Trial Outcomes & Findings for The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes (NCT NCT02098395)

NCT ID: NCT02098395

Last Updated: 2017-02-09

Results Overview

Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 835 participants
• Primary outcome timeframe: Week 0, Week 26
• Results posted on: 2017-02-09

Participant Flow

Subjects were randomised at 113 sites in 13 countries: Austria 2 sites, Belgium 9 sites, Bulgaria 5 sites, Canada 9 sites, Denmark 4 sites, Finland 6 sites, France 9 sites, Italy 7 sites, Netherlands 5 sites, South Africa 2 sites, Spain 5 sites, Sweden 5 sites, United States 45 sites.

Participant milestones

Measure	Liraglutide 0.6 mg Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.2 mg Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.8 mg Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide Placebo Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis. 1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial. 2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks. 3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.
Overall Study STARTED	212	209	207	207
Overall Study Exposed	211	209	206	206
Overall Study COMPLETED	186	177	165	180
Overall Study NOT COMPLETED	26	32	42	27

Reasons for withdrawal

Measure	Liraglutide 0.6 mg Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.2 mg Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.8 mg Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide Placebo Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis. 1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial. 2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks. 3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.
Overall Study Protocol Violation	2	2	0	7
Overall Study Withdrawal by Subject	10	10	5	13
Overall Study Adverse Event	12	19	34	2
Overall Study Lost to Follow-up	2	1	0	3
Overall Study Unclassified	0	0	3	2

Baseline Characteristics

The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes

Baseline characteristics by cohort

Measure	Liraglutide 0.6 mg n=211 Participants Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.2 mg n=209 Participants Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.8 mg n=205 Participants Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide Placebo n=206 Participants Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis. 1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial. 2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks. 3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.	Total n=831 Participants Total of all reporting groups
Age, Continuous	43.9 years STANDARD_DEVIATION 12.88 • n=5 Participants	42.8 years STANDARD_DEVIATION 13.31 • n=7 Participants	43.2 years STANDARD_DEVIATION 12.9 • n=5 Participants	42.7 years STANDARD_DEVIATION 12.97 • n=4 Participants	43.2 years STANDARD_DEVIATION 13.00 • n=21 Participants
Gender Female	118 Participants n=5 Participants	106 Participants n=7 Participants	113 Participants n=5 Participants	112 Participants n=4 Participants	449 Participants n=21 Participants
Gender Male	93 Participants n=5 Participants	103 Participants n=7 Participants	92 Participants n=5 Participants	94 Participants n=4 Participants	382 Participants n=21 Participants
Glycosylated Haemoglobin (HbA1c)	8.09 Percent (%) glycosylated haemoglobin STANDARD_DEVIATION 0.743 • n=5 Participants	8.07 Percent (%) glycosylated haemoglobin STANDARD_DEVIATION 0.731 • n=7 Participants	8.04 Percent (%) glycosylated haemoglobin STANDARD_DEVIATION 0.736 • n=5 Participants	8.12 Percent (%) glycosylated haemoglobin STANDARD_DEVIATION 0.723 • n=4 Participants	8.08 Percent (%) glycosylated haemoglobin STANDARD_DEVIATION 0.732 • n=21 Participants
Body Weight	83.10 kg STANDARD_DEVIATION 16.137 • n=5 Participants	84.69 kg STANDARD_DEVIATION 18.155 • n=7 Participants	83.64 kg STANDARD_DEVIATION 17.620 • n=5 Participants	84.20 kg STANDARD_DEVIATION 16.539 • n=4 Participants	83.91 kg STANDARD_DEVIATION 17.109 • n=21 Participants

PRIMARY outcome

Timeframe: Week 0, Week 26

Population: Out of the 831 subjects in FAS, 22 subjects in lira 0.6 mg arm, 33 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 16 in placebo arm did not contribute to this analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.

Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.

Outcome measures

Measure	Liraglutide 0.6 mg n=189 Participants Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.2 mg n=176 Participants Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.8 mg n=170 Participants Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide Placebo n=190 Participants Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis. 1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial. 2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks. 3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.
Change From Baseline in Glycosylated Haemoglobin (HbA1c)	-0.23 Percent (%) glycosylated haemoglobin Standard Deviation 0.744	-0.23 Percent (%) glycosylated haemoglobin Standard Deviation 0.731	-0.32 Percent (%) glycosylated haemoglobin Standard Deviation 0.73	0.01 Percent (%) glycosylated haemoglobin Standard Deviation 0.674

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: Of the 831 subjects in FAS, 27 subjects in lira 0.6 mg arm, 38 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 26 in placebo arm did not contribute to the analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.

Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.

Outcome measures

Measure	Liraglutide 0.6 mg n=184 Participants Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.2 mg n=171 Participants Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.8 mg n=170 Participants Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide Placebo n=180 Participants Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis. 1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial. 2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks. 3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.
Change From Baseline in Body Weight	-2.37 kg Standard Deviation 3.015	-4.03 kg Standard Deviation 3.677	-5.1 kg Standard Deviation 3.787	-0.26 kg Standard Deviation 2.782

SECONDARY outcome

Timeframe: Weeks 0-26

Population: Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo (SAS = 832 subjects). Symptomatic hypoglycaemic episodes were reported by 166 subjects in liraglutide 0.6 mg arm, 175 subjects in liraglutide 1.2 mg, 160 subjects in liraglutide 1.8 mg arm and 162 subjects in liraglutide placebo arm.

Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.

Outcome measures

Measure	Liraglutide 0.6 mg n=211 Participants Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.2 mg n=209 Participants Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.8 mg n=206 Participants Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide Placebo n=206 Participants Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis. 1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial. 2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks. 3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.
Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes	1437 episodes	1943 episodes	1490 episodes	1567 episodes

Adverse Events

Liraglutide 0.6 mg

Serious events: 20 serious events

Other events: 137 other events

Deaths: 0 deaths

Liraglutide 1.2 mg

Serious events: 21 serious events

Other events: 164 other events

Deaths: 0 deaths

Liraglutide 1.8 mg

Serious events: 14 serious events

Other events: 162 other events

Deaths: 0 deaths

Liraglutide Placebo

Serious events: 14 serious events

Other events: 125 other events

Deaths: 0 deaths

Serious adverse events

Measure	Liraglutide 0.6 mg n=211 participants at risk Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.2 mg n=209 participants at risk Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.8 mg n=206 participants at risk Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide Placebo n=206 participants at risk Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis. 1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial. 2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks. 3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.
Blood and lymphatic system disorders Anaemia	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Cardiac disorders Angina unstable	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Cardiac disorders Coronary artery disease	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.97% 2/206 • Number of events 2 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Cardiac disorders Myocardial infarction	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Cardiac disorders Myocardial ischaemia	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Endocrine disorders Goitre	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Gastrointestinal disorders Abdominal pain	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Gastrointestinal disorders Diarrhoea	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.96% 2/209 • Number of events 2 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Gastrointestinal disorders Nausea	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Gastrointestinal disorders Volvulus	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Gastrointestinal disorders Vomiting	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.96% 2/209 • Number of events 2 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
General disorders Chest discomfort	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
General disorders Chest pain	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
General disorders Non-cardiac chest pain	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Hepatobiliary disorders Bile duct stone	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Hepatobiliary disorders Cholecystitis	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Infections and infestations Cellulitis	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Infections and infestations Gastroenteritis	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Infections and infestations Pneumonia	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Infections and infestations Pyelonephritis	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Infections and infestations Staphylococcal infection	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Injury, poisoning and procedural complications Animal bite	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Injury, poisoning and procedural complications Forearm fracture	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Injury, poisoning and procedural complications Intervertebral disc injury	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Injury, poisoning and procedural complications Joint dislocation	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Injury, poisoning and procedural complications Ligament sprain	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Injury, poisoning and procedural complications Meniscus injury	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Injury, poisoning and procedural complications Tibia fracture	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.97% 2/206 • Number of events 2 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.97% 2/206 • Number of events 2 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Metabolism and nutrition disorders Hypoglycaemia	2.4% 5/211 • Number of events 6 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.96% 2/209 • Number of events 2 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Nervous system disorders Hypoglycaemic coma	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Nervous system disorders Hypoglycaemic unconsciousness	1.4% 3/211 • Number of events 5 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	2.9% 6/209 • Number of events 7 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.97% 2/206 • Number of events 2 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Nervous system disorders Radiculopathy	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Nervous system disorders Syncope	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Nervous system disorders Transient ischaemic attack	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Nervous system disorders VIth nerve paralysis	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Psychiatric disorders Anxiety disorder	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Psychiatric disorders Depressed mood	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Psychiatric disorders Depression	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Renal and urinary disorders Acute kidney injury	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Renal and urinary disorders Diabetic nephropathy	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Renal and urinary disorders Nephrolithiasis	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Surgical and medical procedures Wrist surgery	0.00% 0/211 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.48% 1/209 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Vascular disorders Hypertension	0.47% 1/211 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/209 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.00% 0/206 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.

Other adverse events

Measure	Liraglutide 0.6 mg n=211 participants at risk Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.2 mg n=209 participants at risk Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide 1.8 mg n=206 participants at risk Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.	Liraglutide Placebo n=206 participants at risk Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis. 1. Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial. 2. Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks. 3. Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period.
Gastrointestinal disorders Abdominal discomfort	1.4% 3/211 • Number of events 4 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	6.7% 14/209 • Number of events 18 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	3.4% 7/206 • Number of events 7 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	2.9% 6/206 • Number of events 7 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Gastrointestinal disorders Abdominal pain upper	3.8% 8/211 • Number of events 8 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	3.8% 8/209 • Number of events 13 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	6.8% 14/206 • Number of events 17 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	2.4% 5/206 • Number of events 5 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Gastrointestinal disorders Constipation	2.8% 6/211 • Number of events 6 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	11.0% 23/209 • Number of events 29 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	6.8% 14/206 • Number of events 15 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	4.4% 9/206 • Number of events 12 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Gastrointestinal disorders Diarrhoea	6.6% 14/211 • Number of events 17 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	12.0% 25/209 • Number of events 30 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	14.6% 30/206 • Number of events 43 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	8.3% 17/206 • Number of events 22 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Gastrointestinal disorders Dyspepsia	3.8% 8/211 • Number of events 9 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	9.1% 19/209 • Number of events 23 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	11.7% 24/206 • Number of events 35 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	0.49% 1/206 • Number of events 1 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Gastrointestinal disorders Nausea	32.2% 68/211 • Number of events 81 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	46.4% 97/209 • Number of events 122 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	49.5% 102/206 • Number of events 170 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	16.5% 34/206 • Number of events 40 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Gastrointestinal disorders Vomiting	9.0% 19/211 • Number of events 25 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	13.9% 29/209 • Number of events 40 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	17.0% 35/206 • Number of events 65 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	3.4% 7/206 • Number of events 8 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
General disorders Fatigue	6.2% 13/211 • Number of events 13 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	8.1% 17/209 • Number of events 18 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	10.7% 22/206 • Number of events 25 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	1.5% 3/206 • Number of events 5 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Infections and infestations Gastroenteritis	2.8% 6/211 • Number of events 7 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	5.3% 11/209 • Number of events 11 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	3.9% 8/206 • Number of events 9 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	2.9% 6/206 • Number of events 6 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Infections and infestations Influenza	7.1% 15/211 • Number of events 15 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	8.6% 18/209 • Number of events 23 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	8.7% 18/206 • Number of events 19 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	8.3% 17/206 • Number of events 20 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Infections and infestations Nasopharyngitis	20.9% 44/211 • Number of events 59 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	19.1% 40/209 • Number of events 52 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	22.8% 47/206 • Number of events 67 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	22.3% 46/206 • Number of events 56 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Infections and infestations Sinusitis	3.3% 7/211 • Number of events 7 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	5.3% 11/209 • Number of events 12 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	1.5% 3/206 • Number of events 3 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	1.9% 4/206 • Number of events 4 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Infections and infestations Upper respiratory tract infection	6.6% 14/211 • Number of events 20 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	5.3% 11/209 • Number of events 13 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	5.3% 11/206 • Number of events 14 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	12.1% 25/206 • Number of events 31 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Metabolism and nutrition disorders Decreased appetite	10.0% 21/211 • Number of events 21 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	19.1% 40/209 • Number of events 42 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	24.3% 50/206 • Number of events 55 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	4.4% 9/206 • Number of events 10 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Metabolism and nutrition disorders Hyperglycaemia	4.7% 10/211 • Number of events 14 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	6.2% 13/209 • Number of events 17 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	5.8% 12/206 • Number of events 16 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	1.9% 4/206 • Number of events 4 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Musculoskeletal and connective tissue disorders Back pain	1.4% 3/211 • Number of events 4 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	2.4% 5/209 • Number of events 6 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	3.9% 8/206 • Number of events 10 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	6.8% 14/206 • Number of events 15 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Nervous system disorders Headache	7.6% 16/211 • Number of events 27 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	12.4% 26/209 • Number of events 33 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	14.6% 30/206 • Number of events 43 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	14.6% 30/206 • Number of events 40 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.7% 10/211 • Number of events 12 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	1.9% 4/209 • Number of events 4 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	6.8% 14/206 • Number of events 19 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.	2.9% 6/206 • Number of events 10 • From the first day of exposure to randomised treatment (week 0) to 7 days after the last day of randomised treatment (week 26). Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo.

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