Trial Outcomes & Findings for A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus (NCT NCT02420262)

NCT ID: NCT02420262

Last Updated: 2018-03-29

Results Overview

Change in HbA1c values after 26 weeks of treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

506 participants

Primary outcome timeframe

Week 0, Week 26

Results posted on

2018-03-29

Participant Flow

The trial was conducted at 89 sites in 12 countries: Argentina (3 sites), Czech Republic (5 sites), France (3 sites), Greece (6 sites), Hungary (3 sites), Israel (6 sites), Mexico (3 sites), Russia (7 sites), Slovakia (5 sites), Spain (6 sites), Turkey (5 sites) and United States (37 sites).

Subjects with type 2 diabetes mellitus were on treatment with stable daily dose of insulin glargine (IGlar) between 20 units and 50 units (both inclusive) for at least 56 days prior to screening in combination with a stable daily dose of metformin (≥1500 mg or maximum tolerated dose) for at least 90 days prior to screening.

Participant milestones

Participant milestones
Measure	IDegLira Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.	IGlar + IAsp Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).
Overall Study STARTED	252	254
Overall Study Exposed	252	253
Overall Study COMPLETED	250	249
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	IDegLira Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.	IGlar + IAsp Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	4
Overall Study Unclassified	0	1

Baseline Characteristics

A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IDegLira n=252 Participants Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.	IGlar + IAsp n=254 Participants Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).	Total n=506 Participants Total of all reporting groups
Age, Continuous	58.6 years STANDARD_DEVIATION 9.0 • n=5 Participants	58.0 years STANDARD_DEVIATION 8.6 • n=7 Participants	58.3 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	142 Participants n=5 Participants	137 Participants n=7 Participants	279 Participants n=5 Participants
Sex: Female, Male Male	110 Participants n=5 Participants	117 Participants n=7 Participants	227 Participants n=5 Participants
Glycosylated haemoglobin (HbA1c)	8.21 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.76 • n=5 Participants	8.24 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.81 • n=7 Participants	8.22 percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.78 • n=5 Participants
Body Weight	87.2 kg STANDARD_DEVIATION 16.0 • n=5 Participants	88.2 kg STANDARD_DEVIATION 17.2 • n=7 Participants	87.7 kg STANDARD_DEVIATION 16.6 • n=5 Participants

PRIMARY outcome

Timeframe: Week 0, Week 26

Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". 8 subjects in IDegLira and 9 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.

Change in HbA1c values after 26 weeks of treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=244 Participants Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.	IGlar + IAsp n=245 Participants Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).
Change in HbA1c (Glycosylated Haemoglobin)	-1.48 Percentage of glycosylated haemoglobin Standard Error 0.05	-1.46 Percentage of glycosylated haemoglobin Standard Error 0.05

SECONDARY outcome

Timeframe: Weeks 0-26

Population: The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated". One subject in IGlar + IAsp arm did not contribute to the analysis for this endpoint.

Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia.

Outcome measures

Outcome measures
Measure	IDegLira n=252 Participants Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.	IGlar + IAsp n=253 Participants Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).
Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.	129 Number of episodes	975 Number of episodes

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". 08 subjects in both IDegLira and IGlar + IAsp arm did not contribute to the analysis for this endpoint.

Change in body weight after 26 weeks of treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=244 Participants Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.	IGlar + IAsp n=246 Participants Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).
Change in Body Weight	-0.93 kg Standard Error 0.22	2.64 kg Standard Error 0.22

SECONDARY outcome

Timeframe: After 26 weeks of treatment

Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". 14 subjects in IDegLira and 21 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.

Number of subjects with HbA1c below 7% after 26 weeks of treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=238 Participants Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.	IGlar + IAsp n=233 Participants Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).
Responder for HbA1c Below 7.0% Yes	157 Participants	156 Participants
Responder for HbA1c Below 7.0% No	81 Participants	77 Participants

SECONDARY outcome

Timeframe: After 26 weeks of treatment

Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation "as randomised". 14 subjects in IDegLira and 21 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.

Number of subjects with HbA1c below 6.5% after 26 weeks of treatment.

Outcome measures

Outcome measures
Measure	IDegLira n=238 Participants Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.	IGlar + IAsp n=233 Participants Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).
Responder for HbA1c Below or Equal to 6.5 % Yes	118 Participants	104 Participants
Responder for HbA1c Below or Equal to 6.5 % No	120 Participants	129 Participants

Adverse Events

IDegLira

Serious events: 12 serious events

Other events: 84 other events

Deaths: 0 deaths

IGlar + IAsp

Serious events: 10 serious events

Other events: 79 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	IDegLira n=252 participants at risk Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously once daily (OD) for a duration of 26 weeks. IDegLira was supplied in a 3 mL pre-filled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 units/3.6 mg per mL solution. IDegLira treatment was initiated at 16 dose steps (containing 16 units IDeg /0.6 mg liraglutide) and adjusted twice weekly based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]).The maximum daily dose was 50 dose steps (50U IDeg /1.8 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose), unless there was a safety concern.	IGlar + IAsp n=253 participants at risk Subjects received insulin glargine plus prandial insulin aspart subcutaneously for duration of 26 weeks. A stable pre- trial OD dose of IGlar (20-50 units, in a 3 mL pre-filled Solostar®) was continued with metformin therapy (≥ 1500 mg or the maximum tolerated dose). IAsp was added to the IGlar therapy with a start dose of 4U using a 3 mL pre-filled FlexPen®, as prandial insulin treatment before each main meal. The dose of IGlar was adjusted twice weekly based on the mean of three pre-breakfast SMPG values measured on the days of the titration and the two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72- 90 mg/dL\]). The dose of IAsp was titrated twice weekly based on pre-prandial and bedtime SMPGs, obtained on the three previous days (target SMPG: 4.0 - 6.0 mmol/L).
Eye disorders Diabetic retinopathy	3.6% 9/252 • Number of events 9 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".	5.5% 14/253 • Number of events 15 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".
Gastrointestinal disorders Diarrhoea	6.3% 16/252 • Number of events 24 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".	4.0% 10/253 • Number of events 17 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".
Nervous system disorders Headache	5.6% 14/252 • Number of events 17 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".	7.1% 18/253 • Number of events 23 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".
Infections and infestations Influenza	7.1% 18/252 • Number of events 21 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".	4.7% 12/253 • Number of events 13 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".
Infections and infestations Nasopharyngitis	4.8% 12/252 • Number of events 12 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".	11.9% 30/253 • Number of events 35 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".
Gastrointestinal disorders Nausea	11.1% 28/252 • Number of events 37 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".	1.6% 4/253 • Number of events 4 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".
Infections and infestations Upper respiratory tract infection	6.0% 15/252 • Number of events 15 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".	6.7% 17/253 • Number of events 19 • Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up). The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation "as treated".

Additional Information

Global Clinical Registry (GCR, 1452)

Novo Nordisk A/S

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
Publication restrictions are in place

Restriction type: OTHER