04 Ratio of C-reactive protein Geometric Coefficient of Variation 93.0	0.89 Ratio of C-reactive protein Geometric Coefficient of Variation 87.8	1.06 Ratio of C-reactive protein Geometric Coefficient of Variation 78.0
Change in Biochemistry: C-reactive Protein Serum Change from week 0 to week 80	1.08 Ratio of C-reactive protein Geometric Coefficient of Variation 103.8	0.94 Ratio of C-reactive protein Geometric Coefficient of Variation 81.0	1.25 Ratio of C-reactive protein Geometric Coefficient of Variation 134.7	1.06 Ratio of C-reactive protein Geometric Coefficient of Variation 70.1

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in Lactate Dehydrogenase (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Lactate Dehydrogenase Change from week 0 to week 54	0.99 Ratio of Lactate Dehydrogenase Geometric Coefficient of Variation 12.6	1.03 Ratio of Lactate Dehydrogenase Geometric Coefficient of Variation 18.4	1.04 Ratio of Lactate Dehydrogenase Geometric Coefficient of Variation 23.3	1.03 Ratio of Lactate Dehydrogenase Geometric Coefficient of Variation 16.5
Change in Biochemistry: Lactate Dehydrogenase Change from week 0 to week 80	1.02 Ratio of Lactate Dehydrogenase Geometric Coefficient of Variation 12.1	1.04 Ratio of Lactate Dehydrogenase Geometric Coefficient of Variation 19.6	1.09 Ratio of Lactate Dehydrogenase Geometric Coefficient of Variation 19.3	1.03 Ratio of Lactate Dehydrogenase Geometric Coefficient of Variation 17.8

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in lipase (measured in units per liter \[U/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Lipase Change from week 0 to week 54	1.49 Ratio of lipase Geometric Coefficient of Variation 36.6	1.00 Ratio of lipase Geometric Coefficient of Variation 27.4	1.34 Ratio of lipase Geometric Coefficient of Variation 36.2	1.01 Ratio of lipase Geometric Coefficient of Variation 29.4
Change in Biochemistry: Lipase Change from week 0 to week 80	1.05 Ratio of lipase Geometric Coefficient of Variation 40.4	0.94 Ratio of lipase Geometric Coefficient of Variation 27.2	1.02 Ratio of lipase Geometric Coefficient of Variation 26.5	0.96 Ratio of lipase Geometric Coefficient of Variation 37.2

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in magnesium (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Magnesium Change from week 0 to week 54	1.02 Ratio of magnesium Geometric Coefficient of Variation 8.9	1.01 Ratio of magnesium Geometric Coefficient of Variation 7.6	1.02 Ratio of magnesium Geometric Coefficient of Variation 7.8	0.99 Ratio of magnesium Geometric Coefficient of Variation 8.1
Change in Biochemistry: Magnesium Change from week 0 to week 80	1.01 Ratio of magnesium Geometric Coefficient of Variation 10.7	1.03 Ratio of magnesium Geometric Coefficient of Variation 11.2	1.02 Ratio of magnesium Geometric Coefficient of Variation 9.0	0.98 Ratio of magnesium Geometric Coefficient of Variation 9.2

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in phosphate (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Phosphate Change from week 0 to week 54	0.99 Ratio of phosphate Geometric Coefficient of Variation 16.0	0.99 Ratio of phosphate Geometric Coefficient of Variation 16.6	1.02 Ratio of phosphate Geometric Coefficient of Variation 13.9	0.96 Ratio of phosphate Geometric Coefficient of Variation 18.6
Change in Biochemistry: Phosphate Change from week 0 to week 80	1.02 Ratio of phosphate Geometric Coefficient of Variation 20.5	1.01 Ratio of phosphate Geometric Coefficient of Variation 16.9	1.03 Ratio of phosphate Geometric Coefficient of Variation 19.9	0.99 Ratio of phosphate Geometric Coefficient of Variation 17.4

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in potassium (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Potassium Change from week 0 to week 54	1.01 Ratio of potassium Geometric Coefficient of Variation 8.1	0.98 Ratio of potassium Geometric Coefficient of Variation 6.9	0.99 Ratio of potassium Geometric Coefficient of Variation 8.3	0.98 Ratio of potassium Geometric Coefficient of Variation 10.4
Change in Biochemistry: Potassium Change from week 0 to week 80	0.99 Ratio of potassium Geometric Coefficient of Variation 8.3	0.99 Ratio of potassium Geometric Coefficient of Variation 6.9	0.98 Ratio of potassium Geometric Coefficient of Variation 8.5	0.98 Ratio of potassium Geometric Coefficient of Variation 10.0

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in sodium (measured in millimole per liter \[mmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Sodium Change from week 0 to week 54	1.00 Ratio of sodium Geometric Coefficient of Variation 1.9	1.00 Ratio of sodium Geometric Coefficient of Variation 1.4	1.00 Ratio of sodium Geometric Coefficient of Variation 1.9	1.00 Ratio of sodium Geometric Coefficient of Variation 2.0
Change in Biochemistry: Sodium Change from week 0 to week 80	0.99 Ratio of sodium Geometric Coefficient of Variation 1.8	1.00 Ratio of sodium Geometric Coefficient of Variation 2.1	1.00 Ratio of sodium Geometric Coefficient of Variation 2.3	1.00 Ratio of sodium Geometric Coefficient of Variation 1.8

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in total protein (measured in gram per liter \[g/dL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Total Protein Change from week 0 to week 54	0.99 Ratio of total protein Geometric Coefficient of Variation 6.8	1.00 Ratio of total protein Geometric Coefficient of Variation 6.0	1.01 Ratio of total protein Geometric Coefficient of Variation 7.2	1.00 Ratio of total protein Geometric Coefficient of Variation 7.6
Change in Biochemistry: Total Protein Change from week 0 to week 80	0.99 Ratio of total protein Geometric Coefficient of Variation 6.5	1.00 Ratio of total protein Geometric Coefficient of Variation 6.4	1.00 Ratio of total protein Geometric Coefficient of Variation 6.6	1.00 Ratio of total protein Geometric Coefficient of Variation 7.4

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in blood urea nitrogen serum (measured in milligram per deciliter \[mg/dL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Blood Urea Nitrogen Serum Change from week 0 to week 54	1.00 Ratio of Blood Urea Nitrogen serum Geometric Coefficient of Variation 27.0	1.05 Ratio of Blood Urea Nitrogen serum Geometric Coefficient of Variation 22.4	0.98 Ratio of Blood Urea Nitrogen serum Geometric Coefficient of Variation 22.0	0.94 Ratio of Blood Urea Nitrogen serum Geometric Coefficient of Variation 23.3
Change in Biochemistry: Blood Urea Nitrogen Serum Change from week 0 to week 80	0.97 Ratio of Blood Urea Nitrogen serum Geometric Coefficient of Variation 33.2	0.97 Ratio of Blood Urea Nitrogen serum Geometric Coefficient of Variation 26.2	0.98 Ratio of Blood Urea Nitrogen serum Geometric Coefficient of Variation 28.9	0.97 Ratio of Blood Urea Nitrogen serum Geometric Coefficient of Variation 28.2

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in Uric Acid (measured in milligram per deciliter \[mg/dL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biochemistry: Uric Acid Change from week 0 to week 54	0.93 Ratio of uric acid Geometric Coefficient of Variation 21.3	0.98 Ratio of uric acid Geometric Coefficient of Variation 17.6	0.98 Ratio of uric acid Geometric Coefficient of Variation 18.8	0.96 Ratio of uric acid Geometric Coefficient of Variation 18.0
Change in Biochemistry: Uric Acid Change from week 0 to week 80	0.95 Ratio of uric acid Geometric Coefficient of Variation 17.1	0.94 Ratio of uric acid Geometric Coefficient of Variation 19.1	0.96 Ratio of uric acid Geometric Coefficient of Variation 22.2	0.95 Ratio of uric acid Geometric Coefficient of Variation 19.6

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in INR (measured in ratio\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in International Normalised Ratio (INR) Change from week 0 to week 54	0.97 Ratio of INR Geometric Coefficient of Variation 9.5	0.96 Ratio of INR Geometric Coefficient of Variation 10.4	0.95 Ratio of INR Geometric Coefficient of Variation 9.8	0.96 Ratio of INR Geometric Coefficient of Variation 13.7
Change in International Normalised Ratio (INR) Change from week 0 to week 80	0.98 Ratio of INR Geometric Coefficient of Variation 12.4	0.99 Ratio of INR Geometric Coefficient of Variation 12.9	0.96 Ratio of INR Geometric Coefficient of Variation 9.2	0.97 Ratio of INR Geometric Coefficient of Variation 11.5

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in D-Dimer (measured in mg/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in D-Dimer Change from week 0 to week 54	0.96 Ratio of D-dimer Geometric Coefficient of Variation 37.6	0.98 Ratio of D-dimer Geometric Coefficient of Variation 53.9	0.98 Ratio of D-dimer Geometric Coefficient of Variation 56.8	1.15 Ratio of D-dimer Geometric Coefficient of Variation 107.1
Change in D-Dimer Change from week 0 to week 80	0.96 Ratio of D-dimer Geometric Coefficient of Variation 43.7	0.92 Ratio of D-dimer Geometric Coefficient of Variation 61.3	1.05 Ratio of D-dimer Geometric Coefficient of Variation 60.0	1.10 Ratio of D-dimer Geometric Coefficient of Variation 74.3

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in total cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Lipids: Total Cholesterol (Ratio to Baseline) Change from week 0 to week 54	1.00 Ratio of total cholesterol Geometric Coefficient of Variation 13.8	1.02 Ratio of total cholesterol Geometric Coefficient of Variation 14.1	1.03 Ratio of total cholesterol Geometric Coefficient of Variation 16.2	1.04 Ratio of total cholesterol Geometric Coefficient of Variation 16.8
Change in Lipids: Total Cholesterol (Ratio to Baseline) Change from week 0 to week 80	1.02 Ratio of total cholesterol Geometric Coefficient of Variation 15.5	1.03 Ratio of total cholesterol Geometric Coefficient of Variation 14.1	1.07 Ratio of total cholesterol Geometric Coefficient of Variation 15.0	1.03 Ratio of total cholesterol Geometric Coefficient of Variation 18.4

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in total free fatty acids (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Lipids: Free Fatty Acids (Ratio to Baseline) Change from week 0 to week 54	0.86 Ratio of free fatty acids Geometric Coefficient of Variation 94.5	1.01 Ratio of free fatty acids Geometric Coefficient of Variation 114.4	1.18 Ratio of free fatty acids Geometric Coefficient of Variation 82.5	0.97 Ratio of free fatty acids Geometric Coefficient of Variation 68.7
Change in Lipids: Free Fatty Acids (Ratio to Baseline) Change from week 0 to week 80	0.89 Ratio of free fatty acids Geometric Coefficient of Variation 85.3	1.06 Ratio of free fatty acids Geometric Coefficient of Variation 112.8	1.19 Ratio of free fatty acids Geometric Coefficient of Variation 92.8	0.94 Ratio of free fatty acids Geometric Coefficient of Variation 84.0

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in HDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Lipids: HDL Cholesterol (Ratio to Baseline) Change from week 0 to week 54	1.04 Ratio of HDL cholesterol Geometric Coefficient of Variation 17.3	1.08 Ratio of HDL cholesterol Geometric Coefficient of Variation 18.2	1.12 Ratio of HDL cholesterol Geometric Coefficient of Variation 19.6	1.10 Ratio of HDL cholesterol Geometric Coefficient of Variation 20.2
Change in Lipids: HDL Cholesterol (Ratio to Baseline) Change from week 0 to week 80	1.04 Ratio of HDL cholesterol Geometric Coefficient of Variation 18.7	1.06 Ratio of HDL cholesterol Geometric Coefficient of Variation 16.7	1.14 Ratio of HDL cholesterol Geometric Coefficient of Variation 21.5	1.07 Ratio of HDL cholesterol Geometric Coefficient of Variation 22.2

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in LDL cholesterol (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Lipids: LDL Cholesterol (Ratio to Baseline) Change from week 0 to week 54	0.96 Ratio of LDL cholesterol Geometric Coefficient of Variation 17.8	0.97 Ratio of LDL cholesterol Geometric Coefficient of Variation 20.9	0.98 Ratio of LDL cholesterol Geometric Coefficient of Variation 24.0	1.01 Ratio of LDL cholesterol Geometric Coefficient of Variation 23.6
Change in Lipids: LDL Cholesterol (Ratio to Baseline) Change from week 0 to week 80	0.99 Ratio of LDL cholesterol Geometric Coefficient of Variation 22.2	1.02 Ratio of LDL cholesterol Geometric Coefficient of Variation 21.2	1.02 Ratio of LDL cholesterol Geometric Coefficient of Variation 21.2	1.03 Ratio of LDL cholesterol Geometric Coefficient of Variation 29.2

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in Triglycerides (measured in mmol/L) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Lipids: Triglycerides (TG) (Ratio to Baseline) Change from week 0 to week 54	1.03 Ratio of TG Geometric Coefficient of Variation 46.2	0.96 Ratio of TG Geometric Coefficient of Variation 39.5	1.03 Ratio of TG Geometric Coefficient of Variation 49.2	1.02 Ratio of TG Geometric Coefficient of Variation 54.7
Change in Lipids: Triglycerides (TG) (Ratio to Baseline) Change from week 0 to week 80	1.08 Ratio of TG Geometric Coefficient of Variation 45.6	0.94 Ratio of TG Geometric Coefficient of Variation 45.1	1.09 Ratio of TG Geometric Coefficient of Variation 51.5	0.95 Ratio of TG Geometric Coefficient of Variation 50.4

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in IgE (measured in kilo international units per liter \[kIU/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Total Immunoglobulin E (IgE) Change from week 0 to week 54	1.31 Ratio of IgE Geometric Coefficient of Variation 71.6	1.05 Ratio of IgE Geometric Coefficient of Variation 63.1	1.08 Ratio of IgE Geometric Coefficient of Variation 45.7	1.02 Ratio of IgE Geometric Coefficient of Variation 41.8
Change in Total Immunoglobulin E (IgE) Change from week 0 to week 80	1.32 Ratio of IgE Geometric Coefficient of Variation 65.4	1.18 Ratio of IgE Geometric Coefficient of Variation 38.5	1.16 Ratio of IgE Geometric Coefficient of Variation 55.1	0.94 Ratio of IgE Geometric Coefficient of Variation 61.2

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Urinalysis was performed by urine dipsticks for protein, glucose, erythrocytes, ketones leukocytes, nitrite, pH and specific gravity and categorised as normal, abnormal not clinically significant (NCS) and abnormal clinially significant (CS). Number of participants in each category at baseline (week 0), week 54 and 80 are presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Urinalysis: Urine Dipsticks Week 0: Glucose dipstick · Normal	72 Participants	71 Participants	67 Participants	71 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Glucose dipstick · Abnormal, NCS	5 Participants	6 Participants	9 Participants	6 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Glucose dipstick · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Glucose dipstick · Normal	57 Participants	56 Participants	63 Participants	59 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Glucose dipstick · Abnormal, NCS	9 Participants	9 Participants	5 Participants	6 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Glucose dipstick · Abnormal, CS	2 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Glucose dipstick · Normal	54 Participants	54 Participants	54 Participants	51 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Glucose dipstick · Abnormal, NCS	12 Participants	10 Participants	13 Participants	11 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Glucose dipstick · Abnormal, CS	0 Participants	0 Participants	1 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Ketone dipstick · Normal	74 Participants	73 Participants	73 Participants	76 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Ketone dipstick · Abnormal, NCS	2 Participants	4 Participants	3 Participants	1 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Ketone dipstick · Abnormal, CS	1 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Ketone dipstick · Normal	68 Participants	64 Participants	65 Participants	64 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Ketone dipstick · Abnormal, NCS	0 Participants	1 Participants	3 Participants	1 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Ketone dipstick · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Ketone dipstick · Normal	65 Participants	61 Participants	66 Participants	61 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Ketone dipstick · Abnormal, NCS	1 Participants	3 Participants	1 Participants	1 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Ketone dipstick · Abnormal, CS	0 Participants	0 Participants	1 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 0: pH dipstick · Normal	75 Participants	77 Participants	76 Participants	75 Participants
Change in Urinalysis: Urine Dipsticks Week 0: pH dipstick · Abnormal, NCS	2 Participants	0 Participants	0 Participants	2 Participants
Change in Urinalysis: Urine Dipsticks Week 0: pH dipstick · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 54: pH dipstick · Normal	67 Participants	65 Participants	68 Participants	64 Participants
Change in Urinalysis: Urine Dipsticks Week 54: pH dipstick · Abnormal, NCS	1 Participants	0 Participants	0 Participants	1 Participants
Change in Urinalysis: Urine Dipsticks Week 54: pH dipstick · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 80: pH dipstick · Normal	66 Participants	64 Participants	68 Participants	62 Participants
Change in Urinalysis: Urine Dipsticks Week 80: pH dipstick · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 80: pH dipstick · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Erythrocytes in urine · Normal	74 Participants	74 Participants	74 Participants	72 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Erythrocytes in urine · Abnormal, NCS	2 Participants	3 Participants	2 Participants	4 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Erythrocytes in urine · Abnormal, CS	1 Participants	0 Participants	0 Participants	1 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Erythrocytes in urine · Normal	66 Participants	63 Participants	66 Participants	63 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Erythrocytes in urine · Abnormal, NCS	2 Participants	2 Participants	2 Participants	2 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Erythrocytes in urine · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Erythrocytes in urine · Normal	63 Participants	61 Participants	65 Participants	60 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Erythrocytes in urine · Abnormal, NCS	3 Participants	3 Participants	3 Participants	2 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Erythrocytes in urine · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Leukocytes in urine · Normal	77 Participants	73 Participants	76 Participants	77 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Leukocytes in urine · Abnormal, NCS	0 Participants	4 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Leukocytes in urine · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Leukocytes in urine · Normal	64 Participants	62 Participants	67 Participants	64 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Leukocytes in urine · Abnormal, NCS	4 Participants	3 Participants	1 Participants	1 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Leukocytes in urine · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Leukocytes in urine · Normal	62 Participants	61 Participants	67 Participants	60 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Leukocytes in urine · Abnormal, NCS	4 Participants	3 Participants	1 Participants	2 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Leukocytes in urine · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Nitrite · Normal	77 Participants	77 Participants	76 Participants	77 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Nitrite · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Nitrite · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Nitrite · Normal	68 Participants	65 Participants	68 Participants	65 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Nitrite · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Nitrite · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Nitrite · Normal	65 Participants	64 Participants	68 Participants	61 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Nitrite · Abnormal, NCS	1 Participants	0 Participants	0 Participants	1 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Nitrite · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Protein urine · Normal	77 Participants	71 Participants	75 Participants	76 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Protein urine · Abnormal, NCS	0 Participants	6 Participants	1 Participants	1 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Protein urine · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Protein urine · Normal	67 Participants	64 Participants	62 Participants	61 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Protein urine · Abnormal, NCS	1 Participants	1 Participants	6 Participants	4 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Protein urine · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Protein urine · Normal	63 Participants	62 Participants	65 Participants	59 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Protein urine · Abnormal, NCS	3 Participants	1 Participants	3 Participants	2 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Protein urine · Abnormal, CS	0 Participants	1 Participants	0 Participants	1 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Specific Gravity · Normal	75 Participants	77 Participants	76 Participants	75 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Specific Gravity · Abnormal, NCS	2 Participants	0 Participants	0 Participants	2 Participants
Change in Urinalysis: Urine Dipsticks Week 0: Specific Gravity · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Specific Gravity · Normal	67 Participants	65 Participants	68 Participants	64 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Specific Gravity · Abnormal, NCS	1 Participants	0 Participants	0 Participants	1 Participants
Change in Urinalysis: Urine Dipsticks Week 54: Specific Gravity · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Specific Gravity · Normal	65 Participants	64 Participants	68 Participants	62 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Specific Gravity · Abnormal, NCS	1 Participants	0 Participants	0 Participants	0 Participants
Change in Urinalysis: Urine Dipsticks Week 80: Specific Gravity · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

IL-6 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Cytokines: Interleukin (IL)-6 Week 0	0.9 picogram per milliliter (pg/mL) Standard Deviation 0.6	0.8 picogram per milliliter (pg/mL) Standard Deviation 0.1	1.2 picogram per milliliter (pg/mL) Standard Deviation 1.8	0.8 picogram per milliliter (pg/mL) Standard Deviation 0.3
Change in Cytokines: Interleukin (IL)-6 Week 54	0.8 picogram per milliliter (pg/mL) Standard Deviation 0.3	0.8 picogram per milliliter (pg/mL) Standard Deviation 0.4	1.0 picogram per milliliter (pg/mL) Standard Deviation 0.8	0.8 picogram per milliliter (pg/mL) Standard Deviation 0.2
Change in Cytokines: Interleukin (IL)-6 Week 80	0.9 picogram per milliliter (pg/mL) Standard Deviation 0.4	0.8 picogram per milliliter (pg/mL) Standard Deviation 0.2	0.9 picogram per milliliter (pg/mL) Standard Deviation 0.8	0.9 picogram per milliliter (pg/mL) Standard Deviation 0.4

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

IL-10 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Cytokines- Interleukin (IL)-10 Week 0	0.7 pg/mL Standard Deviation 1.4	0.5 pg/mL Standard Deviation 1.1	0.4 pg/mL Standard Deviation 0.3	0.4 pg/mL Standard Deviation 0.2
Change in Cytokines- Interleukin (IL)-10 Week 54	0.4 pg/mL Standard Deviation 0.2	0.4 pg/mL Standard Deviation 0.1	0.4 pg/mL Standard Deviation 0.3	0.4 pg/mL Standard Deviation 0.3
Change in Cytokines- Interleukin (IL)-10 Week 80	0.4 pg/mL Standard Deviation 0.5	0.4 pg/mL Standard Deviation 0.2	0.5 pg/mL Standard Deviation 0.7	0.4 pg/mL Standard Deviation 0.1

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

IL-17 levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Cytokines: Interleukin (IL)-17 Week 0	4.9 pg/mL Standard Deviation 2.0	4.7 pg/mL Standard Deviation 0.7	4.7 pg/mL Standard Deviation 0.0	4.8 pg/mL Standard Deviation 0.9
Change in Cytokines: Interleukin (IL)-17 Week 54	4.9 pg/mL Standard Deviation 1.9	4.8 pg/mL Standard Deviation 1.3	5.1 pg/mL Standard Deviation 3.5	5.4 pg/mL Standard Deviation 5.0
Change in Cytokines: Interleukin (IL)-17 Week 80	4.9 pg/mL Standard Deviation 1.7	4.7 pg/mL Standard Deviation 0.0	4.8 pg/mL Standard Deviation 1.2	4.8 pg/mL Standard Deviation 1.0

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

IFN gamma levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Cytokines: Interferon (IFN) Gamma Week 0	7.3 pg/mL Standard Deviation 16.1	7.8 pg/mL Standard Deviation 24.0	5.8 pg/mL Standard Deviation 11.6	4.3 pg/mL Standard Deviation 2.8
Change in Cytokines: Interferon (IFN) Gamma Week 54	4.6 pg/mL Standard Deviation 4.2	7.5 pg/mL Standard Deviation 19.6	5.0 pg/mL Standard Deviation 6.8	5.8 pg/mL Standard Deviation 7.0
Change in Cytokines: Interferon (IFN) Gamma Week 80	4.4 pg/mL Standard Deviation 2.8	4.9 pg/mL Standard Deviation 6.4	13.0 pg/mL Standard Deviation 57.5	4.5 pg/mL Standard Deviation 3.4

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

TNF-alpha levels at baseline (week 0), weeks 54 and 80 are evaluated and presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Cytokines: TNF-alpha Week 0	2.60 pg/mL Standard Deviation 1.69	2.32 pg/mL Standard Deviation 0.82	2.70 pg/mL Standard Deviation 1.73	3.06 pg/mL Standard Deviation 3.75
Change in Cytokines: TNF-alpha Week 54	2.36 pg/mL Standard Deviation 0.75	2.33 pg/mL Standard Deviation 0.59	2.56 pg/mL Standard Deviation 1.11	2.43 pg/mL Standard Deviation 0.65
Change in Cytokines: TNF-alpha Week 80	2.43 pg/mL Standard Deviation 0.66	2.36 pg/mL Standard Deviation 0.68	2.96 pg/mL Standard Deviation 2.39	2.75 pg/mL Standard Deviation 2.47

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in TSH (measured in milli international units per liter \[mIU/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) Change from week 0 to week 54	1.00 Ratio of Thyroid Stimulating Hormone Geometric Coefficient of Variation 49.9	1.12 Ratio of Thyroid Stimulating Hormone Geometric Coefficient of Variation 54.1	0.89 Ratio of Thyroid Stimulating Hormone Geometric Coefficient of Variation 46.6	0.91 Ratio of Thyroid Stimulating Hormone Geometric Coefficient of Variation 66.1
Change in Hormone Level: Thyroid Stimulating Hormone (TSH) Change from week 0 to week 80	1.04 Ratio of Thyroid Stimulating Hormone Geometric Coefficient of Variation 46.7	0.99 Ratio of Thyroid Stimulating Hormone Geometric Coefficient of Variation 116.1	0.99 Ratio of Thyroid Stimulating Hormone Geometric Coefficient of Variation 48.5	0.93 Ratio of Thyroid Stimulating Hormone Geometric Coefficient of Variation 84.5

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in Calcitonin (measured in nanogram per liter \[ng/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Hormone Level: Calcitonin Change from week 0 to week 54	1.00 Ratio of Calcitonin Geometric Coefficient of Variation 43.5	0.90 Ratio of Calcitonin Geometric Coefficient of Variation 48.5	0.89 Ratio of Calcitonin Geometric Coefficient of Variation 57.2	0.88 Ratio of Calcitonin Geometric Coefficient of Variation 47.4
Change in Hormone Level: Calcitonin Change from week 0 to week 80	0.85 Ratio of Calcitonin Geometric Coefficient of Variation 50.9	0.93 Ratio of Calcitonin Geometric Coefficient of Variation 41.8	0.82 Ratio of Calcitonin Geometric Coefficient of Variation 71.5	0.90 Ratio of Calcitonin Geometric Coefficient of Variation 64.5

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) are evaluated from baseline (week 0) to weeks 54 and 80.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Systolic and Diastolic Blood Pressure Week 54: Systolic blood pressure	-3 Millimeters of mercury (mmHg) Standard Deviation 9	3 Millimeters of mercury (mmHg) Standard Deviation 9	-2 Millimeters of mercury (mmHg) Standard Deviation 14	1 Millimeters of mercury (mmHg) Standard Deviation 11
Change in Systolic and Diastolic Blood Pressure Week 80: Systolic blood pressure	-1 Millimeters of mercury (mmHg) Standard Deviation 10	2 Millimeters of mercury (mmHg) Standard Deviation 11	1 Millimeters of mercury (mmHg) Standard Deviation 12	4 Millimeters of mercury (mmHg) Standard Deviation 10
Change in Systolic and Diastolic Blood Pressure Week 54: Diastolic blood pressure	-0 Millimeters of mercury (mmHg) Standard Deviation 9	2 Millimeters of mercury (mmHg) Standard Deviation 9	-1 Millimeters of mercury (mmHg) Standard Deviation 10	-1 Millimeters of mercury (mmHg) Standard Deviation 8
Change in Systolic and Diastolic Blood Pressure Week 80: Diastolic blood pressure	-0 Millimeters of mercury (mmHg) Standard Deviation 9	2 Millimeters of mercury (mmHg) Standard Deviation 9	1 Millimeters of mercury (mmHg) Standard Deviation 10	1 Millimeters of mercury (mmHg) Standard Deviation 10

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in pulse is evaluated from baseline (week 0) to weeks 54 and 80

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Pulse Change from week 0 to week 54	3 Beats/min Standard Deviation 12	0 Beats/min Standard Deviation 12	6 Beats/min Standard Deviation 9	2 Beats/min Standard Deviation 8
Change in Pulse Change from week 0 to week 80	-1 Beats/min Standard Deviation 10	-1 Beats/min Standard Deviation 10	2 Beats/min Standard Deviation 10	1 Beats/min Standard Deviation 9

SECONDARY outcome

Timeframe: Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in body temperature is evaluated from baseline (week 0) to weeks 54 and 80.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Body Temperature Change from week 0 to week 54	-0.1 Degree celsius (C) Standard Deviation 0.4	0.0 Degree celsius (C) Standard Deviation 0.6	-0.1 Degree celsius (C) Standard Deviation 0.5	-0.0 Degree celsius (C) Standard Deviation 0.3
Change in Body Temperature Change from week 0 to week 80	-0.0 Degree celsius (C) Standard Deviation 0.4	0.1 Degree celsius (C) Standard Deviation 0.5	0.0 Degree celsius (C) Standard Deviation 0.5	0.0 Degree celsius (C) Standard Deviation 0.4

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Change in respiratory rate is evaluated from baseline (week 0) to weeks 54 and 80.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Respiratory Rate Change from week 0 to week 54	-0.3 Breaths per minute Standard Deviation 2.2	0.1 Breaths per minute Standard Deviation 3.0	0.1 Breaths per minute Standard Deviation 2.5	0.6 Breaths per minute Standard Deviation 2.4
Change in Respiratory Rate Change from week 0 to week 80	-0.3 Breaths per minute Standard Deviation 2.0	-0.2 Breaths per minute Standard Deviation 2.7	0.1 Breaths per minute Standard Deviation 2.5	0.1 Breaths per minute Standard Deviation 2.2

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

The ECG was assessed by the investigator at baseline (week 0), week 54 and week 80 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline, week 54 and week 80 are presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Electrocardiogram (ECG) Week 80 · Normal	51 Participants	48 Participants	53 Participants	50 Participants
Change in Electrocardiogram (ECG) Week 0 · Normal	62 Participants	65 Participants	60 Participants	63 Participants
Change in Electrocardiogram (ECG) Week 0 · Abnormal, NCS	15 Participants	12 Participants	16 Participants	13 Participants
Change in Electrocardiogram (ECG) Week 0 · Abnormal, CS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Electrocardiogram (ECG) Week 54 · Normal	54 Participants	48 Participants	55 Participants	46 Participants
Change in Electrocardiogram (ECG) Week 54 · Abnormal, NCS	14 Participants	17 Participants	12 Participants	19 Participants
Change in Electrocardiogram (ECG) Week 54 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Electrocardiogram (ECG) Week 80 · Abnormal, NCS	15 Participants	16 Participants	15 Participants	12 Participants
Change in Electrocardiogram (ECG) Week 80 · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Dilated fundoscopy or fundus photography was performed by the investigator at week 0, week 54 and week 80. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week 0, week 54 and week 80 are presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Eye-examination Week 80: Right eye ophthalmoscopy · Normal	52 Participants	53 Participants	58 Participants	51 Participants
Change in Eye-examination Week 0: Left eye ophthalmoscopy · Normal	64 Participants	68 Participants	70 Participants	66 Participants
Change in Eye-examination Week 0: Left eye ophthalmoscopy · Abnormal, NCS	13 Participants	9 Participants	6 Participants	11 Participants
Change in Eye-examination Week 0: Left eye ophthalmoscopy · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Eye-examination Week 54: Left eye ophthalmoscopy · Normal	55 Participants	56 Participants	60 Participants	54 Participants
Change in Eye-examination Week 54: Left eye ophthalmoscopy · Abnormal, NCS	12 Participants	7 Participants	9 Participants	9 Participants
Change in Eye-examination Week 54: Left eye ophthalmoscopy · Abnormal, CS	1 Participants	0 Participants	0 Participants	1 Participants
Change in Eye-examination Week 80: Left eye ophthalmoscopy · Normal	52 Participants	54 Participants	59 Participants	51 Participants
Change in Eye-examination Week 80: Left eye ophthalmoscopy · Abnormal, NCS	11 Participants	8 Participants	6 Participants	8 Participants
Change in Eye-examination Week 80: Left eye ophthalmoscopy · Abnormal, CS	3 Participants	0 Participants	0 Participants	0 Participants
Change in Eye-examination Week 0: Right eye ophthalmoscopy · Normal	58 Participants	66 Participants	69 Participants	67 Participants
Change in Eye-examination Week 0: Right eye ophthalmoscopy · Abnormal, NCS	18 Participants	11 Participants	7 Participants	10 Participants
Change in Eye-examination Week 0: Right eye ophthalmoscopy · Abnormal, CS	1 Participants	0 Participants	0 Participants	0 Participants
Change in Eye-examination Week 54: Right eye ophthalmoscopy · Normal	55 Participants	55 Participants	60 Participants	55 Participants
Change in Eye-examination Week 54: Right eye ophthalmoscopy · Abnormal, NCS	13 Participants	8 Participants	9 Participants	8 Participants
Change in Eye-examination Week 54: Right eye ophthalmoscopy · Abnormal, CS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Eye-examination Week 80: Right eye ophthalmoscopy · Abnormal, NCS	12 Participants	9 Participants	7 Participants	8 Participants
Change in Eye-examination Week 80: Right eye ophthalmoscopy · Abnormal, CS	2 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

Physical examination parameters are categorised as general appearance; head, ears, eyes, nose, throat, neck; respiratory system;cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; skin; lymph node palpation and thyroid gland. Investigator assessed the participants with normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) findings at week 0, week 54 and week 80 are presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Physical Examination Week 80: Gastrointestinal System incl. Mouth · Abnormal, NCS	0 Participants	1 Participants	0 Participants	1 Participants
Change in Physical Examination Week 80: Gastrointestinal System incl. Mouth · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 0: Musculoskeletal System · Normal	76 Participants	75 Participants	74 Participants	77 Participants
Change in Physical Examination Week 0: Musculoskeletal System · Abnormal, NCS	1 Participants	2 Participants	2 Participants	0 Participants
Change in Physical Examination Week 0: Musculoskeletal System · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: Musculoskeletal System · Normal	65 Participants	63 Participants	66 Participants	65 Participants
Change in Physical Examination Week 54: Musculoskeletal System · Abnormal, NCS	1 Participants	2 Participants	0 Participants	1 Participants
Change in Physical Examination Week 54: Musculoskeletal System · Abnormal, CS	2 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: Musculoskeletal System · Normal	66 Participants	64 Participants	68 Participants	62 Participants
Change in Physical Examination Week 80: Musculoskeletal System · Abnormal, NCS	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: Musculoskeletal System · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 0: Central and Peripheral Nervous System · Normal	77 Participants	76 Participants	76 Participants	76 Participants
Change in Physical Examination Week 0: Central and Peripheral Nervous System · Abnormal, NCS	0 Participants	1 Participants	0 Participants	1 Participants
Change in Physical Examination Week 0: Central and Peripheral Nervous System · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: Central and Peripheral Nervous System · Normal	68 Participants	64 Participants	66 Participants	65 Participants
Change in Physical Examination Week 54: Central and Peripheral Nervous System · Abnormal, NCS	0 Participants	1 Participants	0 Participants	1 Participants
Change in Physical Examination Week 54: Central and Peripheral Nervous System · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: Central and Peripheral Nervous System · Normal	66 Participants	63 Participants	68 Participants	62 Participants
Change in Physical Examination Week 0: General Appearance · Normal	76 Participants	77 Participants	76 Participants	76 Participants
Change in Physical Examination Week 0: General Appearance · Abnormal, NCS	1 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination Week 0: General Appearance · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: General Appearance · Normal	68 Participants	64 Participants	66 Participants	65 Participants
Change in Physical Examination Week 54: General Appearance · Abnormal, NCS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination Week 54: General Appearance · Abnormal, CS	0 Participants	1 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: General Appearance · Normal	67 Participants	64 Participants	68 Participants	61 Participants
Change in Physical Examination Week 80: General Appearance · Abnormal, NCS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination Week 80: General Appearance · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 0: Head, Ears, Eyes, Nose, Throat, Neck · Normal	75 Participants	77 Participants	76 Participants	76 Participants
Change in Physical Examination Week 0: Head, Ears, Eyes, Nose, Throat, Neck · Abnormal, NCS	2 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination Week 0: Head, Ears, Eyes, Nose, Throat, Neck · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: Head, Ears, Eyes, Nose, Throat, Neck · Normal	66 Participants	65 Participants	66 Participants	66 Participants
Change in Physical Examination Week 54: Head, Ears, Eyes, Nose, Throat, Neck · Abnormal, NCS	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: Head, Ears, Eyes, Nose, Throat, Neck · Abnormal, CS	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: Head, Ears, Eyes, Nose, Throat, Neck · Normal	65 Participants	64 Participants	66 Participants	60 Participants
Change in Physical Examination Week 80: Head, Ears, Eyes, Nose, Throat, Neck · Abnormal, NCS	2 Participants	0 Participants	2 Participants	2 Participants
Change in Physical Examination Week 80: Head, Ears, Eyes, Nose, Throat, Neck · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 0: Respiratory System · Normal	77 Participants	77 Participants	76 Participants	77 Participants
Change in Physical Examination Week 0: Respiratory System · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 0: Respiratory System · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: Respiratory System · Normal	68 Participants	65 Participants	66 Participants	66 Participants
Change in Physical Examination Week 54: Respiratory System · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: Respiratory System · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: Respiratory System · Normal	67 Participants	64 Participants	68 Participants	61 Participants
Change in Physical Examination Week 80: Respiratory System · Abnormal, NCS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination Week 80: Respiratory System · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 0: Cardiovascular System · Normal	74 Participants	76 Participants	76 Participants	73 Participants
Change in Physical Examination Week 0: Cardiovascular System · Abnormal, NCS	3 Participants	1 Participants	0 Participants	4 Participants
Change in Physical Examination Week 0: Cardiovascular System · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: Cardiovascular System · Normal	67 Participants	65 Participants	65 Participants	66 Participants
Change in Physical Examination Week 54: Cardiovascular System · Abnormal, NCS	1 Participants	0 Participants	1 Participants	0 Participants
Change in Physical Examination Week 54: Cardiovascular System · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: Cardiovascular System · Normal	67 Participants	64 Participants	67 Participants	62 Participants
Change in Physical Examination Week 80: Cardiovascular System · Abnormal, NCS	0 Participants	0 Participants	1 Participants	0 Participants
Change in Physical Examination Week 80: Cardiovascular System · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 0: Gastrointestinal System incl. Mouth · Normal	75 Participants	76 Participants	76 Participants	76 Participants
Change in Physical Examination Week 0: Gastrointestinal System incl. Mouth · Abnormal, NCS	2 Participants	1 Participants	0 Participants	1 Participants
Change in Physical Examination Week 0: Gastrointestinal System incl. Mouth · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: Gastrointestinal System incl. Mouth · Normal	68 Participants	64 Participants	66 Participants	65 Participants
Change in Physical Examination Week 54: Gastrointestinal System incl. Mouth · Abnormal, NCS	0 Participants	1 Participants	0 Participants	1 Participants
Change in Physical Examination Week 54: Gastrointestinal System incl. Mouth · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: Gastrointestinal System incl. Mouth · Normal	67 Participants	63 Participants	68 Participants	61 Participants
Change in Physical Examination Week 80: Central and Peripheral Nervous System · Abnormal, NCS	1 Participants	1 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: Central and Peripheral Nervous System · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 0: Skin · Normal	70 Participants	75 Participants	69 Participants	74 Participants
Change in Physical Examination Week 0: Skin · Abnormal, NCS	6 Participants	2 Participants	7 Participants	3 Participants
Change in Physical Examination Week 0: Skin · Abnormal, CS	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: Skin · Normal	61 Participants	63 Participants	63 Participants	66 Participants
Change in Physical Examination Week 54: Skin · Abnormal, NCS	5 Participants	1 Participants	3 Participants	0 Participants
Change in Physical Examination Week 54: Skin · Abnormal, CS	2 Participants	1 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: Skin · Normal	61 Participants	62 Participants	65 Participants	62 Participants
Change in Physical Examination Week 80: Skin · Abnormal, NCS	6 Participants	2 Participants	3 Participants	0 Participants
Change in Physical Examination Week 80: Skin · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 0: Lymph Node Palpation · Normal	77 Participants	76 Participants	76 Participants	77 Participants
Change in Physical Examination Week 0: Lymph Node Palpation · Abnormal, NCS	0 Participants	1 Participants	0 Participants	0 Participants
Change in Physical Examination Week 0: Lymph Node Palpation · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: Lymph Node Palpation · Normal	68 Participants	65 Participants	66 Participants	64 Participants
Change in Physical Examination Week 54: Lymph Node Palpation · Abnormal, NCS	0 Participants	0 Participants	0 Participants	1 Participants
Change in Physical Examination Week 54: Lymph Node Palpation · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: Lymph Node Palpation · Normal	67 Participants	63 Participants	67 Participants	62 Participants
Change in Physical Examination Week 80: Lymph Node Palpation · Abnormal, NCS	0 Participants	0 Participants	1 Participants	0 Participants
Change in Physical Examination Week 80: Lymph Node Palpation · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 0: Thyroid Gland · Normal	77 Participants	76 Participants	76 Participants	75 Participants
Change in Physical Examination Week 0: Thyroid Gland · Abnormal, NCS	0 Participants	1 Participants	0 Participants	2 Participants
Change in Physical Examination Week 0: Thyroid Gland · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: Thyroid Gland · Normal	67 Participants	65 Participants	66 Participants	65 Participants
Change in Physical Examination Week 54: Thyroid Gland · Abnormal, NCS	1 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 54: Thyroid Gland · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: Thyroid Gland · Normal	67 Participants	64 Participants	68 Participants	62 Participants
Change in Physical Examination Week 80: Thyroid Gland · Abnormal, NCS	0 Participants	0 Participants	0 Participants	0 Participants
Change in Physical Examination Week 80: Thyroid Gland · Abnormal, CS	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

This outcome measure was applicable for NNC0114-0006 + Liraglutide treatment arm and NNC0114-0006 treatment arm. Participants was assessed for anti-NNC0114-0006 antibodies. Participant who reported anti-NNC0114-0006 antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-NNC0114-0006 antibodies at week 54 and week 80 are presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Occurrence of Anti-NNC0114-0006 Antibodies Week 0: Anti-NNC0114-0006 antibodies · Negative	68 Participants	62 Participants	—	—
Occurrence of Anti-NNC0114-0006 Antibodies Week 0: Anti-NNC0114-0006 antibodies · Positive	9 Participants	14 Participants	—	—
Occurrence of Anti-NNC0114-0006 Antibodies Week 0: Cross-reactivity · Negative	4 Participants	7 Participants	—	—
Occurrence of Anti-NNC0114-0006 Antibodies Week 0: Cross-reactivity · Positive	5 Participants	7 Participants	—	—
Occurrence of Anti-NNC0114-0006 Antibodies Week 54: Anti-NNC0114-0006 · Negative	68 Participants	62 Participants	—	—
Occurrence of Anti-NNC0114-0006 Antibodies Week 54: Anti-NNC0114-0006 · Positive	0 Participants	3 Participants	—	—
Occurrence of Anti-NNC0114-0006 Antibodies Week 54: Cross-reactivity · Negative	0 Participants	3 Participants	—	—
Occurrence of Anti-NNC0114-0006 Antibodies Week 54: Cross-reactivity · Positive	0 Participants	0 Participants	—	—
Occurrence of Anti-NNC0114-0006 Antibodies Week 80: Anti-NNC0114-0006 antibodies · Negative	65 Participants	60 Participants	—	—
Occurrence of Anti-NNC0114-0006 Antibodies Week 80: Anti-NNC0114-0006 antibodies · Positive	2 Participants	4 Participants	—	—
Occurrence of Anti-NNC0114-0006 Antibodies Week 80: Cross-reactivity · Negative	1 Participants	2 Participants	—	—
Occurrence of Anti-NNC0114-0006 Antibodies Week 80: Cross-reactivity · Positive	1 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The SAS included all participants who received at least one dose of the investigational product or comparator. Number analyzed = participants with available data.

This outcome measure is applicable for NNC0114-0006 + Liraglutide treatment arm and Liraglutide treatment arm. Participants was assessed for anti-liraglutide antibodies. Participant who reported anti-liraglutide antibodies were further analyzed for cross-reactivity. Number of participants who measured with anti-liraglutide antibodies at week 54 and week 80 are presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=76 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Occurrence of Anti-liraglutide Antibodies Week 0: Anti-Liraglutide antibodies · Negative	77 Participants	75 Participants	—	—
Occurrence of Anti-liraglutide Antibodies Week 0: Anti-Liraglutide antibodies · Positive	0 Participants	0 Participants	—	—
Occurrence of Anti-liraglutide Antibodies Week 0: Cross-reactivity to native GLP-1 · Negative	0 Participants	0 Participants	—	—
Occurrence of Anti-liraglutide Antibodies Week 0: Cross-reactivity to native GLP-1 · Positive	0 Participants	0 Participants	—	—
Occurrence of Anti-liraglutide Antibodies Week 54: Anti-Liraglutide antibodies · Negative	67 Participants	65 Participants	—	—
Occurrence of Anti-liraglutide Antibodies Week 54: Anti-Liraglutide antibodies · Positive	1 Participants	2 Participants	—	—
Occurrence of Anti-liraglutide Antibodies Week 54: Cross-reactivity to native GLP-1 · Negative	1 Participants	1 Participants	—	—
Occurrence of Anti-liraglutide Antibodies Week 54: Cross-reactivity to native GLP-1 · Positive	0 Participants	1 Participants	—	—
Occurrence of Anti-liraglutide Antibodies Week 80: Anti-Liraglutide antibodies · Negative	67 Participants	66 Participants	—	—
Occurrence of Anti-liraglutide Antibodies Week 80: Anti-Liraglutide antibodies · Positive	0 Participants	2 Participants	—	—
Occurrence of Anti-liraglutide Antibodies Week 80: Cross-reactivity to native GLP-1 · Negative	0 Participants	0 Participants	—	—
Occurrence of Anti-liraglutide Antibodies Week 80: Cross-reactivity to native GLP-1 · Positive	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

The total daily insulin dose was derived as the average of the doses reported on the three days prior to the visit. Change in daily total insulin dose from baseline (week 0) after 54 weeks of treatment and week 80 are presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Insulin Dose Change from week 0 to week 54	-0.05 Units per kilograms Standard Deviation 0.18	0.02 Units per kilograms Standard Deviation 0.18	0.01 Units per kilograms Standard Deviation 0.23	0.09 Units per kilograms Standard Deviation 0.19
Change in Insulin Dose Change from week 0 to week 80	0.10 Units per kilograms Standard Deviation 0.20	0.05 Units per kilograms Standard Deviation 0.19	0.11 Units per kilograms Standard Deviation 0.22	0.12 Units per kilograms Standard Deviation 0.18

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

The number of insulin injections was derived as the average of the reported number on the three days prior to the visit. The change in number of insulin injections per day (count) from baseline (week 0) after 54 weeks of treatment and week 80 are presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Number of Insulin Injections Change from week 0 to week 54	-0.3 Injections per day Standard Deviation 1.5	-0.1 Injections per day Standard Deviation 1.2	-0.5 Injections per day Standard Deviation 1.7	0.2 Injections per day Standard Deviation 1.4
Change in Number of Insulin Injections Change from week 0 to week 80	0.2 Injections per day Standard Deviation 1.5	-0.3 Injections per day Standard Deviation 1.3	-0.2 Injections per day Standard Deviation 1.5	0.2 Injections per day Standard Deviation 1.3

SECONDARY outcome

Timeframe: (Week 0 to week 54) and (week 0 to week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

The number of weeks off bolus insulin after 54 weeks of treatment and week 80 are presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Number of Weeks Off Bolus Insulin Week 0 to week 80	14 Weeks Standard Deviation 25	9 Weeks Standard Deviation 20	12 Weeks Standard Deviation 24	6 Weeks Standard Deviation 14
Number of Weeks Off Bolus Insulin Week 0 to week 54	10 Weeks Standard Deviation 18	5 Weeks Standard Deviation 14	9 Weeks Standard Deviation 18	4 Weeks Standard Deviation 11

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Change in glycosylated haemoglobin (HbA1c) is evaluated from baseline (week 0) to weeks 54 and 80.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in HbA1c Change from week 0 to week 54	-0.7 Percentage point of HbA1c Standard Deviation 1.9	-0.5 Percentage point of HbA1c Standard Deviation 1.4	-0.3 Percentage point of HbA1c Standard Deviation 1.5	-0.3 Percentage point of HbA1c Standard Deviation 1.9
Change in HbA1c Change from week 0 to week 80	-0.1 Percentage point of HbA1c Standard Deviation 1.6	-0.2 Percentage point of HbA1c Standard Deviation 1.5	0.5 Percentage point of HbA1c Standard Deviation 2.1	-0.4 Percentage point of HbA1c Standard Deviation 1.8

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Change in fasting plasma glucose is evaluated from baseline (week 0) to weeks 54 and 80.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Fasting Plasma Glucose Change from week 0 to week 54	0.5 mmol/L Standard Deviation 3.2	0.2 mmol/L Standard Deviation 2.4	-0.3 mmol/L Standard Deviation 3.1	0.5 mmol/L Standard Deviation 2.4
Change in Fasting Plasma Glucose Change from week 0 to week 80	1.1 mmol/L Standard Deviation 3.3	0.3 mmol/L Standard Deviation 2.4	0.2 mmol/L Standard Deviation 4.0	1.0 mmol/L Standard Deviation 2.4

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Change in fasting C-peptide (measured in nanomole per liter \[nmol/L\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Fasting C-peptide- Ratio to Baseline Ratio from week 0 to week 54	1.01 Ratio of C-peptide Geometric Coefficient of Variation 76.8	0.70 Ratio of C-peptide Geometric Coefficient of Variation 71.1	0.65 Ratio of C-peptide Geometric Coefficient of Variation 102.4	0.66 Ratio of C-peptide Geometric Coefficient of Variation 116.3
Change in Fasting C-peptide- Ratio to Baseline Ratio from week 0 to week 80	0.58 Ratio of C-peptide Geometric Coefficient of Variation 112.9	0.53 Ratio of C-peptide Geometric Coefficient of Variation 106.2	0.42 Ratio of C-peptide Geometric Coefficient of Variation 132.5	0.54 Ratio of C-peptide Geometric Coefficient of Variation 154.4

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Change in fasting glucagon (measured in picogram per milliliter \[pg/mL\]) from baseline (week 0) to weeks 54 and 80 is presented as ratio to baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Fasting Glucagon- Ratio to Baseline Ratio from week 0 to week 54	1.01 Ratio of glucagon Geometric Coefficient of Variation 32.1	0.95 Ratio of glucagon Geometric Coefficient of Variation 32.5	0.96 Ratio of glucagon Geometric Coefficient of Variation 31.3	1.00 Ratio of glucagon Geometric Coefficient of Variation 31.4
Change in Fasting Glucagon- Ratio to Baseline Ratio from week 0 to week 80	0.89 Ratio of glucagon Geometric Coefficient of Variation 36.2	0.85 Ratio of glucagon Geometric Coefficient of Variation 30.7	0.96 Ratio of glucagon Geometric Coefficient of Variation 32.8	0.93 Ratio of glucagon Geometric Coefficient of Variation 37.8

SECONDARY outcome

Timeframe: Week 54 and Week 80

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. 7-point SMPG profile values are presented for week 54 and week 80.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
7-point SMPG Profiles Week 80: Before dinner	6.5 mmol/L Standard Deviation 2.2	6.7 mmol/L Standard Deviation 2.9	7.6 mmol/L Standard Deviation 4.1	6.5 mmol/L Standard Deviation 1.6
7-point SMPG Profiles Week 80: 90 minutes after start of dinner	7.6 mmol/L Standard Deviation 2.5	7.0 mmol/L Standard Deviation 2.1	9.0 mmol/L Standard Deviation 5.0	7.6 mmol/L Standard Deviation 2.5
7-point SMPG Profiles Week 54: Before breakfast	6.8 mmol/L Standard Deviation 3.4	6.8 mmol/L Standard Deviation 2.7	6.4 mmol/L Standard Deviation 2.2	6.3 mmol/L Standard Deviation 1.4
7-point SMPG Profiles Week 54: 90 minutes after start of breakfast	8.9 mmol/L Standard Deviation 3.7	7.5 mmol/L Standard Deviation 2.4	7.4 mmol/L Standard Deviation 2.1	7.6 mmol/L Standard Deviation 2.4
7-point SMPG Profiles Week 54: Before lunch	5.5 mmol/L Standard Deviation 1.8	6.4 mmol/L Standard Deviation 2.3	6.1 mmol/L Standard Deviation 1.8	6.0 mmol/L Standard Deviation 1.6
7-point SMPG Profiles Week 54: 90 minutes after start of lunch	8.2 mmol/L Standard Deviation 2.6	7.5 mmol/L Standard Deviation 2.7	7.8 mmol/L Standard Deviation 2.4	7.7 mmol/L Standard Deviation 2.0
7-point SMPG Profiles Week 54: Before dinner	6.5 mmol/L Standard Deviation 1.9	6.5 mmol/L Standard Deviation 2.5	6.6 mmol/L Standard Deviation 2.2	6.1 mmol/L Standard Deviation 1.7
7-point SMPG Profiles Week 54: 90 minutes after start of dinner	8.2 mmol/L Standard Deviation 3.4	7.0 mmol/L Standard Deviation 2.5	7.2 mmol/L Standard Deviation 2.3	6.8 mmol/L Standard Deviation 1.9
7-point SMPG Profiles Week 54: Bedtime	7.8 mmol/L Standard Deviation 3.9	7.4 mmol/L Standard Deviation 2.6	7.5 mmol/L Standard Deviation 2.5	7.2 mmol/L Standard Deviation 2.1
7-point SMPG Profiles Week 80: Before breakfast	6.5 mmol/L Standard Deviation 1.7	6.4 mmol/L Standard Deviation 2.0	7.2 mmol/L Standard Deviation 2.7	6.8 mmol/L Standard Deviation 2.0
7-point SMPG Profiles Week 80: 90 minutes after start of breakfast	8.5 mmol/L Standard Deviation 2.8	7.2 mmol/L Standard Deviation 3.0	8.3 mmol/L Standard Deviation 3.7	7.5 mmol/L Standard Deviation 2.7
7-point SMPG Profiles Week 80: Before lunch	6.2 mmol/L Standard Deviation 2.2	6.2 mmol/L Standard Deviation 2.0	6.9 mmol/L Standard Deviation 3.3	6.1 mmol/L Standard Deviation 1.8
7-point SMPG Profiles Week 80: 90 minutes after start of lunch	7.8 mmol/L Standard Deviation 2.6	7.6 mmol/L Standard Deviation 2.7	8.5 mmol/L Standard Deviation 4.5	8.0 mmol/L Standard Deviation 3.0
7-point SMPG Profiles Week 80: Bedtime	7.8 mmol/L Standard Deviation 3.0	6.6 mmol/L Standard Deviation 1.8	7.8 mmol/L Standard Deviation 4.4	7.4 mmol/L Standard Deviation 2.2

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point SMPG postprandial glucose /prandial increment (breakfast, lunch and dinner) value are presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner Change from week 0 to week 54: Breakfast	1.3 mmol/L Standard Deviation 4.0	0.4 mmol/L Standard Deviation 3.0	-0.1 mmol/L Standard Deviation 3.8	-0.6 mmol/L Standard Deviation 2.4
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner Change from week 0 to week 80: Breakfast	1.9 mmol/L Standard Deviation 4.2	0.5 mmol/L Standard Deviation 4.0	-0.1 mmol/L Standard Deviation 4.5	-0.5 mmol/L Standard Deviation 4.5
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner Change from week 0 to week 54: Lunch	0.9 mmol/L Standard Deviation 4.5	0.5 mmol/L Standard Deviation 3.4	1.5 mmol/L Standard Deviation 2.9	0.7 mmol/L Standard Deviation 2.7
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner Change from week 0 to week 80: Lunch	0.0 mmol/L Standard Deviation 4.5	0.1 mmol/L Standard Deviation 3.0	1.0 mmol/L Standard Deviation 3.5	0.8 mmol/L Standard Deviation 4.5
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner Change from week 0 to week 54: Dinner	0.1 mmol/L Standard Deviation 4.5	1.1 mmol/L Standard Deviation 4.0	-0.8 mmol/L Standard Deviation 4.7	-0.3 mmol/L Standard Deviation 3.1
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment: Breakfast, Lunch, Dinner Change from week 0 to week 80: Dinner	0.5 mmol/L Standard Deviation 5.0	0.5 mmol/L Standard Deviation 3.4	-0.4 mmol/L Standard Deviation 4.3	-0.4 mmol/L Standard Deviation 3.2

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in 7-point self-measured plasma glucose (SMPG) postprandial glucose /prandial increment (average over the three meals) value is presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals) Change from week 0 to week 54	0.9 mmol/L Standard Deviation 2.3	0.6 mmol/L Standard Deviation 2.2	0.2 mmol/L Standard Deviation 2.0	-0.1 mmol/L Standard Deviation 2.0
Change in 7- Points Self-measured Plasma Glucose (SMPG) Postprandial Glucose /Prandial Increment (Average Over the Three Meals) Change from week 0 to week 80	0.8 mmol/L Standard Deviation 2.6	0.4 mmol/L Standard Deviation 2.2	0.0 mmol/L Standard Deviation 2.5	-0.0 mmol/L Standard Deviation 2.9

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime. Change from baseline (week 0) to week 54 and week 80 in mean of 7-point profiles value is presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Mean of 7-point Profiles Change from week 0 to week 54	0.5 mmol/L Standard Deviation 2.0	0.3 mmol/L Standard Deviation 2.4	-0.1 mmol/L Standard Deviation 1.9	0.0 mmol/L Standard Deviation 1.2
Change in Mean of 7-point Profiles Change from week 0 to week 80	0.1 mmol/L Standard Deviation 2.1	0.0 mmol/L Standard Deviation 2.3	0.7 mmol/L Standard Deviation 1.6	0.3 mmol/L Standard Deviation 1.7

SECONDARY outcome

Timeframe: Week 54 and week 80

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Before breakfast 7-point self-measured plasma glucose (SMPG) profile values are presented at week 54 and week 80.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG) Week 54	6.8 mmol/L Standard Deviation 3.4	6.8 mmol/L Standard Deviation 2.7	6.4 mmol/L Standard Deviation 2.2	6.3 mmol/L Standard Deviation 1.4
Before Breakfast 7- Points Self Measured Plasma Glucose (SMPG) Week 80	6.5 mmol/L Standard Deviation 1.7	6.4 mmol/L Standard Deviation 2.0	7.2 mmol/L Standard Deviation 2.7	6.8 mmol/L Standard Deviation 2.0

SECONDARY outcome

Timeframe: Pre-dose and 1 hour post-dose during week 48 to week 54

Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

AUCtau, NNC0114-0006 was derived as the area under the concentration-time curve using the linear trapezoidal technique based on observed values and actual measurement times between 0 and 6 weeks (after the last dose). This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=17 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=16 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Area Under the NNC0114-0006 Concentration-time Curve Over a Dosing Interval at Steady State (AUCtau, NNC0114-0006)	3969 daymicrogram per milliliter (dayug/mL) Geometric Coefficient of Variation 17.9	4115 daymicrogram per milliliter (dayug/mL) Geometric Coefficient of Variation 23.1	—	—

SECONDARY outcome

Timeframe: Pre-dose and 1 hour post-dose during week 48 to week 80

Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Terminal half life was calculated as log(2)/λz. The terminal rate constant λz was determined through linear regression with the logarithm to concentration as the response variable and actual measurement time as the explanatory variable. Valid observations from the terminal part of the curve, which is approximately linear, were used for the determination. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=17 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=16 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Terminal Half-life (t½) After Last Dose of NNC0114-0006	22.3 Days Geometric Coefficient of Variation 17.9	22.2 Days Geometric Coefficient of Variation 16.5	—	—

SECONDARY outcome

Timeframe: Pre-dose and 1 hour post-dose during week 48 to week 80

Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

The apparent volume of distribution of NNC0114-0006 at steady-state was calculated as mean residence time of (MRT) of NNC0114-0006 multiplied by clearance of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=17 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=16 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Apparent Volume of Distribution of NNC0114-0006 at Steadystate (Vss, NNC0114-0006)	83.7 Milliliters per kilogram (mL/kg) Geometric Coefficient of Variation 23.1	79.3 Milliliters per kilogram (mL/kg) Geometric Coefficient of Variation 17.6	—	—

SECONDARY outcome

Timeframe: Pre-dose and 1 hour post-dose during week 48 to week 54

Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Clearance of NNC0114-0006 at steady state was calculated as dose/AUCtau, NNC0114-0006. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=17 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=16 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Clearance of NNC0114-0006 at Steady State (CLss, NNC0114-0006)	3.02 (Milliliters/day)/kilogram ([mL/day]/kg) Geometric Coefficient of Variation 17.9	2.92 (Milliliters/day)/kilogram ([mL/day]/kg) Geometric Coefficient of Variation 23.1	—	—

SECONDARY outcome

Timeframe: Pre-dose and 1 hour post-dose during week 48 to week 80

Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms. Mean residence time of NNC0114-0006 is presented.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=17 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=16 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Mean Residence Time of NNC0114-0006 (MRT, NNC0114-0006)	27.7 Days Geometric Coefficient of Variation 24.5	27.2 Days Geometric Coefficient of Variation 22.6	—	—

SECONDARY outcome

Timeframe: Pre-dose and 1 hour post-dose during (week 0 to week 6) and (week 48 to week 54)

Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Accumulation ratio of NNC114-0006 was defined as AUC48-54 weeks/AUC0-6 weeks. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=16 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=16 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Accumulation Ratio of NNC114-0006 (RA,AUC, NNC0114-0006)	1.24 Ratio of AUC Geometric Coefficient of Variation 17.8	1.26 Ratio of AUC Geometric Coefficient of Variation 17.4	—	—

SECONDARY outcome

Timeframe: Week 48 (predose)

Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

Ctrough of NNC0114-0006 was defined as concentration prior to dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=17 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=16 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Observed NNC0114-0006 Concentration Prior to Dosing of NNC0114-0006 at Steady State (Ctrough, NNC0114-0006)	34.7 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 42.3	36.7 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 36.8	—	—

SECONDARY outcome

Timeframe: Week 48 (1 hour post-dose)

Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

C1h, NNC0114-0006 was defined as concentration of NNC0114-0006 at 1 hour after dosing of NNC0114-0006 at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and NNC0114-0006 treatment arms.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=14 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=15 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Observed NNC0114-0006 Concentration 1 Hour After Dosing of NNC0114-0006 at Steady State (C1h, NNC0114-0006)	298.6 ug/mL Geometric Coefficient of Variation 16.8	282.6 ug/mL Geometric Coefficient of Variation 56.4	—	—

SECONDARY outcome

Timeframe: Week 54 (post-dose)

Population: The PK analysis set comprised all randomized participants with at least one valid PK measurement. Overall number of participants analyzed = participants with available data.

C liraglutide was defined as the liraglutide concentration at steady state. This outcome measure was applicable for NNC0114-0006 + Liraglutide and Liraglutide treatment arms.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=17 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=19 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Liraglutide Concentration at Steady State (C Liraglutide)	16287 picomole per liter (pmol/L) Geometric Coefficient of Variation 41.7	15920 picomole per liter (pmol/L) Geometric Coefficient of Variation 66.0	—	—

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Autoantibodies Against Glutamic Acid Decarboxylase (GAD) Week 0 · Negative	3 Participants	1 Participants	5 Participants	3 Participants
Autoantibodies Against Glutamic Acid Decarboxylase (GAD) Week 0 · Positive	74 Participants	76 Participants	71 Participants	74 Participants
Autoantibodies Against Glutamic Acid Decarboxylase (GAD) Week 54 · Negative	5 Participants	4 Participants	4 Participants	3 Participants
Autoantibodies Against Glutamic Acid Decarboxylase (GAD) Week 54 · Positive	62 Participants	61 Participants	64 Participants	63 Participants
Autoantibodies Against Glutamic Acid Decarboxylase (GAD) Week 80 · Negative	4 Participants	2 Participants	5 Participants	1 Participants
Autoantibodies Against Glutamic Acid Decarboxylase (GAD) Week 80 · Positive	61 Participants	62 Participants	63 Participants	61 Participants

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Participants were analyzed for autoantibodies against Zinc-transporter 8 (ZnT8) and were categorized as negative and positive.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Autoantibodies Against Zinc-transporter 8 (ZnT8) Week 0 · Negative	29 Participants	30 Participants	30 Participants	36 Participants
Autoantibodies Against Zinc-transporter 8 (ZnT8) Week 0 · Positive	48 Participants	47 Participants	46 Participants	41 Participants
Autoantibodies Against Zinc-transporter 8 (ZnT8) Week 54 · Negative	26 Participants	28 Participants	27 Participants	33 Participants
Autoantibodies Against Zinc-transporter 8 (ZnT8) Week 54 · Positive	42 Participants	37 Participants	41 Participants	33 Participants
Autoantibodies Against Zinc-transporter 8 (ZnT8) Week 80 · Negative	23 Participants	30 Participants	31 Participants	33 Participants
Autoantibodies Against Zinc-transporter 8 (ZnT8) Week 80 · Positive	42 Participants	34 Participants	37 Participants	29 Participants

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Participants were analyzed for autoantibodies against Islet antigen-2 (IA2) and were categorized as negative and positive.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Autoantibodies Against Islet Antigen-2 (IA2) Week 0 · Negative	38 Participants	37 Participants	31 Participants	45 Participants
Autoantibodies Against Islet Antigen-2 (IA2) Week 0 · Positive	39 Participants	40 Participants	45 Participants	32 Participants
Autoantibodies Against Islet Antigen-2 (IA2) Week 54 · Negative	35 Participants	33 Participants	28 Participants	38 Participants
Autoantibodies Against Islet Antigen-2 (IA2) Week 54 · Positive	33 Participants	32 Participants	40 Participants	28 Participants
Autoantibodies Against Islet Antigen-2 (IA2) Week 80 · Negative	32 Participants	38 Participants	29 Participants	35 Participants
Autoantibodies Against Islet Antigen-2 (IA2) Week 80 · Positive	33 Participants	26 Participants	39 Participants	27 Participants

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Participants were analyzed for autoantibodies against Insulin autoantibodies (IAA) and were categorized as negative and positive.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Autoantibodies Against Insulin Autoantibodies (IAA) Week 0 · Negative	35 Participants	28 Participants	26 Participants	36 Participants
Autoantibodies Against Insulin Autoantibodies (IAA) Week 0 · Positive	42 Participants	48 Participants	49 Participants	40 Participants
Autoantibodies Against Insulin Autoantibodies (IAA) Week 54 · Negative	30 Participants	28 Participants	22 Participants	11 Participants
Autoantibodies Against Insulin Autoantibodies (IAA) Week 54 · Positive	38 Participants	37 Participants	46 Participants	55 Participants
Autoantibodies Against Insulin Autoantibodies (IAA) Week 80 · Negative	18 Participants	24 Participants	13 Participants	15 Participants
Autoantibodies Against Insulin Autoantibodies (IAA) Week 80 · Positive	48 Participants	40 Participants	55 Participants	47 Participants

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

IL-21 is evaluated at baseline (week 0), week 54 and week 80.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biomarker: Total Interleukin-21 (IL-21) Week 0	28.8 picogram per milliliter Standard Deviation 10.2	31.1 picogram per milliliter Standard Deviation 10.8	30.9 picogram per milliliter Standard Deviation 10.7	30.2 picogram per milliliter Standard Deviation 10.2
Change in Biomarker: Total Interleukin-21 (IL-21) Week 54	3993.5 picogram per milliliter Standard Deviation 2145.4	4368.2 picogram per milliliter Standard Deviation 2374.9	25.0 picogram per milliliter Standard Deviation 0.0	34.1 picogram per milliliter Standard Deviation 68.1
Change in Biomarker: Total Interleukin-21 (IL-21) Week 80	540.9 picogram per milliliter Standard Deviation 495.3	674.1 picogram per milliliter Standard Deviation 648.1	28.0 picogram per milliliter Standard Deviation 8.2	30.7 picogram per milliliter Standard Deviation 17.2

SECONDARY outcome

Timeframe: Week 0, week 54 and week 80

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Serum vitamin D is evaluated at baseline (week 0), week 54 and week 80.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) Week 0	123 picomole per liter Standard Deviation 30	122 picomole per liter Standard Deviation 39	122 picomole per liter Standard Deviation 29	120 picomole per liter Standard Deviation 33
Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) Week 54	117 picomole per liter Standard Deviation 31	125 picomole per liter Standard Deviation 36	113 picomole per liter Standard Deviation 30	119 picomole per liter Standard Deviation 32
Change in Biomarker: Serum Vitamin D (1,25 Dehydroxy-calciferol) Week 80	119 picomole per liter Standard Deviation 41	124 picomole per liter Standard Deviation 49	121 picomole per liter Standard Deviation 38	115 picomole per liter Standard Deviation 33

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

SF-36v2™ questionnaire measured the HRQoL on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. Change from baseline (week 0) to week 54 and week 80 in SF-36 score is presented.The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicate an improvement since baseline.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Short Form 36 Health Survey (SF-36) Week 54: General Health Perception	-1.1 Score on a scale Standard Deviation 7.1	-0.3 Score on a scale Standard Deviation 8.4	-1.6 Score on a scale Standard Deviation 7.3	-1.0 Score on a scale Standard Deviation 7.1
Change in Short Form 36 Health Survey (SF-36) Week 80: Bodily Pain	0.8 Score on a scale Standard Deviation 7.8	-1.4 Score on a scale Standard Deviation 7.0	-0.5 Score on a scale Standard Deviation 6.4	0.8 Score on a scale Standard Deviation 10.2
Change in Short Form 36 Health Survey (SF-36) Week 80: General Health Perception	-0.9 Score on a scale Standard Deviation 7.2	0.6 Score on a scale Standard Deviation 9.0	-1.7 Score on a scale Standard Deviation 7.9	-1.8 Score on a scale Standard Deviation 8.6
Change in Short Form 36 Health Survey (SF-36) Week 54: Mental Component Sum	0.5 Score on a scale Standard Deviation 9.4	0.6 Score on a scale Standard Deviation 9.3	-2.1 Score on a scale Standard Deviation 9.0	-1.3 Score on a scale Standard Deviation 7.6
Change in Short Form 36 Health Survey (SF-36) Week 80: Mental Component Sum	1.7 Score on a scale Standard Deviation 9.8	-0.4 Score on a scale Standard Deviation 8.9	-2.4 Score on a scale Standard Deviation 9.6	-0.7 Score on a scale Standard Deviation 8.7
Change in Short Form 36 Health Survey (SF-36) week 54: Mental Health	0.7 Score on a scale Standard Deviation 8.4	0.6 Score on a scale Standard Deviation 7.9	-1.5 Score on a scale Standard Deviation 8.6	-1.3 Score on a scale Standard Deviation 6.9
Change in Short Form 36 Health Survey (SF-36) Week 80: Mental Health	1.5 Score on a scale Standard Deviation 8.6	-0.2 Score on a scale Standard Deviation 8.0	-1.5 Score on a scale Standard Deviation 9.0	-0.7 Score on a scale Standard Deviation 7.6
Change in Short Form 36 Health Survey (SF-36) Week 54: Physical Component Sum	-0.4 Score on a scale Standard Deviation 4.2	-0.4 Score on a scale Standard Deviation 5.3	-0.1 Score on a scale Standard Deviation 3.8	0.3 Score on a scale Standard Deviation 5.7
Change in Short Form 36 Health Survey (SF-36) Week 80: Physical Component Sum	-0.1 Score on a scale Standard Deviation 3.9	0.5 Score on a scale Standard Deviation 5.4	0.0 Score on a scale Standard Deviation 4.3	0.0 Score on a scale Standard Deviation 6.9
Change in Short Form 36 Health Survey (SF-36) Week 54: Physical Functioning	0.6 Score on a scale Standard Deviation 2.5	0.9 Score on a scale Standard Deviation 4.4	0.0 Score on a scale Standard Deviation 2.6	0.3 Score on a scale Standard Deviation 5.8
Change in Short Form 36 Health Survey (SF-36) Week 80: Physical Functioning	0.5 Score on a scale Standard Deviation 2.9	1.1 Score on a scale Standard Deviation 4.6	-0.1 Score on a scale Standard Deviation 2.4	0.1 Score on a scale Standard Deviation 6.4
Change in Short Form 36 Health Survey (SF-36) Week 54:Lim Emotion Prob	0.3 Score on a scale Standard Deviation 10.7	0.5 Score on a scale Standard Deviation 8.9	-1.4 Score on a scale Standard Deviation 9.0	-0.1 Score on a scale Standard Deviation 8.5
Change in Short Form 36 Health Survey (SF-36) Week 80: Lim Emotion Prob	1.2 Score on a scale Standard Deviation 10.8	-0.1 Score on a scale Standard Deviation 9.8	-2.2 Score on a scale Standard Deviation 9.4	0.0 Score on a scale Standard Deviation 8.3
Change in Short Form 36 Health Survey (SF-36) Week 54: Lim. Phy Health	0.3 Score on a scale Standard Deviation 5.8	0.7 Score on a scale Standard Deviation 6.9	-0.6 Score on a scale Standard Deviation 5.7	-0.2 Score on a scale Standard Deviation 6.9
Change in Short Form 36 Health Survey (SF-36) Week 80: Lim. Phy Health	0.8 Score on a scale Standard Deviation 6.4	0.9 Score on a scale Standard Deviation 7.0	-0.2 Score on a scale Standard Deviation 5.2	0.0 Score on a scale Standard Deviation 7.3
Change in Short Form 36 Health Survey (SF-36) Week 54: Social Functioning	0.8 Score on a scale Standard Deviation 10.3	0.1 Score on a scale Standard Deviation 10.0	-1.4 Score on a scale Standard Deviation 7.4	0.0 Score on a scale Standard Deviation 8.5
Change in Short Form 36 Health Survey (SF-36) Week 80: Social Functioning	2.3 Score on a scale Standard Deviation 9.9	1.0 Score on a scale Standard Deviation 8.3	-1.2 Score on a scale Standard Deviation 7.3	-0.4 Score on a scale Standard Deviation 8.4
Change in Short Form 36 Health Survey (SF-36) Week 54: Vitality	-0.5 Score on a scale Standard Deviation 8.2	0.5 Score on a scale Standard Deviation 7.9	-2.2 Score on a scale Standard Deviation 5.9	-2.3 Score on a scale Standard Deviation 6.9
Change in Short Form 36 Health Survey (SF-36) Week 80: Vitality	0.5 Score on a scale Standard Deviation 7.9	-1.4 Score on a scale Standard Deviation 6.9	-2.2 Score on a scale Standard Deviation 7.1	-0.7 Score on a scale Standard Deviation 6.9
Change in Short Form 36 Health Survey (SF-36) Week 54: Bodily pain	-0.8 Score on a scale Standard Deviation 8.5	-2.2 Score on a scale Standard Deviation 7.6	0.1 Score on a scale Standard Deviation 5.2	0.6 Score on a scale Standard Deviation 9.1

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Treatment Benefits and Barriers (ETBB) questionnaire measured diabetes-specific health beliefs on 2 categories: Total Score for Perceived Barriers and Perceived Benefits. The measurement of perceived benefits of, and barriers to, treatment was achieved by creating a pool 28 statements each with a 7-point scale ranging from strongly agree (6) to strongly disagree (0). ETBB benefits score was calculated using the responses from questions 1, 4, 7, 8, 10, and 12 and ETBB barriers score was calculated using the responses from questions 2, 3, 5, 6, 9, and 11. Both was calculated as the sum of responses divided by number of responses received multiplied by the maximum number of responses. Based on the responses used the maximum responses available was 6. The higher score indicates more perceived benefits or more perceived barrier.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Experience of Treatment Benefits and Barriers (ETBB) Week 54: Total Score for Perceived Barriers	-1.2 score on a scale Standard Deviation 8.3	-1.8 score on a scale Standard Deviation 7.7	-0.2 score on a scale Standard Deviation 8.2	-0.3 score on a scale Standard Deviation 6.3
Change in Experience of Treatment Benefits and Barriers (ETBB) Week 80: Total Score for Perceived Barriers	-2.0 score on a scale Standard Deviation 7.8	-2.0 score on a scale Standard Deviation 7.5	-0.1 score on a scale Standard Deviation 6.7	0.1 score on a scale Standard Deviation 8.3
Change in Experience of Treatment Benefits and Barriers (ETBB) Week 54: Total Score for Perceived Benefits	0.6 score on a scale Standard Deviation 5.6	1.1 score on a scale Standard Deviation 4.2	0.2 score on a scale Standard Deviation 5.7	-0.5 score on a scale Standard Deviation 6.3
Change in Experience of Treatment Benefits and Barriers (ETBB) Week 80: Total Score for Perceived Benefits	0.1 score on a scale Standard Deviation 5.8	1.1 score on a scale Standard Deviation 4.8	1.3 score on a scale Standard Deviation 6.2	-0.4 score on a scale Standard Deviation 5.1

SECONDARY outcome

Timeframe: (Week 0, week 54) and (week 0, week 80)

Population: The FAS included all randomised participants. Number analyzed = participants with available data.

Change from baseline (week 0) in DTSQ is evaluated at week 54 and 80. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher score indicates a higher level of glycaemia/treatment satisfaction.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Week 54: Perceived frequency of hyperglycaemia	0.6 Score on a scale Standard Deviation 1.9	0.0 Score on a scale Standard Deviation 1.5	0.0 Score on a scale Standard Deviation 1.9	0.5 Score on a scale Standard Deviation 1.7
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Week 80: Perceived frequency of hyperglycaemia	0.9 Score on a scale Standard Deviation 1.8	0.5 Score on a scale Standard Deviation 1.8	0.6 Score on a scale Standard Deviation 2.0	0.7 Score on a scale Standard Deviation 1.9
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Week 54: Perceived frequency of hypoglycaemia	-0.7 Score on a scale Standard Deviation 2.1	-0.6 Score on a scale Standard Deviation 1.6	-0.4 Score on a scale Standard Deviation 2.1	-0.2 Score on a scale Standard Deviation 1.5
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Week 80: Perceived frequency of hypoglycaemia	-0.9 Score on a scale Standard Deviation 1.8	-0.3 Score on a scale Standard Deviation 1.7	-0.4 Score on a scale Standard Deviation 1.8	-0.1 Score on a scale Standard Deviation 1.5
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Week 54: Treatment satisfaction	1.5 Score on a scale Standard Deviation 4.8	0.9 Score on a scale Standard Deviation 5.2	1.3 Score on a scale Standard Deviation 4.8	0.2 Score on a scale Standard Deviation 5.5
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Week 80: Treatment satisfaction	1.3 Score on a scale Standard Deviation 6.1	1.2 Score on a scale Standard Deviation 5.7	0.0 Score on a scale Standard Deviation 5.1	0.2 Score on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: 0 - 4 hours post-dose on week 0 and week 80

Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a mixed meal tolerance test (MMTT) stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as Nano moles\*hour per liter (nmol\*h/L).

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=63 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=64 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=62 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=58 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 80 Relative to Baseline	0.566 Ratio of AUC Geometric Coefficient of Variation 71.3	0.598 Ratio of AUC Geometric Coefficient of Variation 70.2	0.373 Ratio of AUC Geometric Coefficient of Variation 115.8	0.571 Ratio of AUC Geometric Coefficient of Variation 100.9

SECONDARY outcome

Timeframe: 0-2 hours post-dose on week 0 and week 80

Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. AUC of C-peptide was measured as 'nmol\*h/L'.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=63 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=64 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=62 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=58 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
AUC0-2h of C-peptide at Week 80 Relative to Baseline	0.590 Ratio of AUC Geometric Coefficient of Variation 74.5	0.619 Ratio of AUC Geometric Coefficient of Variation 71.2	0.370 Ratio of AUC Geometric Coefficient of Variation 111.5	0.540 Ratio of AUC Geometric Coefficient of Variation 120.6

SECONDARY outcome

Timeframe: 0-4 hours post-dose on week 0 and week 80

Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Maximum observed concentration (Cmax) of a MMTT stimulated C-peptide at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as nanomoles per liter (nmol/L).

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=63 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=64 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=62 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=58 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Cmax of C-peptide at Week 80 Relative to Baseline	0.580 Ratio of Cmax Geometric Coefficient of Variation 74.8	0.592 Ratio of Cmax Geometric Coefficient of Variation 76.8	0.389 Ratio of Cmax Geometric Coefficient of Variation 109.0	0.568 Ratio of Cmax Geometric Coefficient of Variation 97.7

SECONDARY outcome

Timeframe: 0 - 4 hours post-dose on week 0 and week 80

Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Area under the concentration-time curve, from 0 to 4 hours (AUC0-4h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as Milli moles\*hour per liter (mmol\*h/L).

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=63 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=64 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=63 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=58 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
AUC0-4h of Glucose at Week 80 Relative to Baseline	1.129 Ratio of AUC Geometric Coefficient of Variation 33.3	1.115 Ratio of AUC Geometric Coefficient of Variation 32.6	1.136 Ratio of AUC Geometric Coefficient of Variation 39.0	1.221 Ratio of AUC Geometric Coefficient of Variation 26.6

SECONDARY outcome

Timeframe: 0-2 hours post-dose on week 0 and week 80

Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data.

Area under the concentration-time curve, from 0 to 2 hours (AUC0-2h) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. AUC of glucose was measured as 'mmol\*h/L'.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=63 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=64 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=63 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=58 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
AUC0-2h of Glucose at Week 80 Relative to Baseline	1.119 Ratio of AUC Geometric Coefficient of Variation 28.6	1.086 Ratio of AUC Geometric Coefficient of Variation 28.1	1.070 Ratio of AUC Geometric Coefficient of Variation 35.5	1.166 Ratio of AUC Geometric Coefficient of Variation 21.7

SECONDARY outcome

Timeframe: 0-4 hours post-dose on week 0 and week 80

Population: The FAS included all randomised participants. Overall number of participants analysed = participants with available data

Maximum observed concentration (Cmax) of a MMTT stimulated glucose at week 80 is presented as ratio to baseline. Cmax of C-peptide was measured as 'mmol/L'.

Outcome measures

Outcome measures
Measure	NNC0114-0006 + Liraglutide (Experimental) n=63 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=64 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=63 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=58 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Cmax of Glucose at Week 80 Relative to Baseline	1.114 Ratio of Cmax Geometric Coefficient of Variation 25.6	1.074 Ratio of Cmax Geometric Coefficient of Variation 28.7	1.104 Ratio of Cmax Geometric Coefficient of Variation 31.0	1.155 Ratio of Cmax Geometric Coefficient of Variation 21.5

Adverse Events

NNC0114-0006 + Liraglutide

Serious events: 7 serious events

Other events: 57 other events

Deaths: 0 deaths

NNC0114-0006

Serious events: 5 serious events

Other events: 55 other events

Deaths: 0 deaths

Liraglutide

Serious events: 9 serious events

Other events: 62 other events

Deaths: 1 deaths

Placebo

Serious events: 11 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
Publication restrictions are in place

Restriction type: OTHER

Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 0: Activated Memory B-Cells	1.3 Percentage of B cells (%) Standard Deviation 0.9	1.4 Percentage of B cells (%) Standard Deviation 1.0	1.6 Percentage of B cells (%) Standard Deviation 1.1	1.5 Percentage of B cells (%) Standard Deviation 1.0
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 54: Activated Memory B-Cells	1.2 Percentage of B cells (%) Standard Deviation 0.8	1.1 Percentage of B cells (%) Standard Deviation 1.0	1.5 Percentage of B cells (%) Standard Deviation 1.3	1.3 Percentage of B cells (%) Standard Deviation 0.8
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 80: Activated Memory B-Cells	1.2 Percentage of B cells (%) Standard Deviation 0.9	1.1 Percentage of B cells (%) Standard Deviation 0.7	1.5 Percentage of B cells (%) Standard Deviation 1.1	1.5 Percentage of B cells (%) Standard Deviation 1.2
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 0: Mature Naive B-Cells	15.1 Percentage of B cells (%) Standard Deviation 6.7	14.0 Percentage of B cells (%) Standard Deviation 7.1	13.6 Percentage of B cells (%) Standard Deviation 6.9	13.3 Percentage of B cells (%) Standard Deviation 7.4
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 54: Mature Naive B-Cells	14.0 Percentage of B cells (%) Standard Deviation 6.2	14.3 Percentage of B cells (%) Standard Deviation 7.9	13.6 Percentage of B cells (%) Standard Deviation 7.6	13.5 Percentage of B cells (%) Standard Deviation 6.9
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 80: Mature Naive B-Cells	14.3 Percentage of B cells (%) Standard Deviation 7.3	14.2 Percentage of B cells (%) Standard Deviation 8.7	12.0 Percentage of B cells (%) Standard Deviation 5.2	12.8 Percentage of B cells (%) Standard Deviation 7.6
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 0: Antibody-Secreting Cells	0.6 Percentage of B cells (%) Standard Deviation 0.4	0.5 Percentage of B cells (%) Standard Deviation 0.5	0.6 Percentage of B cells (%) Standard Deviation 0.3	0.6 Percentage of B cells (%) Standard Deviation 0.6
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 54: Antibody-Secreting Cells	0.6 Percentage of B cells (%) Standard Deviation 0.5	0.4 Percentage of B cells (%) Standard Deviation 0.4	0.5 Percentage of B cells (%) Standard Deviation 0.3	0.6 Percentage of B cells (%) Standard Deviation 0.7
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 80: Antibody-Secreting Cells	0.5 Percentage of B cells (%) Standard Deviation 0.4	0.4 Percentage of B cells (%) Standard Deviation 0.3	0.4 Percentage of B cells (%) Standard Deviation 0.4	0.6 Percentage of B cells (%) Standard Deviation 0.5
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 0: B-Cells Positive For Both CD19 & CD20	71.9 Percentage of B cells (%) Standard Deviation 9.7	71.1 Percentage of B cells (%) Standard Deviation 11.1	72.1 Percentage of B cells (%) Standard Deviation 8.9	72.2 Percentage of B cells (%) Standard Deviation 8.8
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 54: B-Cells Positive For Both CD19 & CD20	71.1 Percentage of B cells (%) Standard Deviation 12.4	70.8 Percentage of B cells (%) Standard Deviation 12.4	72.1 Percentage of B cells (%) Standard Deviation 8.4	65.9 Percentage of B cells (%) Standard Deviation 13.6
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 80: B-Cells Positive For Both CD19 & CD20	71.0 Percentage of B cells (%) Standard Deviation 10.7	69.8 Percentage of B cells (%) Standard Deviation 11.2	72.8 Percentage of B cells (%) Standard Deviation 10.6	69.6 Percentage of B cells (%) Standard Deviation 13.5
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 0: CD20Neg B-Cell	0.6 Percentage of B cells (%) Standard Deviation 0.5	0.6 Percentage of B cells (%) Standard Deviation 0.7	0.6 Percentage of B cells (%) Standard Deviation 0.7	0.6 Percentage of B cells (%) Standard Deviation 0.5
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 54: CD20Neg B-Cell	0.6 Percentage of B cells (%) Standard Deviation 0.7	0.5 Percentage of B cells (%) Standard Deviation 0.9	0.5 Percentage of B cells (%) Standard Deviation 0.4	0.6 Percentage of B cells (%) Standard Deviation 0.7
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 80: CD20Neg B-Cell	0.5 Percentage of B cells (%) Standard Deviation 0.3	0.5 Percentage of B cells (%) Standard Deviation 0.4	0.6 Percentage of B cells (%) Standard Deviation 1.8	0.7 Percentage of B cells (%) Standard Deviation 1.0
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 0: CD24- B-Cells	29.8 Percentage of B cells (%) Standard Deviation 10.2	31.0 Percentage of B cells (%) Standard Deviation 11.5	31.5 Percentage of B cells (%) Standard Deviation 11.8	32.0 Percentage of B cells (%) Standard Deviation 11.1
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 54: CD24- B-Cells	30.2 Percentage of B cells (%) Standard Deviation 9.4	30.6 Percentage of B cells (%) Standard Deviation 10.8	31.3 Percentage of B cells (%) Standard Deviation 11.9	28.3 Percentage of B cells (%) Standard Deviation 8.9
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 80: CD24- B-Cells	30.0 Percentage of B cells (%) Standard Deviation 8.9	31.6 Percentage of B cells (%) Standard Deviation 10.9	33.4 Percentage of B cells (%) Standard Deviation 12.4	30.7 Percentage of B cells (%) Standard Deviation 11.8
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 0: Class-Switched Memory B Cells	5.0 Percentage of B cells (%) Standard Deviation 3.3	4.6 Percentage of B cells (%) Standard Deviation 2.5	4.8 Percentage of B cells (%) Standard Deviation 3.3	4.9 Percentage of B cells (%) Standard Deviation 3.0
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 54: Class-Switched Memory B Cells	5.0 Percentage of B cells (%) Standard Deviation 3.7	4.2 Percentage of B cells (%) Standard Deviation 2.3	4.6 Percentage of B cells (%) Standard Deviation 2.9	4.8 Percentage of B cells (%) Standard Deviation 2.9
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 80: Class-Switched Memory B Cells	4.6 Percentage of B cells (%) Standard Deviation 3.3	3.6 Percentage of B cells (%) Standard Deviation 2.0	4.6 Percentage of B cells (%) Standard Deviation 3.0	4.5 Percentage of B cells (%) Standard Deviation 2.5
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 0: IgMNeg IgDNeg Switched Memory B-cells	0.1 Percentage of B cells (%) Standard Deviation 0.1	0.1 Percentage of B cells (%) Standard Deviation 0.1	0.1 Percentage of B cells (%) Standard Deviation 0.1	0.1 Percentage of B cells (%) Standard Deviation 0.1
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 54: IgMNeg IgDNeg Switched Memory B-cells	0.1 Percentage of B cells (%) Standard Deviation 0.1	0.1 Percentage of B cells (%) Standard Deviation 0.1	0.1 Percentage of B cells (%) Standard Deviation 0.2	0.1 Percentage of B cells (%) Standard Deviation 0.1
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 80: IgMNeg IgDNeg Switched Memory B-cells	0.1 Percentage of B cells (%) Standard Deviation 0.1	0.2 Percentage of B cells (%) Standard Deviation 0.2	0.1 Percentage of B cells (%) Standard Deviation 0.1	0.1 Percentage of B cells (%) Standard Deviation 0.1
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 0: Non-Class Switched Memory B-Cells	10.2 Percentage of B cells (%) Standard Deviation 6.4	9.6 Percentage of B cells (%) Standard Deviation 5.8	9.6 Percentage of B cells (%) Standard Deviation 5.8	10.1 Percentage of B cells (%) Standard Deviation 6.4
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 54: Non-Class Switched Memory B-Cells	8.5 Percentage of B cells (%) Standard Deviation 4.8	9.0 Percentage of B cells (%) Standard Deviation 5.7	8.7 Percentage of B cells (%) Standard Deviation 5.8	8.9 Percentage of B cells (%) Standard Deviation 5.8
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 80: Non-Class Switched Memory B-Cells	8.2 Percentage of B cells (%) Standard Deviation 4.9	7.2 Percentage of B cells (%) Standard Deviation 4.1	8.0 Percentage of B cells (%) Standard Deviation 5.1	8.9 Percentage of B cells (%) Standard Deviation 6.2
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 0: Total B-Cell Population	72.5 Percentage of B cells (%) Standard Deviation 9.8	71.7 Percentage of B cells (%) Standard Deviation 11.2	72.7 Percentage of B cells (%) Standard Deviation 9.0	72.8 Percentage of B cells (%) Standard Deviation 8.6
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 54: Total B-Cell Population	71.7 Percentage of B cells (%) Standard Deviation 12.1	71.3 Percentage of B cells (%) Standard Deviation 11.9	72.6 Percentage of B cells (%) Standard Deviation 8.4	66.5 Percentage of B cells (%) Standard Deviation 13.3
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 80: Total B-Cell Population	71.4 Percentage of B cells (%) Standard Deviation 10.7	70.3 Percentage of B cells (%) Standard Deviation 11.2	73.5 Percentage of B cells (%) Standard Deviation 9.6	70.4 Percentage of B cells (%) Standard Deviation 13.0
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 0: Transitional B-Cells	11.4 Percentage of B cells (%) Standard Deviation 6.1	9.9 Percentage of B cells (%) Standard Deviation 6.5	9.5 Percentage of B cells (%) Standard Deviation 5.5	9.6 Percentage of B cells (%) Standard Deviation 6.6
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 54: Transitional B-Cells	10.2 Percentage of B cells (%) Standard Deviation 5.6	10.7 Percentage of B cells (%) Standard Deviation 7.7	9.5 Percentage of B cells (%) Standard Deviation 6.3	9.8 Percentage of B cells (%) Standard Deviation 6.4
Change in Biomarker: Immune Phenotyping- B Cell Panel Week 80: Transitional B-Cells	10.8 Percentage of B cells (%) Standard Deviation 6.8	10.5 Percentage of B cells (%) Standard Deviation 8.1	8.1 Percentage of B cells (%) Standard Deviation 4.0	8.9 Percentage of B cells (%) Standard Deviation 6.1

Measure	NNC0114-0006 + Liraglutide (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	NNC0114-0006 (Experimental) n=77 Participants Participants received 12 mg/kg dose of NNC0114-0006 every 6 weeks, intravenously for 54 weeks. Participants took liraglutide placebo once daily, subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Liraglutide (Experimental) n=76 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. Participants took 0.6 mg of liraglutide, once daily, subcutaneously, for first two weeks, 1.2 mg for next 2 weeks and 1.8 mg for rest of the treatment period. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.	Placebo (Placebo) n=77 Participants Participants received NNC0114-0006 placebo (volume equivalent to NNC0114-0006 dose of 12 mg/kg) every 6 weeks, intravenously for 54 weeks. In addition to that, participants took liraglutide placebo once daily subcutaneously, with the volume of placebo equivalent to the volume liraglutide 0.6 mg, 1.2 mg and 1.8 mg. Participants received treatment for 54 weeks followed by an off-treatment observation period of 26 weeks. Participants continued their pre-trial insulin treatment throughout the trial.
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: Total Monocytes in Myeloid Cells	14.2 Percentage of Myeloid cells (%) Standard Deviation 8.9	12.6 Percentage of Myeloid cells (%) Standard Deviation 7.8	14.1 Percentage of Myeloid cells (%) Standard Deviation 9.5	13.4 Percentage of Myeloid cells (%) Standard Deviation 8.7
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: Total Monocytes in Myeloid Cells	13.8 Percentage of Myeloid cells (%) Standard Deviation 9.3	14.9 Percentage of Myeloid cells (%) Standard Deviation 9.8	14.3 Percentage of Myeloid cells (%) Standard Deviation 10.6	12.2 Percentage of Myeloid cells (%) Standard Deviation 8.3
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: Total Monocytes in Myeloid Cells	15.5 Percentage of Myeloid cells (%) Standard Deviation 10.3	13.8 Percentage of Myeloid cells (%) Standard Deviation 9.1	13.6 Percentage of Myeloid cells (%) Standard Deviation 7.6	13.5 Percentage of Myeloid cells (%) Standard Deviation 6.3
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: Total Myeloid DC	3.8 Percentage of Myeloid cells (%) Standard Deviation 2.1	3.6 Percentage of Myeloid cells (%) Standard Deviation 2.3	3.8 Percentage of Myeloid cells (%) Standard Deviation 2.8	3.4 Percentage of Myeloid cells (%) Standard Deviation 2.0
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: Total Myeloid DC	3.7 Percentage of Myeloid cells (%) Standard Deviation 2.3	3.9 Percentage of Myeloid cells (%) Standard Deviation 2.4	3.8 Percentage of Myeloid cells (%) Standard Deviation 2.4	3.2 Percentage of Myeloid cells (%) Standard Deviation 2.1
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: Total Myeloid DC	4.1 Percentage of Myeloid cells (%) Standard Deviation 2.3	4.1 Percentage of Myeloid cells (%) Standard Deviation 2.5	4.1 Percentage of Myeloid cells (%) Standard Deviation 3.0	3.9 Percentage of Myeloid cells (%) Standard Deviation 2.1
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: Total MYDC	30.4 Percentage of Myeloid cells (%) Standard Deviation 9.1	31.4 Percentage of Myeloid cells (%) Standard Deviation 10.2	32.7 Percentage of Myeloid cells (%) Standard Deviation 9.2	31.0 Percentage of Myeloid cells (%) Standard Deviation 9.6
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: Total MYDC	30.4 Percentage of Myeloid cells (%) Standard Deviation 11.3	31.3 Percentage of Myeloid cells (%) Standard Deviation 8.5	31.7 Percentage of Myeloid cells (%) Standard Deviation 11.9	27.2 Percentage of Myeloid cells (%) Standard Deviation 9.2
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: Total MYDC	28.7 Percentage of Myeloid cells (%) Standard Deviation 10.7	30.5 Percentage of Myeloid cells (%) Standard Deviation 7.9	31.6 Percentage of Myeloid cells (%) Standard Deviation 12.0	31.9 Percentage of Myeloid cells (%) Standard Deviation 10.2
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: Total Percent Of Myeloid Cells	94.6 Percentage of Myeloid cells (%) Standard Deviation 3.8	94.7 Percentage of Myeloid cells (%) Standard Deviation 5.4	94.6 Percentage of Myeloid cells (%) Standard Deviation 3.4	94.6 Percentage of Myeloid cells (%) Standard Deviation 4.1
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: Total Percent Of Myeloid Cells	95.1 Percentage of Myeloid cells (%) Standard Deviation 3.6	95.9 Percentage of Myeloid cells (%) Standard Deviation 4.0	95.0 Percentage of Myeloid cells (%) Standard Deviation 3.8	95.6 Percentage of Myeloid cells (%) Standard Deviation 3.7
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: Total Percent Of Myeloid Cells	94.8 Percentage of Myeloid cells (%) Standard Deviation 5.4	95.6 Percentage of Myeloid cells (%) Standard Deviation 4.0	94.6 Percentage of Myeloid cells (%) Standard Deviation 4.4	94.1 Percentage of Myeloid cells (%) Standard Deviation 5.1
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: Total Plasmacytoid Dendritic Cells (PDC)	14.3 Percentage of Myeloid cells (%) Standard Deviation 5.4	12.5 Percentage of Myeloid cells (%) Standard Deviation 6.6	12.0 Percentage of Myeloid cells (%) Standard Deviation 6.3	12.9 Percentage of Myeloid cells (%) Standard Deviation 7.5
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: Total Plasmacytoid Dendritic Cells (PDC)	14.4 Percentage of Myeloid cells (%) Standard Deviation 6.7	13.5 Percentage of Myeloid cells (%) Standard Deviation 5.9	12.0 Percentage of Myeloid cells (%) Standard Deviation 6.1	11.8 Percentage of Myeloid cells (%) Standard Deviation 6.5
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: Total Plasmacytoid Dendritic Cells (PDC)	13.5 Percentage of Myeloid cells (%) Standard Deviation 6.6	12.8 Percentage of Myeloid cells (%) Standard Deviation 6.7	11.6 Percentage of Myeloid cells (%) Standard Deviation 6.3	12.5 Percentage of Myeloid cells (%) Standard Deviation 6.7
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: CD14+ HLA low Myeloid Cells	1.1 Percentage of Myeloid cells (%) Standard Deviation 1.5	1.0 Percentage of Myeloid cells (%) Standard Deviation 1.3	0.9 Percentage of Myeloid cells (%) Standard Deviation 1.2	1.0 Percentage of Myeloid cells (%) Standard Deviation 1.4
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: CD14+ HLA low Myeloid Cells	1.1 Percentage of Myeloid cells (%) Standard Deviation 2.3	0.7 Percentage of Myeloid cells (%) Standard Deviation 0.9	0.7 Percentage of Myeloid cells (%) Standard Deviation 1.1	0.6 Percentage of Myeloid cells (%) Standard Deviation 1.1
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: CD14+ HLA low Myeloid Cells	1.0 Percentage of Myeloid cells (%) Standard Deviation 2.2	0.6 Percentage of Myeloid cells (%) Standard Deviation 0.7	0.9 Percentage of Myeloid cells (%) Standard Deviation 1.2	0.8 Percentage of Myeloid cells (%) Standard Deviation 1.1
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: CD14+ MDSC	68.2 Percentage of Myeloid cells (%) Standard Deviation 20.8	69.1 Percentage of Myeloid cells (%) Standard Deviation 22.3	73.5 Percentage of Myeloid cells (%) Standard Deviation 19.4	70.3 Percentage of Myeloid cells (%) Standard Deviation 18.6
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: CD14+ MDSC	64.0 Percentage of Myeloid cells (%) Standard Deviation 23.4	67.0 Percentage of Myeloid cells (%) Standard Deviation 23.2	69.3 Percentage of Myeloid cells (%) Standard Deviation 21.4	65.9 Percentage of Myeloid cells (%) Standard Deviation 20.2
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: CD14+ MDSC	65.7 Percentage of Myeloid cells (%) Standard Deviation 22.3	62.7 Percentage of Myeloid cells (%) Standard Deviation 20.8	64.1 Percentage of Myeloid cells (%) Standard Deviation 23.3	63.9 Percentage of Myeloid cells (%) Standard Deviation 23.2
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: CD14-HLA II- Myeloid Cells Total Myeloid	80.4 Percentage of Myeloid cells (%) Standard Deviation 11.0	82.2 Percentage of Myeloid cells (%) Standard Deviation 10.4	80.8 Percentage of Myeloid cells (%) Standard Deviation 12.1	81.8 Percentage of Myeloid cells (%) Standard Deviation 11.0
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: CD14-HLA II- Myeloid Cells Total Myeloid	80.9 Percentage of Myeloid cells (%) Standard Deviation 11.7	80.0 Percentage of Myeloid cells (%) Standard Deviation 12.0	80.8 Percentage of Myeloid cells (%) Standard Deviation 12.7	83.5 Percentage of Myeloid cells (%) Standard Deviation 10.5
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: CD14-HLA II- Myeloid Cells Total Myeloid	79.0 Percentage of Myeloid cells (%) Standard Deviation 12.9	81.0 Percentage of Myeloid cells (%) Standard Deviation 10.8	80.9 Percentage of Myeloid cells (%) Standard Deviation 9.7	81.3 Percentage of Myeloid cells (%) Standard Deviation 8.4
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: CD16+ Dendritic Cells	12.5 Percentage of Myeloid cells (%) Standard Deviation 8.4	11.3 Percentage of Myeloid cells (%) Standard Deviation 7.5	12.9 Percentage of Myeloid cells (%) Standard Deviation 10.6	11.5 Percentage of Myeloid cells (%) Standard Deviation 7.5
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: CD16+ Dendritic Cells	10.2 Percentage of Myeloid cells (%) Standard Deviation 8.1	10.3 Percentage of Myeloid cells (%) Standard Deviation 7.5	11.2 Percentage of Myeloid cells (%) Standard Deviation 9.7	12.0 Percentage of Myeloid cells (%) Standard Deviation 9.7
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: CD16+ Dendritic Cells	11.7 Percentage of Myeloid cells (%) Standard Deviation 10.6	9.4 Percentage of Myeloid cells (%) Standard Deviation 6.1	9.2 Percentage of Myeloid cells (%) Standard Deviation 7.1	12.1 Percentage of Myeloid cells (%) Standard Deviation 8.0
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: IMMYE_MDSC	0.3 Percentage of Myeloid cells (%) Standard Deviation 0.2	0.2 Percentage of Myeloid cells (%) Standard Deviation 0.2	0.2 Percentage of Myeloid cells (%) Standard Deviation 0.2	0.2 Percentage of Myeloid cells (%) Standard Deviation 0.4
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: IMMYE_MDSC	0.2 Percentage of Myeloid cells (%) Standard Deviation 0.3	0.2 Percentage of Myeloid cells (%) Standard Deviation 0.3	0.2 Percentage of Myeloid cells (%) Standard Deviation 0.3	0.1 Percentage of Myeloid cells (%) Standard Deviation 0.2
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: IMMYE_MDSC	0.2 Percentage of Myeloid cells (%) Standard Deviation 0.3	0.1 Percentage of Myeloid cells (%) Standard Deviation 0.2	0.2 Percentage of Myeloid cells (%) Standard Deviation 0.2	0.2 Percentage of Myeloid cells (%) Standard Deviation 0.2
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: Intermediate Monocyte Subset	8.6 Percentage of Myeloid cells (%) Standard Deviation 8.4	9.0 Percentage of Myeloid cells (%) Standard Deviation 7.8	8.3 Percentage of Myeloid cells (%) Standard Deviation 8.8	7.7 Percentage of Myeloid cells (%) Standard Deviation 7.3
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: Intermediate Monocyte Subset	6.5 Percentage of Myeloid cells (%) Standard Deviation 4.8	7.3 Percentage of Myeloid cells (%) Standard Deviation 6.7	6.3 Percentage of Myeloid cells (%) Standard Deviation 7.1	5.8 Percentage of Myeloid cells (%) Standard Deviation 5.4
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: Intermediate Monocyte Subset	6.0 Percentage of Myeloid cells (%) Standard Deviation 5.1	6.6 Percentage of Myeloid cells (%) Standard Deviation 6.5	5.7 Percentage of Myeloid cells (%) Standard Deviation 5.4	5.8 Percentage of Myeloid cells (%) Standard Deviation 4.5
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: Non-Classical Monocytes	1.5 Percentage of Myeloid cells (%) Standard Deviation 1.3	1.3 Percentage of Myeloid cells (%) Standard Deviation 0.8	1.2 Percentage of Myeloid cells (%) Standard Deviation 0.8	1.3 Percentage of Myeloid cells (%) Standard Deviation 1.0
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: Non-Classical Monocytes	1.2 Percentage of Myeloid cells (%) Standard Deviation 1.1	1.3 Percentage of Myeloid cells (%) Standard Deviation 0.8	1.1 Percentage of Myeloid cells (%) Standard Deviation 0.8	1.2 Percentage of Myeloid cells (%) Standard Deviation 0.9
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: Non-Classical Monocytes	1.2 Percentage of Myeloid cells (%) Standard Deviation 0.7	1.2 Percentage of Myeloid cells (%) Standard Deviation 0.7	1.0 Percentage of Myeloid cells (%) Standard Deviation 0.6	1.3 Percentage of Myeloid cells (%) Standard Deviation 0.9
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 0: Total Classical Monocytes	87.2 Percentage of Myeloid cells (%) Standard Deviation 9.3	86.7 Percentage of Myeloid cells (%) Standard Deviation 8.1	87.6 Percentage of Myeloid cells (%) Standard Deviation 9.1	88.0 Percentage of Myeloid cells (%) Standard Deviation 8.0
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 54: Total Classical Monocytes	87.8 Percentage of Myeloid cells (%) Standard Deviation 7.9	88.1 Percentage of Myeloid cells (%) Standard Deviation 7.6	88.0 Percentage of Myeloid cells (%) Standard Deviation 8.8	89.3 Percentage of Myeloid cells (%) Standard Deviation 6.8
Change in Biomarker: Immune Phenotyping- Myeloid Cell Panel Week 80: Total Classical Monocytes	89.3 Percentage of Myeloid cells (%) Standard Deviation 6.0	88.5 Percentage of Myeloid cells (%) Standard Deviation 7.1	88.6 Percentage of Myeloid cells (%) Standard Deviation 7.0	89.7 Percentage of Myeloid cells (%) Standard Deviation 5.4