Trial Outcomes & Findings for Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes (NCT NCT00614120)

NCT ID: NCT00614120

Last Updated: 2017-03-08

Results Overview

Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

929 participants

Primary outcome timeframe

week 0, week 16

Results posted on

2017-03-08

Participant Flow

A total of 51 centres in three countries: China (17), India (24) and South Korea (10)

A metformin run-in period of 3 weeks followed by a metformin maintenance period of 3 weeks before randomisation with dose levels increased to 2000 mg/day. Subjects already on metformin therapy at enrolment could go through a modified titration period or advance directly to the metformin maintenance period at the discretion of the investigator.

Participant milestones

Participant milestones
Measure	Lira 0.6 + Met Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
Overall Study STARTED	231	233	234	231
Overall Study Exposed to Study Drug	231	233	233	231
Overall Study COMPLETED	202	187	175	215
Overall Study NOT COMPLETED	29	46	59	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Lira 0.6 + Met Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
Overall Study Adverse Event	9	22	30	3
Overall Study Lack of Efficacy	3	3	2	2
Overall Study Protocol Violation	2	5	3	1
Overall Study Withdrawal criteria	1	0	0	0
Overall Study Withdrawal by Subject	9	10	16	3
Overall Study Did not meet trial criteria	0	1	1	1
Overall Study hCG positive (not pregnant)	0	0	1	0
Overall Study Hypoglycaemia	0	0	0	1
Overall Study Lack of trial product	3	3	2	0
Overall Study Late syphilis, latent	1	0	0	0
Overall Study Taken inhibition medication eg Prandin	0	0	1	1
Overall Study Lost to Follow-up	1	2	3	4

Baseline Characteristics

Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lira 0.6 + Met n=231 Participants Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met n=233 Participants Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met n=234 Participants Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met n=231 Participants Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo	Total n=929 Participants Total of all reporting groups
Age, Continuous	53.5 years STANDARD_DEVIATION 9.5 • n=99 Participants	53.5 years STANDARD_DEVIATION 9.6 • n=107 Participants	52.7 years STANDARD_DEVIATION 9.1 • n=206 Participants	53.6 years STANDARD_DEVIATION 9.7 • n=7 Participants	53.3 years STANDARD_DEVIATION 9.5 • n=31 Participants
Sex: Female, Male Female	106 Participants n=99 Participants	105 Participants n=107 Participants	108 Participants n=206 Participants	96 Participants n=7 Participants	415 Participants n=31 Participants
Sex: Female, Male Male	125 Participants n=99 Participants	128 Participants n=107 Participants	126 Participants n=206 Participants	135 Participants n=7 Participants	514 Participants n=31 Participants
Previous OAD treatment Mono-therapy	72 participants n=99 Participants	74 participants n=107 Participants	75 participants n=206 Participants	68 participants n=7 Participants	289 participants n=31 Participants
Previous OAD treatment Combination therapy	159 participants n=99 Participants	159 participants n=107 Participants	159 participants n=206 Participants	163 participants n=7 Participants	640 participants n=31 Participants
BMI	25.9 kg/m2 STANDARD_DEVIATION 4.2 • n=99 Participants	25.4 kg/m2 STANDARD_DEVIATION 3.7 • n=107 Participants	25.8 kg/m2 STANDARD_DEVIATION 3.8 • n=206 Participants	25.3 kg/m2 STANDARD_DEVIATION 3.7 • n=7 Participants	25.6 kg/m2 STANDARD_DEVIATION 3.8 • n=31 Participants
Duration of diabetes	7.4 years STANDARD_DEVIATION 5.4 • n=99 Participants	7.5 years STANDARD_DEVIATION 5.3 • n=107 Participants	7.2 years STANDARD_DEVIATION 5.2 • n=206 Participants	7.8 years STANDARD_DEVIATION 6.1 • n=7 Participants	7.5 years STANDARD_DEVIATION 5.5 • n=31 Participants
Height	1.63 m STANDARD_DEVIATION 0.09 • n=99 Participants	1.63 m STANDARD_DEVIATION 0.09 • n=107 Participants	1.62 m STANDARD_DEVIATION 0.08 • n=206 Participants	1.64 m STANDARD_DEVIATION 0.09 • n=7 Participants	1.63 m STANDARD_DEVIATION 0.09 • n=31 Participants
Weight	68.6 kg STANDARD_DEVIATION 11.6 • n=99 Participants	67.4 kg STANDARD_DEVIATION 11.3 • n=107 Participants	68.2 kg STANDARD_DEVIATION 11.9 • n=206 Participants	68.2 kg STANDARD_DEVIATION 11.9 • n=7 Participants	68.1 kg STANDARD_DEVIATION 11.7 • n=31 Participants

PRIMARY outcome

Timeframe: week 0, week 16

Population: The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).

Outcome measures

Outcome measures
Measure	Lira 0.6 + Met n=226 Participants Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met n=222 Participants Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met n=221 Participants Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met n=230 Participants Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
Change in Glycosylated Haemoglobin A1c (HbA1c)	-1.0 percentage point of total HbA1c Standard Deviation 1.04	-1.3 percentage point of total HbA1c Standard Deviation 1.09	-1.4 percentage point of total HbA1c Standard Deviation 1.23	-1.3 percentage point of total HbA1c Standard Deviation 0.98

SECONDARY outcome

Timeframe: week 0, week 16

Population: The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Change in body weight from baseline (week 0) to 16 weeks (end of treatment)

Outcome measures

Outcome measures
Measure	Lira 0.6 + Met n=227 Participants Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met n=225 Participants Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met n=224 Participants Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met n=231 Participants Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
Change in Body Weight	-1.8 kg Standard Deviation 2.2	-2.3 kg Standard Deviation 2.4	-2.4 kg Standard Deviation 2.6	0.1 kg Standard Deviation 2.2

SECONDARY outcome

Timeframe: week 0, week 16

Population: The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.

Outcome measures

Outcome measures
Measure	Lira 0.6 + Met n=224 Participants Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met n=226 Participants Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met n=222 Participants Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met n=229 Participants Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
Change in Self-measured Fasting Plasma Glucose	-1.83 mg/dL Standard Deviation 2.66	-1.96 mg/dL Standard Deviation 2.35	-2.28 mg/dL Standard Deviation 2.94	-2.13 mg/dL Standard Deviation 2.25

SECONDARY outcome

Timeframe: week 0, 8, 12 and 16

Population: The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).

Outcome measures

Outcome measures
Measure	Lira 0.6 + Met n=231 Participants Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met n=233 Participants Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met n=233 Participants Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met n=231 Participants Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
7-point Self-measured Plasma Glucose Profiles Week 0 - Before breakfast	168.2 mg/dl Standard Deviation 43.5	167.5 mg/dl Standard Deviation 42.5	168.8 mg/dl Standard Deviation 40.4	163.8 mg/dl Standard Deviation 41.2
7-point Self-measured Plasma Glucose Profiles Week 0 - 90 minutes after breakfast	245.9 mg/dl Standard Deviation 71.6	248.0 mg/dl Standard Deviation 70.0	245.4 mg/dl Standard Deviation 63.8	238.5 mg/dl Standard Deviation 62.4
7-point Self-measured Plasma Glucose Profiles Week 0 - Before lunch	178.5 mg/dl Standard Deviation 62.7	180.5 mg/dl Standard Deviation 63.5	176.9 mg/dl Standard Deviation 56.8	175.8 mg/dl Standard Deviation 61.0
7-point Self-measured Plasma Glucose Profiles Week 0 - 90 minutes after lunch	234.2 mg/dl Standard Deviation 68.7	232.3 mg/dl Standard Deviation 67.0	234.4 mg/dl Standard Deviation 64.2	227.6 mg/dl Standard Deviation 67.0
7-point Self-measured Plasma Glucose Profiles Week 0 - Before dinner	194.8 mg/dl Standard Deviation 63.0	184.8 mg/dl Standard Deviation 65.0	190.9 mg/dl Standard Deviation 61.7	180.2 mg/dl Standard Deviation 59.2
7-point Self-measured Plasma Glucose Profiles Week 0 - 90 minutes after dinner	239.6 mg/dl Standard Deviation 65.3	239.6 mg/dl Standard Deviation 71.3	244.0 mg/dl Standard Deviation 69.8	231.6 mg/dl Standard Deviation 60.3
7-point Self-measured Plasma Glucose Profiles Week 0 - Bedtime	205.7 mg/dl Standard Deviation 69.6	208.1 mg/dl Standard Deviation 67.5	219.3 mg/dl Standard Deviation 71.7	202.7 mg/dl Standard Deviation 66.4
7-point Self-measured Plasma Glucose Profiles Week 8 - Before breakfast	137.0 mg/dl Standard Deviation 31.2	130.4 mg/dl Standard Deviation 28.0	133.7 mg/dl Standard Deviation 28.4	130.1 mg/dl Standard Deviation 31.8
7-point Self-measured Plasma Glucose Profiles Week 8 - 90 minutes after breakfast	198.5 mg/dl Standard Deviation 55.8	190.1 mg/dl Standard Deviation 50.8	178.5 mg/dl Standard Deviation 48.2	201.2 mg/dl Standard Deviation 54.4
7-point Self-measured Plasma Glucose Profiles Week 8 - Before lunch	144.8 mg/dl Standard Deviation 45.2	136.5 mg/dl Standard Deviation 41.8	138.0 mg/dl Standard Deviation 37.8	132.6 mg/dl Standard Deviation 46.1
7-point Self-measured Plasma Glucose Profiles Week 8 - 90 minutes after lunch	187.2 mg/dl Standard Deviation 48.7	176.9 mg/dl Standard Deviation 49.5	177.9 mg/dl Standard Deviation 48.4	184.3 mg/dl Standard Deviation 54.2
7-point Self-measured Plasma Glucose Profiles Week 8 - Before dinner	159.1 mg/dl Standard Deviation 47.5	147.8 mg/dl Standard Deviation 40.1	144.2 mg/dl Standard Deviation 40.6	143.3 mg/dl Standard Deviation 47.8
7-point Self-measured Plasma Glucose Profiles Week 8 - 90 minutes after dinner	193.7 mg/dl Standard Deviation 53.2	187.1 mg/dl Standard Deviation 49.3	183.3 mg/dl Standard Deviation 53.9	190.2 mg/dl Standard Deviation 51.7
7-point Self-measured Plasma Glucose Profiles Week 8 - Bedtime	169.1 mg/dl Standard Deviation 51.5	161.6 mg/dl Standard Deviation 47.1	155.8 mg/dl Standard Deviation 45.6	163.6 mg/dl Standard Deviation 50.5
7-point Self-measured Plasma Glucose Profiles Week 12 - Before breakfast	137.8 mg/dl Standard Deviation 33.6	130.2 mg/dl Standard Deviation 25.0	130.2 mg/dl Standard Deviation 26.8	128.5 mg/dl Standard Deviation 29.7
7-point Self-measured Plasma Glucose Profiles Week 12 - 90 minutes after breakfast	197.5 mg/dl Standard Deviation 54.2	185.7 mg/dl Standard Deviation 49.4	178.6 mg/dl Standard Deviation 51.6	200.8 mg/dl Standard Deviation 57.9
7-point Self-measured Plasma Glucose Profiles Week 12 - Before lunch	141.8 mg/dl Standard Deviation 48.3	135.6 mg/dl Standard Deviation 40.3	134.1 mg/dl Standard Deviation 40.3	129.3 mg/dl Standard Deviation 47.7
7-point Self-measured Plasma Glucose Profiles Week 12 - 90 minutes after lunch	183.7 mg/dl Standard Deviation 50.0	174.7 mg/dl Standard Deviation 46.2	173.7 mg/dl Standard Deviation 53.1	185.3 mg/dl Standard Deviation 52.0
7-point Self-measured Plasma Glucose Profiles Week 12 - Before dinner	156.4 mg/dl Standard Deviation 44.8	143.4 mg/dl Standard Deviation 36.1	144.5 mg/dl Standard Deviation 43.0	144.2 mg/dl Standard Deviation 49.2
7-point Self-measured Plasma Glucose Profiles Week 12 - 90 minutes after dinner	197.2 mg/dl Standard Deviation 51.8	185.7 mg/dl Standard Deviation 47.1	183.5 mg/dl Standard Deviation 51.7	188.5 mg/dl Standard Deviation 50.1
7-point Self-measured Plasma Glucose Profiles Week 12 - Bedtime	168.2 mg/dl Standard Deviation 52.1	158.9 mg/dl Standard Deviation 45.3	158.9 mg/dl Standard Deviation 47.0	159.9 mg/dl Standard Deviation 47.6
7-point Self-measured Plasma Glucose Profiles Week 16 - Before breakfast	137.3 mg/dl Standard Deviation 31.2	132.9 mg/dl Standard Deviation 26.4	128.6 mg/dl Standard Deviation 26.1	131.0 mg/dl Standard Deviation 35.3
7-point Self-measured Plasma Glucose Profiles Week 16 - 90 minutes after breakfast	195.6 mg/dl Standard Deviation 57.1	188.7 mg/dl Standard Deviation 51.6	177.6 mg/dl Standard Deviation 51.6	195.1 mg/dl Standard Deviation 57.4
7-point Self-measured Plasma Glucose Profiles Week 16 - Before lunch	140.5 mg/dl Standard Deviation 41.3	137.0 mg/dl Standard Deviation 40.3	137.8 mg/dl Standard Deviation 40.8	128.8 mg/dl Standard Deviation 45.4
7-point Self-measured Plasma Glucose Profiles Week 16 - 90 minutes after lunch	185.8 mg/dl Standard Deviation 44.4	181.4 mg/dl Standard Deviation 46.7	173.2 mg/dl Standard Deviation 50.7	182.2 mg/dl Standard Deviation 51.8
7-point Self-measured Plasma Glucose Profiles Week 16 - Before dinner	151.5 mg/dl Standard Deviation 38.5	148.4 mg/dl Standard Deviation 39.8	140.9 mg/dl Standard Deviation 38.8	144.9 mg/dl Standard Deviation 45.3
7-point Self-measured Plasma Glucose Profiles Week 16 - 90 minutes after dinner	195.0 mg/dl Standard Deviation 52.2	183.3 mg/dl Standard Deviation 46.2	173.2 mg/dl Standard Deviation 48.3	192.6 mg/dl Standard Deviation 53.8
7-point Self-measured Plasma Glucose Profiles Week 16 - Bedtime	166.4 mg/dl Standard Deviation 50.6	159.8 mg/dl Standard Deviation 44.7	151.6 mg/dl Standard Deviation 40.3	157.7 mg/dl Standard Deviation 47.6

SECONDARY outcome

Timeframe: week 0, week 16

Population: The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Change in beta cell function from baseline (week 0) to 16 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	Lira 0.6 + Met n=216 Participants Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met n=216 Participants Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met n=213 Participants Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met n=222 Participants Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
Change in Beta-cell Function	15.3 percentage point (%point) Standard Deviation 94.6	17.8 percentage point (%point) Standard Deviation 30.4	21.7 percentage point (%point) Standard Deviation 78.5	21.8 percentage point (%point) Standard Deviation 43.1

SECONDARY outcome

Timeframe: week 0, week 16

Population: The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on: * Total Cholesterol (TC) * Low-density Lipoprotein-cholesterol (LDL-C) * Very Low-density Lipoprotein-cholesterol (VLDL-C) * High-density Lipoprotein-cholesterol (HDL-C) * Triglyceride (TG) * Free Fatty Acid (FFA)

Outcome measures

Outcome measures
Measure	Lira 0.6 + Met n=231 Participants Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met n=233 Participants Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met n=233 Participants Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met n=231 Participants Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
Change in Fasting Lipid Profile Change in TC (Absolute), N=221, 216, 216, 228	0.06 mmol/L Standard Deviation 0.74	-0.01 mmol/L Standard Deviation 0.77	-0.03 mmol/L Standard Deviation 0.73	0.02 mmol/L Standard Deviation 0.73
Change in Fasting Lipid Profile Change in LDL-C (Absolute), N=221, 216, 216, 228	0.06 mmol/L Standard Deviation 0.61	-0.03 mmol/L Standard Deviation 0.64	0.00 mmol/L Standard Deviation 0.58	0.04 mmol/L Standard Deviation 0.55
Change in Fasting Lipid Profile Change in VLDL-C (Absolute), N=213, 210, 207, 220	0.03 mmol/L Standard Deviation 0.35	0.05 mmol/L Standard Deviation 0.40	0.01 mmol/L Standard Deviation 0.35	0.05 mmol/L Standard Deviation 0.42
Change in Fasting Lipid Profile Change in HDL-C (Absolute), N=217, 212, 212, 220	-0.02 mmol/L Standard Deviation 0.19	-0.05 mmol/L Standard Deviation 0.34	-0.05 mmol/L Standard Deviation 0.15	-0.01 mmol/L Standard Deviation 0.34
Change in Fasting Lipid Profile Change in TG (Absolute), N=220, 212, 213, 226	-0.08 mmol/L Standard Deviation 0.96	-0.06 mmol/L Standard Deviation 1.13	-0.22 mmol/L Standard Deviation 1.57	-0.07 mmol/L Standard Deviation 1.26
Change in Fasting Lipid Profile Change in FFA (Absolute), N=218, 214, 216, 227	-0.03 mmol/L Standard Deviation 0.28	-0.04 mmol/L Standard Deviation 0.28	-0.10 mmol/L Standard Deviation 0.28	-0.02 mmol/L Standard Deviation 0.28

SECONDARY outcome

Timeframe: week 0, week 16

Population: The Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).

Outcome measures

Outcome measures
Measure	Lira 0.6 + Met n=221 Participants Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met n=216 Participants Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met n=216 Participants Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met n=228 Participants Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
Change in Fasting Lipid Profile, APO-B	0.02 g/L Standard Deviation 0.17	0.00 g/L Standard Deviation 0.18	-0.00 g/L Standard Deviation 0.16	0.01 g/L Standard Deviation 0.17

SECONDARY outcome

Timeframe: weeks 0-16

Population: Safety Analysis Set is all randomised subjects who have been exposed to at least one dose of study products.

Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). 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	Lira 0.6 + Met n=231 Participants Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met n=233 Participants Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met n=233 Participants Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met n=231 Participants Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
Hypoglycaemic Episodes Major	0 episodes	0 episodes	0 episodes	2 episodes
Hypoglycaemic Episodes Minor	6 episodes	0 episodes	5 episodes	80 episodes
Hypoglycaemic Episodes Symptoms only	12 episodes	11 episodes	9 episodes	86 episodes

Adverse Events

Lira 0.6 + Met

Serious events: 4 serious events

Other events: 67 other events

Deaths: 0 deaths

Lira 1.2 + Met

Serious events: 8 serious events

Other events: 98 other events

Deaths: 0 deaths

Lira 1.8 + Met

Serious events: 4 serious events

Other events: 113 other events

Deaths: 0 deaths

Glim + Met

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lira 0.6 + Met n=231 participants at risk Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met n=233 participants at risk Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met n=233 participants at risk Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met n=231 participants at risk Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
Gastrointestinal disorders Diarrhoea	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Gastrointestinal disorders Gastritis	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Gastrointestinal disorders Vomiting	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Gastrointestinal disorders Abdominal pain	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Gastrointestinal disorders Nausea	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Cardiac disorders Angina pectoris	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/231 • Number of events 2 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Cardiac disorders Adams-Stokes syndrome	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Cardiac disorders Angina unstable	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Cardiac disorders Cardiac failure congestive	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Cardiac disorders Myocardial infarction	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Injury, poisoning and procedural complications Fall	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Nervous system disorders Brain injury	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Nervous system disorders Cerebellar infarction	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Nervous system disorders Cerebellar haemorrhage	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Nervous system disorders Cubital tunnel syndrome	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Infections and infestations Epiglottitis	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Infections and infestations Gastroenteritis	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Infections and infestations Upper respiratory tract infection	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign hydatidiform mole	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Endocrine disorders Hyperthyroidism	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
General disorders Fatigue	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/233 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Hepatobiliary disorders Cryptogenic cirrhosis	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/233 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.00% 0/231 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.

Other adverse events

Other adverse events
Measure	Lira 0.6 + Met n=231 participants at risk Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.2 + Met n=233 participants at risk Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Lira 1.8 + Met n=233 participants at risk Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo	Glim + Met n=231 participants at risk Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
Gastrointestinal disorders Diarrhoea	12.1% 28/231 • Number of events 29 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	15.5% 36/233 • Number of events 43 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	17.2% 40/233 • Number of events 50 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	8.7% 20/231 • Number of events 25 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Gastrointestinal disorders Nausea	12.6% 29/231 • Number of events 33 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	13.7% 32/233 • Number of events 36 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	16.3% 38/233 • Number of events 40 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	2.2% 5/231 • Number of events 5 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Gastrointestinal disorders Vomiting	7.4% 17/231 • Number of events 18 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	9.4% 22/233 • Number of events 22 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	14.2% 33/233 • Number of events 35 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	1.7% 4/231 • Number of events 4 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Gastrointestinal disorders Dyspepsia	3.0% 7/231 • Number of events 7 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	6.9% 16/233 • Number of events 17 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	5.2% 12/233 • Number of events 13 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Metabolism and nutrition disorders Anorexia	3.0% 7/231 • Number of events 7 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	14.2% 33/233 • Number of events 33 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	15.0% 35/233 • Number of events 35 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	1.7% 4/231 • Number of events 4 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
Metabolism and nutrition disorders Decreased appetite	4.3% 10/231 • Number of events 10 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	5.2% 12/233 • Number of events 12 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	3.0% 7/233 • Number of events 7 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	0.43% 1/231 • Number of events 1 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.
General disorders Asthenia	1.7% 4/231 • Number of events 4 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	4.3% 10/233 • Number of events 10 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	5.2% 12/233 • Number of events 14 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.	1.3% 3/231 • Number of events 3 • The adverse events were collected over a time span of 16 weeks. The safety analysis set is all who had been exposed to at least one dose of the study products.

Additional Information

Public Access to Clinical Trials

Novo Nordisk A/S

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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 and 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.
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