Trial Outcomes & Findings for Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes (NCT NCT01541215)

Results Overview

Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

135 participants

Primary outcome timeframe

Week 0, week 26

Results posted on

2021-07-02

Participant Flow

The trial was conducted at 84 sites in 25 countries.

Eligible subjects entered an 11- to 12-week run-in period where they were to undergo a 3-4 week titration of metformin to a maximum tolerated dose of metformin (≥1000 mg and ≤2000 mg per day) followed by an 8-week maintenance period.

Participant milestones

Participant milestones
Measure	Liraglutide 1.8 mg After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Treatment Period (52 Weeks) STARTED	66	69
Treatment Period (52 Weeks) Exposed	66	68
Treatment Period (52 Weeks) COMPLETED	56	53
Treatment Period (52 Weeks) NOT COMPLETED	10	16
Follow up 1 (Weeks 53-104) STARTED	52	0
Follow up 1 (Weeks 53-104) COMPLETED	50	0
Follow up 1 (Weeks 53-104) NOT COMPLETED	2	0
Follow up 2 (Weeks 105-156) STARTED	48	0
Follow up 2 (Weeks 105-156) COMPLETED	48	0
Follow up 2 (Weeks 105-156) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Liraglutide 1.8 mg After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.
Treatment Period (52 Weeks) Withdrawal criteria	6	8
Treatment Period (52 Weeks) Non-compliance	4	4
Treatment Period (52 Weeks) Adverse Event	0	1
Treatment Period (52 Weeks) Unclassified	0	3
Follow up 1 (Weeks 53-104) Lost to Follow-up	1	0
Follow up 1 (Weeks 53-104) Withdrawal by Subject	1	0

Baseline Characteristics

Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liraglutide 1.8 mg n=66 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).	Placebo n=68 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Total n=134 Participants Total of all reporting groups
Age, Continuous	14.57 years STANDARD_DEVIATION 1.73 • n=5 Participants	14.57 years STANDARD_DEVIATION 1.73 • n=7 Participants	14.57 years STANDARD_DEVIATION 1.72 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	42 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	45 Participants n=7 Participants	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	45 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Glycosylated hemoglobin (HbA1c)	7.87 percentage of HbA1c STANDARD_DEVIATION 1.35 • n=5 Participants	7.69 percentage of HbA1c STANDARD_DEVIATION 1.34 • n=7 Participants	7.78 percentage of HbA1c STANDARD_DEVIATION 1.34 • n=5 Participants

PRIMARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set.

Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=66 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in HbA1c (Glycosylated Haemoglobin)	0.415 Percentage of HbA1c Standard Error 0.216	-0.643 Percentage of HbA1c Standard Error 0.215

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set.

Change in FPG from baseline to week 26. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=66 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Baseline in Fasting Plasma Glucose (FPG)	0.801 mmol/L Standard Error 0.449	-1.076 mmol/L Standard Error 0.436

SECONDARY outcome

Timeframe: Week 26

Population: Full analysis set.

Percentage of subjects having HbA1c \<7.0%. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=66 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Subjects Having HbA1c Below 7.0%	36.5 Percentage of subjects	63.7 Percentage of subjects

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set.

Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=66 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)	-0.208 SDS score Standard Error 0.039	-0.254 SDS score Standard Error 0.039

SECONDARY outcome

Timeframe: Week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Number of subjects achieving HbA1c \<7.0% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Subjects Having HbA1c Below 7.0% Yes	16 Participants	27 Participants
Number of Subjects Having HbA1c Below 7.0% No	36 Participants	29 Participants

SECONDARY outcome

Timeframe: Week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Number of subjects achieving HbA1c \<=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=59 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Subjects Having HbA1c Maximum 6.5% Yes	19 Participants	28 Participants
Number of Subjects Having HbA1c Maximum 6.5% No	39 Participants	31 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Number of subjects achieving HbA1c \<=6.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Subjects Having HbA1c Maximum 6.5% Yes	13 Participants	25 Participants
Number of Subjects Having HbA1c Maximum 6.5% No	39 Participants	31 Participants

SECONDARY outcome

Timeframe: Week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Number of subjects achieving HbA1c \<7.0% without severe or minor hypoglycaemic episodes after 26 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria: 1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself 2. any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=59 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes Yes	21 Participants	31 Participants
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes No	37 Participants	28 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Number of subjects achieving HbA1c \<7.0% without severe or minor hypoglycaemic episodes after 52 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria: 1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself 2. any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes Yes	16 Participants	22 Participants
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes No	36 Participants	34 Participants

SECONDARY outcome

Timeframe: Week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Number of subjects achieving HbA1c \<7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=59 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Subjects Having HbA1c Below 7.5% Yes	29 Participants	43 Participants
Number of Subjects Having HbA1c Below 7.5% No	29 Participants	16 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Number of subjects achieving HbA1c \<7.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Subjects Having HbA1c Below 7.5% Yes	23 Participants	36 Participants
Number of Subjects Having HbA1c Below 7.5% No	29 Participants	20 Participants

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in HbA1c	0.677 percentage of HbA1c Standard Deviation 1.523	-0.732 percentage of HbA1c Standard Deviation 1.423

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in FPG	0.983 mmol/L Standard Deviation 3.954	-1.627 mmol/L Standard Deviation 2.717

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=39 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in Mean 7-point Self-measured Plasma Glucose	0.198 mmol/L Standard Deviation 2.056	-2.384 mmol/L Standard Deviation 2.638

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=39 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=41 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Baseline in 7-point Self-measured Plasma Glucose	-0.748 mmol/L Standard Deviation 1.944	-2.309 mmol/L Standard Deviation 2.968

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of analysed=participants with available data for specified timepoints.

Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=41 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) Breakfast	-0.319 mmol/L Standard Deviation 3.228	-1.528 mmol/L Standard Deviation 3.168
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) Lunch	-0.658 mmol/L Standard Deviation 3.421	-0.358 mmol/L Standard Deviation 3.281
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) Dinner	-0.226 mmol/L Standard Deviation 2.806	0.397 mmol/L Standard Deviation 3.790

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of analysed=participants with available data for specified timepoints.

Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=38 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=42 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) Breakfast	0.053 mmol/L Standard Deviation 2.124	-1.802 mmol/L Standard Deviation 3.338
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) Lunch	-1.219 mmol/L Standard Deviation 3.038	-0.735 mmol/L Standard Deviation 3.809
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner) Dinner	-0.195 mmol/L Standard Deviation 2.803	-0.028 mmol/L Standard Deviation 3.501

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of analysed=participants with available data.

Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=40 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)	-0.362 mmol/L Standard Deviation 1.733	-0.428 mmol/L Standard Deviation 2.172

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of analysed=participants with available data.

Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=39 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=41 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)	-0.397 mmol/L Standard Deviation 1.594	-0.747 mmol/L Standard Deviation 2.245

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=60 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Baseline in Body Weight	-0.87 kg Standard Deviation 3.84	-2.48 kg Standard Deviation 5.59

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Change from baseline in body weight after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Baseline in Body Weight	1.02 kg Standard Deviation 4.64	-2.27 kg Standard Deviation 8.05

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Baseline in BMI Standard Deviation Score (SDS)	-0.166 SDS score Standard Deviation 0.330	-0.361 SDS score Standard Deviation 0.542

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=60 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Systolic Blood Pressure	0.03 mmHg Standard Deviation 10.05	-1.65 mmHg Standard Deviation 10.69
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Diastolic Blood Pressure	0.97 mmHg Standard Deviation 7.65	-1.27 mmHg Standard Deviation 8.39

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Systolic Blood Pressure	2.81 mmHg Standard Deviation 8.48	-0.77 mmHg Standard Deviation 11.77
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Diastolic Blood Pressure	1.83 mmHg Standard Deviation 7.26	0.46 mmHg Standard Deviation 10.01

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=59 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Fasting Insulin	1.0 ratio Geometric Coefficient of Variation 77.9	0.9 ratio Geometric Coefficient of Variation 76.4

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (fasting insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=54 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Fasting Insulin	1.1 ratio Geometric Coefficient of Variation 142.8	1.0 ratio Geometric Coefficient of Variation 80.6

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=55 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Fasting Pro-insulin	0.88 ratio Geometric Coefficient of Variation 131.6	0.62 ratio Geometric Coefficient of Variation 110.3

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (fasting pro-insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=54 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Fasting Pro-insulin	0.79 ratio Geometric Coefficient of Variation 121.0	0.62 ratio Geometric Coefficient of Variation 118.0

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=55 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Pro-insulin/Insulin Ratio	0.923 ratio Geometric Coefficient of Variation 197.6	0.690 ratio Geometric Coefficient of Variation 102.4

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (Pro-insulin/insulin ratio) after week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=53 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Pro-insulin/Insulin Ratio	0.770 ratio Geometric Coefficient of Variation 225.1	0.689 ratio Geometric Coefficient of Variation 106.6

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=60 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Fasting Glucagon	1.03 ratio Geometric Coefficient of Variation 32.4	0.98 ratio Geometric Coefficient of Variation 29.3

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (fasting glucagon) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=54 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Fasting Glucagon	1.05 ratio Geometric Coefficient of Variation 32.7	1.01 ratio Geometric Coefficient of Variation 35.0

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=59 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Fasting C-peptide	0.84 ratio Geometric Coefficient of Variation 82.3	0.93 ratio Geometric Coefficient of Variation 39.7

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (fasting C-peptide) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=54 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Fasting C-peptide	0.83 ratio Geometric Coefficient of Variation 56.5	0.94 ratio Geometric Coefficient of Variation 40.8

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)	1.01 ratio Geometric Coefficient of Variation 119.0	1.24 ratio Geometric Coefficient of Variation 96.9

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=51 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: HOMA-B	0.93 ratio Geometric Coefficient of Variation 166.8	1.48 ratio Geometric Coefficient of Variation 105.0

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=58 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)	0.98 ratio Geometric Coefficient of Variation 80.8	0.73 ratio Geometric Coefficient of Variation 80.5

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=53 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: HOMA-IR	1.08 ratio Geometric Coefficient of Variation 140.3	0.82 ratio Geometric Coefficient of Variation 86.4

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=60 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Total Cholesterol	1.008 ratio Geometric Coefficient of Variation 13.3	0.975 ratio Geometric Coefficient of Variation 17.7

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (total cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=52 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Total Cholesterol	1.026 ratio Geometric Coefficient of Variation 13.5	1.013 ratio Geometric Coefficient of Variation 21.0

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=58 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol	0.993 ratio Geometric Coefficient of Variation 20.4	0.998 ratio Geometric Coefficient of Variation 24.8

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=54 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: LDL Cholesterol	1.035 ratio Geometric Coefficient of Variation 21.5	1.042 ratio Geometric Coefficient of Variation 46.3

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=59 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol	1.035 ratio Geometric Coefficient of Variation 35.3	0.890 ratio Geometric Coefficient of Variation 51.6

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: VLDL Cholesterol	1.003 ratio Geometric Coefficient of Variation 45.5	0.983 ratio Geometric Coefficient of Variation 48.4

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=59 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol	0.981 ratio Geometric Coefficient of Variation 16.3	0.997 ratio Geometric Coefficient of Variation 18.7

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: HDL Cholesterol	1.000 ratio Geometric Coefficient of Variation 18.8	1.028 ratio Geometric Coefficient of Variation 16.0

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=60 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Triglycerides	1.038 ratio Geometric Coefficient of Variation 36.0	0.894 ratio Geometric Coefficient of Variation 50.6

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (triglycerides) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Triglycerides	1.036 ratio Geometric Coefficient of Variation 48.4	0.964 ratio Geometric Coefficient of Variation 50.5

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=59 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Free Fatty Acids	0.985 ratio Geometric Coefficient of Variation 47.5	1.023 ratio Geometric Coefficient of Variation 67.4

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Full analysis set. Number of participants analysed=participants with available data.

Ratio to baseline (free fatty acids) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=54 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Ratio to Baseline: Free Fatty Acids	0.868 ratio Geometric Coefficient of Variation 54.8	0.928 ratio Geometric Coefficient of Variation 58.2

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Safety analysis set - included all subjects receiving at least one dose of liraglutide/placebo (134 subjects). Number of participants analysed=participants with available data.

Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=60 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Baseline in Pulse	0.33 beats/minute Standard Deviation 7.69	1.40 beats/minute Standard Deviation 10.89

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Safety analysis set. Number of participants analysed=participants with available data.

Change from baseline in pulse 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Baseline in Pulse	-0.28 beats/minute Standard Deviation 7.88	-0.05 beats/minute Standard Deviation 10.39

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Safety analysis set. Number of participants analysed=participants with available data.

Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=60 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Baseline in Height SDS	-0.042 SDS score Standard Deviation 0.210	-0.100 SDS score Standard Deviation 0.133

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Safety analysis set. Number of participants analysed=participants with available data.

Change in height SDS from baseline to week 52. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Baseline in Height SDS	-0.134 SDS score Standard Deviation 0.293	-0.192 SDS score Standard Deviation 0.223

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Safety analysis set. Number of participants analysed=participants with available data.

Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=31 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in Bone Age Assessment (X-ray of Left Hand and Wrist)	1.088 years Standard Deviation 0.889	1.197 years Standard Deviation 0.899

SECONDARY outcome

Timeframe: Week 0, week 26, week 52

Population: Safety analysis set. Number of participants analysed=participants with available data

Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=66 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 26 · Stage IV	10 Participants	5 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 0 · Stage I	0 Participants	1 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 0 · Stage II	0 Participants	2 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 0 · Stage III	10 Participants	4 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 0 · Stage IV	9 Participants	8 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 0 · Stage V	23 Participants	26 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 26 · Stage I	0 Participants	0 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 26 · Stage II	0 Participants	1 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 26 · Stage III	4 Participants	2 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 26 · Stage V	22 Participants	29 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 52 · Stage I	0 Participants	0 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 52 · Stage II	0 Participants	0 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 52 · Stage III	2 Participants	1 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 52 · Stage IV	9 Participants	5 Participants
Pubertal Assessment/Progression (Tanner Staging) Female - Breast development - Week 52 · Stage V	22 Participants	27 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 0 · Stage I	0 Participants	2 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 0 · Stage II	3 Participants	1 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 0 · Stage III	6 Participants	2 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 0 · Stage IV	11 Participants	9 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 0 · Stage V	6 Participants	11 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 26 · Stage I	0 Participants	2 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 26 · Stage II	1 Participants	1 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 52 · Stage IV	6 Participants	7 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 52 · Stage V	13 Participants	15 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 0 · Stage I	3 Participants	3 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 0 · Stage II	0 Participants	3 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 0 · Stage III	10 Participants	8 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 0 · Stage IV	25 Participants	14 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 0 · Stage V	29 Participants	38 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 26 · Stage I	0 Participants	3 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 26 · Stage II	2 Participants	0 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 26 · Stage III	4 Participants	5 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 26 · Stage IV	18 Participants	11 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 26 · Stage V	34 Participants	43 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 52 · Stage I	0 Participants	1 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 52 · Stage II	0 Participants	1 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 52 · Stage III	2 Participants	4 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 52 · Stage IV	17 Participants	8 Participants
Pubertal Assessment/Progression (Tanner Staging) Pubic Hair Development - Week 52 · Stage V	34 Participants	43 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 26 · Stage III	4 Participants	2 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 26 · Stage IV	8 Participants	7 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 26 · Stage V	10 Participants	13 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 52 · Stage I	0 Participants	1 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 52 · Stage II	0 Participants	2 Participants
Pubertal Assessment/Progression (Tanner Staging) Male - Penis Development - Week 52 · Stage III	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Safety analysis set. Number of participants analysed=participants with available data.

Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=60 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Growth (Height Velocity)	2.486 cm/year Standard Deviation 2.834	1.633 cm/year Standard Deviation 2.016

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Safety analysis set. Number of participants analysed=participants with available data.

Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=56 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Growth (Height Velocity)	1.817 cm/year Standard Deviation 2.043	1.345 cm/year Standard Deviation 1.730

SECONDARY outcome

Timeframe: Week 0, week 26

Population: Safety analysis set. Number of participants analysed=participants with available data.

Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=58 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=60 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Height Velocity SDS	-0.557 SDS score Standard Deviation 2.058	-1.24 SDS score Standard Deviation 1.695

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Safety analysis set. Number of participants analysed=participants with available data.

Height velocity SDS scores at week 52. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=52 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Height Velocity SDS	-0.551 SDS score Standard Deviation 1.711	-0.887 SDS score Standard Deviation 1.460

SECONDARY outcome

Timeframe: 0-26 weeks

Population: Safety analysis set

Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=66 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Hypoglycaemic Episodes	43 hypoglycaemic episodes	92 hypoglycaemic episodes

SECONDARY outcome

Timeframe: 0-52 weeks

Population: Safety analysis set

Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=66 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Hypoglycaemic Episodes	63 hypoglycaemic episodes	160 hypoglycaemic episodes

SECONDARY outcome

Timeframe: 0-26 weeks

Population: Safety analysis set

Total number of adverse events during 26 weeks.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=66 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Adverse Events (Week 0-26)	230 events	310 events

SECONDARY outcome

Timeframe: 0-52 weeks

Population: Safety analysis set

Total number of adverse events during entire treatment period.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=66 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Adverse Events (Week 0-52)	321 events	426 events

SECONDARY outcome

Timeframe: 0-26 weeks

Population: Safety analysis set

Total number of serious adverse events during 26 weeks.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=66 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Serious Adverse Events (Week 0-26)	4 events	7 events

SECONDARY outcome

Timeframe: 0-52 weeks

Population: Safety analysis set

Total number of serious adverse events during entire treatment period.

Outcome measures

Outcome measures
Measure	Placebo n=68 Participants After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=66 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Serious Adverse Events (Week 0-52)	5 events	10 events

SECONDARY outcome

Timeframe: Week 53-104

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104.

This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during follow-up 1 (week 53 to 104).

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=52 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Adverse Events (Week 53-104)	—	30 events

SECONDARY outcome

Timeframe: Weeks 53-104

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104.

This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during follow up 1 (week 53 to 104).

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=52 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Serious Adverse Events (Week 53-104)	—	7 events

SECONDARY outcome

Timeframe: Week 0, week 104

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.

Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=50 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Growth (Height Velocity)- Week 104	—	1.149 cm/year Standard Deviation 1.776

SECONDARY outcome

Timeframe: Week 0, week 104

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.

The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=41 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Height Velocity SDS- Week 104	—	-0.523 SDS score Standard Deviation 1.466

SECONDARY outcome

Timeframe: Week 52, week 104

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.

Change in height SDS from week 52 to week 104. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=49 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Week 52 in Height SDS- Week 104	—	-0.133 SDS score Standard Deviation 0.338

SECONDARY outcome

Timeframe: Week 52, week 104

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Number analyzed= subjects with available data.

Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=52 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Breast development- Week 52 · Stage I	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Breast development- Week 52 · Stage II	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Breast development- Week 52 · Stage III	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Breast development- Week 52 · Stage V	—	21 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Breast development- Week 104 · Stage I	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Breast development- Week 104 · Stage IV	—	5 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Breast development- Week 104 · Stage V	—	11 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Penis development- Week 52 · Stage I	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Penis development- Week 52 · Stage III	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Penis development- Week 52 · Stage IV	—	7 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Penis development- Week 52 · Stage V	—	14 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Penis development- Week 104 · Stage I	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Penis development- Week 104 · Stage II	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Penis development- Week 104 · Stage III	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Pubic hair development- Week 52 · Stage I	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Pubic hair development- Week 52 · Stage V	—	22 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Pubic hair development- Week 104 · Stage I	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Pubic hair development- Week 104 · Stage II	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Pubic hair development- Week 104 · Stage III	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Pubic hair development- Week 104 · Stage V	—	13 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Pubic hair development- Week 52 · Stage I	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Pubic hair development- Week 52 · Stage III	—	2 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Pubic hair development- Week 52 · Stage IV	—	6 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Breast development- Week 52 · Stage IV	—	5 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Breast development- Week 104 · Stage II	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Breast development- Week 104 · Stage III	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Penis development- Week 52 · Stage II	—	2 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Penis development- Week 104 · Stage IV	—	5 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Penis development- Week 104 · Stage V	—	8 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Pubic hair development- Week 52 · Stage II	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Pubic hair development- Week 52 · Stage III	—	2 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Pubic hair development- Week 52 · Stage IV	—	2 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Female- Pubic hair development- Week 104 · Stage IV	—	2 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Pubic hair development- Week 52 · Stage II	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Pubic hair development- Week 52 · Stage V	—	14 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Pubic hair development- Week 104 · Stage I	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Pubic hair development- Week 104 · Stage II	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Pubic hair development- Week 104 · Stage III	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Pubic hair development- Week 104 · Stage IV	—	4 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104 Male- Pubic hair development- Week 104 · Stage V	—	9 Participants

SECONDARY outcome

Timeframe: Week 52, week 104

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-104. Overall number of participants analyzed= subjects with available data.

Change in bone age from week 52 to week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=13 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104	—	1.231 Years Standard Deviation 0.992

SECONDARY outcome

Timeframe: Week 53-156

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during weeks 53-156.

This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during the follow-up period (weeks 53 to 156).

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=52 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Adverse Events (Week 53-156)	—	47 events

SECONDARY outcome

Timeframe: Weeks 53-156

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during weeks 53-156.

This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during the follow up period (week 53 to 156).

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=52 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Number of Serious Adverse Events (Week 53-156)	—	9 events

SECONDARY outcome

Timeframe: Week 0, week 156

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.

Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=45 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Growth (Height Velocity)- Week 156	—	1.100 cm/year Standard Deviation 1.504

SECONDARY outcome

Timeframe: Week 0, week 156

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.

The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=27 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Height Velocity SDS- Week 156	—	0.142 SDS score Standard Deviation 1.156

SECONDARY outcome

Timeframe: Week 52, week 156

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.

Change in height SDS from week 52 to week 156. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=36 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Week 52 in Height SDS- Week 156	—	-0.224 SDS score Standard Deviation 0.446

SECONDARY outcome

Timeframe: Week 52, week 156

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Number analyzed= subjects with available data.

Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=52 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Breast development- Week 156 · Stage II	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Penis development- Week 52 · Stage III	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Pubic hair development- Week 52 · Stage II	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Pubic hair development- Week 52 · Stage III	—	2 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Pubic hair development- Week 156 · Stage IV	—	2 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Pubic hair development- Week 156 · Stage V	—	11 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Pubic hair development- Week 156 · Stage I	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Pubic hair development- Week 156 · Stage II	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Breast development- Week 52 · Stage I	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Breast development- Week 52 · Stage II	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Breast development- Week 52 · Stage III	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Breast development- Week 52 · Stage IV	—	5 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Breast development- Week 52 · Stage V	—	21 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Breast development- Week 156 · Stage I	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Breast development- Week 156 · Stage III	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Breast development- Week 156 · Stage IV	—	3 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Breast development- Week 156 · Stage V	—	11 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Penis development- Week 52 · Stage I	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Penis development- Week 52 · Stage II	—	2 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Penis development- Week 52 · Stage IV	—	7 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Penis development- Week 52 · Stage V	—	14 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Penis development- Week 156 · Stage I	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Penis development- Week 156 · Stage II	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Penis development- Week 156 · Stage III	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Penis development- Week 156 · Stage IV	—	3 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Penis development- Week 156 · Stage V	—	9 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Pubic hair development- Week 52 · Stage I	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Pubic hair development- Week 52 · Stage IV	—	2 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Pubic hair development- Week 52 · Stage V	—	22 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Pubic hair development- Week 156 · Stage I	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Pubic hair development- Week 156 · Stage II	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Female- Pubic hair development- Week 156 · Stage III	—	0 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Pubic hair development- Week 52 · Stage I	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Pubic hair development- Week 52 · Stage II	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Pubic hair development- Week 52 · Stage III	—	2 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Pubic hair development- Week 52 · Stage IV	—	6 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Pubic hair development- Week 52 · Stage V	—	14 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Pubic hair development- Week 156 · Stage III	—	1 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Pubic hair development- Week 156 · Stage IV	—	3 Participants
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156 Male- Pubic hair development- Week 156 · Stage V	—	10 Participants

SECONDARY outcome

Timeframe: Week 52, week 156

Population: Safety analysis set- Subjects who received liraglutide for more than 3 months during the treatment period (week 0-52) and provided safety follow-up data anytime during week 53-156. Overall number of participants analyzed= subjects with available data at week 156.

Change in bone age from week 52 to week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.

Outcome measures

Outcome measures
Measure	Placebo After the run-in period, subjects were randomized to receive placebo (in combination with metformin with or without basal insulin, on a background of diet and exercise) for a 26 weeks double blind treatment period. The liraglutide placebo was administered once daily subcutaneously in equivalent volume as liraglutide. After 26 weeks, participants discontinued placebo and continued treatment with metformin (with or without basal insulin) during the open-label period.	Liraglutide 1.8 mg n=9 Participants After the run-in period, subjects were randomized to receive liraglutide subcutaneous injections once daily (in combination with metformin with or without basal insulin, on a background of diet and exercise) for 52 weeks (26 weeks double blind treatment period followed by a 26-week open-label extension period). The liraglutide dosing was started at 0.6 mg/day during the first week and escalated in weekly increments of 0.6 mg over the following 2-3 weeks. Dose escalation was based on tolerability, as judged by the investigator and on the average of three fasting plasma glucose (FPG) measurements performed by the subject at home on the 3 consecutive days before the dose escalation visit being \>6.1 mmol/L (110 mg/dL). Subjects were treated with doses of 0.6, 1.2 or 1.8 after dose escalation. Subjects treated with liraglutide for more than 3 months were asked to return for follow-up visits one and two years after the end of the open label period (after trial drug cessation at week 52).
Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156	—	1.778 Years Standard Deviation 1.277

Adverse Events

Liraglutide 1.8 mg

Serious events: 9 serious events

Other events: 45 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 49 other events

Deaths: 0 deaths

Liraglutide 1.8 mg: Follow-up 1

Serious events: 7 serious events

Other events: 7 other events

Deaths: 0 deaths

Liraglutide 1.8 mg: Follow-up 2

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER