Trial Outcomes & Findings for Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes (NCT NCT00518882)

Results Overview

Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

467 participants

Primary outcome timeframe

week 0, week 26

Results posted on

2017-03-08

Participant Flow

A total of 133 centres in 15 countries: Austria (4), Denmark (6), Finland (5), France (5), Germany (14), Ireland (4), Macedonia (1), Norway (4), Poland (9), Romania (3), Slovenia (3), Spain (4), Sweden (2), Switzerland (4) and United States (65).

Eligible subjects were subjects with type 2 diabetes being treated with oral anti-diabetic (OAD) therapy(ies) for at least 3 months prior to the study. Three subjects were exposed to study drug prior to randomisation, and thus only included in safety analysis set.

Participant milestones

Participant milestones
Measure	Liraglutide -> Liraglutide -> Liraglutide Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Double-Blind, Week 0-26 STARTED	235	232
Double-Blind, Week 0-26 Randomised	233	231
Double-Blind, Week 0-26 COMPLETED	202	187
Double-Blind, Week 0-26 NOT COMPLETED	33	45
Open-Label Extension, Week 26-78 STARTED	202	187
Open-Label Extension, Week 26-78 COMPLETED	161	138
Open-Label Extension, Week 26-78 NOT COMPLETED	41	49

Reasons for withdrawal

Reasons for withdrawal
Measure	Liraglutide -> Liraglutide -> Liraglutide Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Double-Blind, Week 0-26 Adverse Event	23	31
Double-Blind, Week 0-26 Lack of Efficacy	1	0
Double-Blind, Week 0-26 Protocol Violation	4	3
Double-Blind, Week 0-26 Withdrawal criteria	1	1
Double-Blind, Week 0-26 Lost to follow up	2	1
Double-Blind, Week 0-26 Subject decision	1	1
Double-Blind, Week 0-26 Withdrawal of consent	1	3
Double-Blind, Week 0-26 Loss of trust	0	1
Double-Blind, Week 0-26 Fear of hypoglycaemia	0	1
Double-Blind, Week 0-26 Hypoglycaemia	0	2
Double-Blind, Week 0-26 Mutual consent	0	1
Open-Label Extension, Week 26-78 Adverse Event	3	9
Open-Label Extension, Week 26-78 Lack of Efficacy	6	5
Open-Label Extension, Week 26-78 Protocol Violation	3	4
Open-Label Extension, Week 26-78 Withdrawel criteria	1	2
Open-Label Extension, Week 26-78 Hypoglycaemia	0	1
Open-Label Extension, Week 26-78 Lost to follow up	1	1
Open-Label Extension, Week 26-78 Consent withdrawn	2	1
Open-Label Extension, Week 26-78 Change in treatment	1	1
Open-Label Extension, Week 26-78 Creatine increased	1	0
Open-Label Extension, Week 26-78 Decreased kidney function	1	0
Open-Label Extension, Week 26-78 Exclusion criteria	2	0
Open-Label Extension, Week 26-78 Subject decision	2	0
Open-Label Extension, Week 26-78 Completed extension 1 (weeks 26-40)	18	25

Baseline Characteristics

Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liraglutide -> Liraglutide -> Liraglutide n=233 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=231 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Total n=464 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 9.8 • n=5 Participants	57.1 years STANDARD_DEVIATION 10.8 • n=7 Participants	56.7 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	104 Participants n=7 Participants	223 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	127 Participants n=7 Participants	241 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants	25 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	201 Participants n=5 Participants	206 Participants n=7 Participants	407 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	216 Participants n=5 Participants	210 Participants n=7 Participants	426 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Previous OAD treatment Metformin/Sulphonylurea Combination	145 participants n=5 Participants	147 participants n=7 Participants	292 participants n=5 Participants
Previous OAD treatment Sulphonylurea	24 participants n=5 Participants	21 participants n=7 Participants	45 participants n=5 Participants
Previous OAD treatment Metformin	64 participants n=5 Participants	63 participants n=7 Participants	127 participants n=5 Participants
BMI	32.9 kg/m2 STANDARD_DEVIATION 5.5 • n=5 Participants	32.9 kg/m2 STANDARD_DEVIATION 5.7 • n=7 Participants	32.9 kg/m2 STANDARD_DEVIATION 5.6 • n=5 Participants
Duration of diabetes	8.5 years STANDARD_DEVIATION 6.2 • n=5 Participants	7.9 years STANDARD_DEVIATION 5.9 • n=7 Participants	8.2 years STANDARD_DEVIATION 6.0 • n=5 Participants
HbA1c	8.4 percentage of total haemoglobin STANDARD_DEVIATION 1.0 • n=5 Participants	8.2 percentage of total haemoglobin STANDARD_DEVIATION 1.0 • n=7 Participants	8.3 percentage of total haemoglobin STANDARD_DEVIATION 1.0 • n=5 Participants
Height	1.68 m STANDARD_DEVIATION 0.10 • n=5 Participants	1.68 m STANDARD_DEVIATION 0.10 • n=7 Participants	1.68 m STANDARD_DEVIATION 0.10 • n=5 Participants
Weight	93.1 kg STANDARD_DEVIATION 20.1 • n=5 Participants	93.0 kg STANDARD_DEVIATION 19.5 • n=7 Participants	93.1 kg STANDARD_DEVIATION 19.8 • n=5 Participants

PRIMARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=227 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=226 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Glycosylated A1c (HbA1c) at Week 26	-1.12 percentage point of total HbA1c Standard Error 0.08	-0.79 percentage point of total HbA1c Standard Error 0.08

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Percentage point change in glycosylated A1c (HbA1c) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=198 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=183 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Glycosylated A1c (HbA1c), Weeks 26-78	0.25 percentage point of total HbA1c Standard Deviation 0.803	-0.00 percentage point of total HbA1c Standard Deviation 0.924

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Percentage point change in glycosylated A1c (HbA1c) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=198 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=183 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Glycosylated A1c (HbA1c) at Week 78	-0.98 percentage point of total HbA1c Standard Deviation 1.119	-0.85 percentage point of total HbA1c Standard Deviation 1.105

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 26 (end of randomisation)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=233 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=231 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26 Treatment target HbA1c < 7%	53 percentage (%) of subjects	42 percentage (%) of subjects
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26 Treatment target HbA1c =< 6.5%	34 percentage (%) of subjects	20 percentage (%) of subjects

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Percentage of subjects achieving treatment target of HbA1c less than 7.0% or less than or equal to 6.5% at Week 78 (end of treatment)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=200 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=186 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78 Treatment target HbA1c < 7%	47 percentage (%) of subjects	48 percentage (%) of subjects
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78 Treatment target HbA1c =< 6.5%	31 percentage (%) of subjects	35 percentage (%) of subjects

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=231 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=229 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Body Weight at Week 26	-3.24 kg Standard Error 0.33	-2.87 kg Standard Error 0.33

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in body weight from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=199 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=184 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Body Weight, Weeks 26-78	-0.4 kg Standard Deviation 3.24	-0.7 kg Standard Deviation 3.67

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in body weight from baseline (Week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=199 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=184 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Body Weight at Week 78	-3.3 kg Standard Deviation 4.63	-3.2 kg Standard Deviation 4.44

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=225 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=219 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Fasting Plasma Glucose at Week 26	-1.61 mmol/L Standard Error 0.20	-0.60 mmol/L Standard Error 0.20

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in fasting plasma glucose from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=197 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=182 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Fasting Plasma Glucose, Weeks 26-78	0.7 mmol/L Standard Deviation 1.84	-0.1 mmol/L Standard Deviation 2.42

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in fasting plasma glucose from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=197 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=182 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Fasting Plasma Glucose at Week 78	-1.3 mmol/L Standard Deviation 2.50	-0.8 mmol/L Standard Deviation 2.76

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after breakfast.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=207 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=196 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 26	-0.83 mmol/L Standard Error 0.28	-2.16 mmol/L Standard Error 0.28

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=207 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=196 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 26	0.06 mmol/L Standard Error 0.28	0.06 mmol/L Standard Error 0.28

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=204 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=196 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 26	-1.10 mmol/L Standard Error 0.31	-2.11 mmol/L Standard Error 0.31

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in mean prandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=191 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=173 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Prandial Increment of Plasma Glucose After Breakfast, Weeks 26-78	-0.22 mmol/L Standard Deviation 2.866	1.15 mmol/L Standard Deviation 3.253

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in mean prandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after a lunch.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=191 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=173 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Prandial Increment of Plasma Glucose After Lunch, Weeks 26-78	0.05 mmol/L Standard Deviation 3.307	-0.09 mmol/L Standard Deviation 3.419

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in mean prandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=190 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=172 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Prandial Increment of Plasma Glucose After Dinner, Weeks 26-78	0.22 mmol/L Standard Deviation 3.053	1.07 mmol/L Standard Deviation 3.775

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in mean prandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=192 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=167 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Prandial Increment of Plasma Glucose After Breakfast at Week 78	-1.08 mmol/L Standard Deviation 3.662	-0.99 mmol/L Standard Deviation 3.467

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in mean prandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=192 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=168 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Prandial Increment of Plasma Glucose After Lunch at Week 78	0.26 mmol/L Standard Deviation 4.158	-0.37 mmol/L Standard Deviation 3.838

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in mean prandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=190 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=166 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Prandial Increment of Plasma Glucose After Dinner at Week 78	-0.35 mmol/L Standard Deviation 3.975	-0.95 mmol/L Standard Deviation 3.230

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=207 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=197 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 26	-3.20 mmol/L Standard Error 0.31	-3.93 mmol/L Standard Error 0.30

SECONDARY outcome

Timeframe: week 0. week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=208 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=196 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 26	-2.74 mmol/L Standard Error 0.28	-2.35 mmol/L Standard Error 0.28

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 26 weeks (end of randomisation). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=206 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=197 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 26	-3.05 mmol/L Standard Error 0.28	-3.59 mmol/L Standard Error 0.27

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in mean postprandial increment of plasma glucose after breakfast from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=191 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=173 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast, Weeks 26-78	0.06 mmol/L Standard Deviation 2.827	0.72 mmol/L Standard Deviation 3.270

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in mean postprandial increment of plasma glucose after lunch from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=191 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=173 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Postprandial Increment of Plasma Glucose After Lunch, Weeks 26-78	0.67 mmol/L Standard Deviation 3.041	-0.09 mmol/L Standard Deviation 2.989

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in mean postprandial increment of plasma glucose after dinner from Week 26 (end of randomisation) to Week 78 (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=191 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=172 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Postprandial Increment of Plasma Glucose After Dinner, Weeks 26-78	0.32 mmol/L Standard Deviation 2.705	0.58 mmol/L Standard Deviation 3.114

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in mean postprandial increment of plasma glucose after breakfast from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after breakfast.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=192 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=168 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Postprandial Increment of Plasma Glucose After Breakfast at Week 78	-3.31 mmol/L Standard Deviation 3.857	-3.13 mmol/L Standard Deviation 3.560

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in mean postprandial increment of plasma glucose after lunch from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after lunch.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=192 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=168 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Postprandial Increment of Plasma Glucose After Lunch at Week 78	-1.93 mmol/L Standard Deviation 3.703	-2.17 mmol/L Standard Deviation 3.654

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in mean postprandial increment of plasma glucose after dinner from baseline (week 0) to 78 weeks (end of treatment). Prandial increments of plasma glucose were calculated as the difference between plasma glucose values measured before and after dinner.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=191 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=167 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Mean Postprandial Increment of Plasma Glucose After Dinner at Week 78	-2.21 mmol/L Standard Deviation 3.752	-2.55 mmol/L Standard Deviation 3.625

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in Beta-cell function from baseline (week 0) to 26 weeks (end of randomisation). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=214 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=214 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Beta-cell Function at Week 26	32.12 percentage point (%point) Standard Error 6.75	2.74 percentage point (%point) Standard Error 6.75

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in Beta-cell function from Week 26 (end of randomisation) to Week 78 (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=198 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=179 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Beta-cell Function, Weeks 26-78	-18.18 percentage point (%point) Standard Deviation 62.811	2.29 percentage point (%point) Standard Deviation 52.997

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study drugs.

Change in Beta-cell function from baseline (week 0) to 78 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=189 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=176 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Beta-cell Function at Week 78	24.86 percentage point (%point) Standard Deviation 59.326	11.13 percentage point (%point) Standard Deviation 87.145

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in total cholesterol (TC) from baseline (week 0) to 26 weeks (end of randomisation)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=226 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=220 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Total Cholesterol at Week 26	-0.20 mmol/L Standard Error 0.07	-0.09 mmol/L Standard Error 0.07

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the trial products.

Change in total cholesterol (TC) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=199 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=184 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Total Cholesterol, Weeks 26-78	0.11 mmol/L Standard Deviation 0.774	0.12 mmol/L Standard Deviation 0.804

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in total cholesterol (TC) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=198 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=183 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Total Cholesterol at Week 78	-0.07 mmol/L Standard Deviation 0.859	0.09 mmol/L Standard Deviation 0.890

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 26 weeks (end of randomisation)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=219 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=215 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Low-density Lipoprotein-cholesterol at Week 26	-0.44 mmol/L Standard Error 0.06	-0.40 mmol/L Standard Error 0.06

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in low-density lipoprotein-cholesterol (LDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=199 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=180 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Low-density Lipoprotein-cholesterol, Weeks 26-78	0.03 mmol/L Standard Deviation 0.606	0.08 mmol/L Standard Deviation 0.720

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in Low-density Lipoprotein-cholesterol (LDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=183 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=176 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Low-density Lipoprotein-cholesterol at Week 78	-0.30 mmol/L Standard Deviation 0.604	-0.21 mmol/L Standard Deviation 0.647

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in very low-density lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 26 weeks (end of randomisation)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=216 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=212 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Very Low-density Lipoprotein-cholesterol at Week 26	0.20 mmol/L Standard Error 0.04	0.27 mmol/L Standard Error 0.04

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=199 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=180 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Very Low-density Lipoprotein-cholesterol, Weeks 26-78	0.06 mmol/L Standard Deviation 0.290	0.03 mmol/L Standard Deviation 0.307

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=173 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=168 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Very Low-density Lipoprotein-cholesterol at Week 78	0.27 mmol/L Standard Deviation 0.306	0.31 mmol/L Standard Deviation 0.346

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 26 weeks (end of randomisation)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=226 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=220 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in High-density Lipoprotein-cholesterol at Week 26	-0.04 mmol/L Standard Error 0.02	-0.05 mmol/L Standard Error 0.02

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in High-density Lipoprotein-cholesterol (HDL-C) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=119 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=180 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in High-density Lipoprotein-cholesterol, Weeks 26-78	-0.01 mmol/L Standard Deviation 0.150	0.00 mmol/L Standard Deviation 0.141

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in High-density Lipoprotein-cholesterol (HDL-C) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=183 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=176 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in High-density Lipoprotein-cholesterol at Week 78	-0.03 mmol/L Standard Deviation 0.159	-0.02 mmol/L Standard Deviation 0.165

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in triglyceride (TG) from from baseline (week 0) to 26 weeks (end of randomisation)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=225 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=220 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Triglyceride at Week 26	-0.41 mmol/L Standard Error 0.10	-0.23 mmol/L Standard Error 0.10

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in Triglyceride (TG) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=198 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=184 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Triglyceride, Weeks 26-78	0.1 mmol/L Standard Deviation 0.82	-0.0 mmol/L Standard Deviation 0.96

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in triglyceride (TG) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=198 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=183 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Triglyceride at Week 78	-0.3 mmol/L Standard Deviation 1.07	-0.1 mmol/L Standard Deviation 1.47

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in Free Fatty Acid (FFA) from baseline (week 0) to 26 weeks (end of randomisation)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=220 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=222 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Free Fatty Acid at Week 26	-0.17 mmol/L Standard Error 0.02	-0.10 mmol/L Standard Error 0.02

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in Free Fatty Acid (FFA) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=199 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=182 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Free Fatty Acid, Weeks 26-78	0.06 mmol/L Standard Deviation 0.269	0.01 mmol/L Standard Deviation 0.272

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in Free Fatty Acid (FFA) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=195 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=182 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Free Fatty Acid at Week 78	-0.10 mmol/L Standard Deviation 0.273	-0.07 mmol/L Standard Deviation 0.302

SECONDARY outcome

Timeframe: week 0, week 26

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to study drug.

Change in apolipoprotein B (ApoB) from baseline (week 0) to 26 weeks (end of randomisation)

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=226 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=222 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Apolipoprotein B at Week 26	-0.06 g/L Standard Error 0.02	-0.03 g/L Standard Error 0.02

SECONDARY outcome

Timeframe: week 26, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in apolipoprotein B (ApoB) from Week 26 (end of randomisation) to Week 78 (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=199 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=184 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Apolipoprotein B, Weeks 26-78	-0.02 g/L Standard Deviation 0.168	-0.03 g/L Standard Deviation 0.189

SECONDARY outcome

Timeframe: week 0, week 78

Population: Intention to Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who entered the extension period and who had been exposed to at least one dose of the study products.

Change in apolipoprotein B (ApoB) from baseline (week 0) to 78 weeks (end of treatment) within each treatment group (the liraglutide -\> liraglutide group and the exenatide -\> liraglutide group).

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=198 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=184 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Change in Apolipoprotein B at Week 78	-0.08 g/L Standard Deviation 0.176	-0.07 g/L Standard Deviation 0.192

SECONDARY outcome

Timeframe: weeks 0-26

Population: The safety analysis set is all subjects who had been exposed to at least one dose of the study products.

Total number of hypoglycaemic episodes occurring after baseline (week 0) and until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=235 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=232 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Hypoglycaemic Episodes at Week 26 Major	0 episodes	2 episodes
Hypoglycaemic Episodes at Week 26 Minor	208 episodes	264 episodes
Hypoglycaemic Episodes at Week 26 Symptoms only	79 episodes	93 episodes

SECONDARY outcome

Timeframe: weeks 26-78

Population: The safety analysis set is all subjects who had been exposed to at least one dose of the study products.

Total number of hypoglycaemic episodes occurring after end of randomisation (week 26) and until week 78 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Outcome measures

Outcome measures
Measure	Liraglutide -> Liraglutide -> Liraglutide n=202 Participants Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=187 Participants Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Hypoglyceamic Episodes, Weeks 26-78 Minor	140 episodes	172 episodes
Hypoglyceamic Episodes, Weeks 26-78 Major	1 episodes	0 episodes
Hypoglyceamic Episodes, Weeks 26-78 Symptoms only	37 episodes	32 episodes

Adverse Events

Liraglutide -> Liraglutide -> Liraglutide

Serious events: 23 serious events

Other events: 162 other events

Deaths: 0 deaths

Exenatide -> Liraglutide -> Liraglutide

Serious events: 23 serious events

Other events: 167 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Public Access to Clinical Trials

Novo Nordisk A/S

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of any investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Liraglutide -> Liraglutide -> Liraglutide n=235 participants at risk Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)	Exenatide -> Liraglutide -> Liraglutide n=232 participants at risk Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
Metabolism and nutrition disorders Anorexia	4.3% 10/235 • Number of events 10 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	5.2% 12/232 • Number of events 12 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Musculoskeletal and connective tissue disorders Back pain	9.4% 22/235 • Number of events 30 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	5.2% 12/232 • Number of events 13 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Infections and infestations Bronchitis	6.4% 15/235 • Number of events 18 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	8.6% 20/232 • Number of events 22 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Gastrointestinal disorders Constipation	7.7% 18/235 • Number of events 18 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	4.3% 10/232 • Number of events 13 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Gastrointestinal disorders Diarrhoea	14.9% 35/235 • Number of events 47 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	15.9% 37/232 • Number of events 50 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Nervous system disorders Dizziness	6.0% 14/235 • Number of events 16 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	3.9% 9/232 • Number of events 9 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Gastrointestinal disorders Dyspepsia	10.6% 25/235 • Number of events 35 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	6.0% 14/232 • Number of events 17 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Nervous system disorders Headache	12.3% 29/235 • Number of events 38 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	12.1% 28/232 • Number of events 40 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Vascular disorders Hypertension	4.3% 10/235 • Number of events 10 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	5.2% 12/232 • Number of events 12 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Infections and infestations Influenza	5.5% 13/235 • Number of events 14 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	4.7% 11/232 • Number of events 11 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Infections and infestations Nasopharyngitis	18.3% 43/235 • Number of events 59 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	18.1% 42/232 • Number of events 71 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Gastrointestinal disorders Nausea	27.2% 64/235 • Number of events 87 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	29.3% 68/232 • Number of events 92 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Infections and infestations Sinusitis	5.1% 12/235 • Number of events 14 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	3.9% 9/232 • Number of events 13 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Infections and infestations Upper respiratory tract infection	11.1% 26/235 • Number of events 33 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	12.1% 28/232 • Number of events 30 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.
Gastrointestinal disorders Vomiting	8.1% 19/235 • Number of events 20 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.	11.2% 26/232 • Number of events 31 • The adverse events were collected in a time span of 78 weeks. The safety analysis set included all subjects who had been exposed to at least one dose of the study products.