Trial Outcomes & Findings for The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus (NCT NCT00700817)

Results Overview

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

665 participants

Primary outcome timeframe

Week 0, Week 26

Results posted on

2017-03-08

Participant Flow

A total of 158 centres in 13 countries participated: Canada (11), Croatia (3), Germany (12), Ireland (5), Italy (8), Netherlands (8), Romania (4), Serbia (3), Slovakia (6), Slovenia (3), Spain (9), United Kingdom (20) and United States (66). Of the 158 sites approved by an Independent Ethics Committee, 151 actively screened and enrolled subjects.

Between screening and randomisation, eligible subjects were to continue their usual pre-study metformin dose and dosing frequency.

Participant milestones

Participant milestones
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Week 0-26 (Main Period) STARTED	225	221	219	0	0
Week 0-26 (Main Period) Exposed	221	218	219	0	0
Week 0-26 (Main Period) COMPLETED	169	191	194	0	0
Week 0-26 (Main Period) NOT COMPLETED	56	30	25	0	0
Week 26-52 (Extension Period 1) STARTED	155	176	166	0	0
Week 26-52 (Extension Period 1) COMPLETED	135	150	151	0	0
Week 26-52 (Extension Period 1) NOT COMPLETED	20	26	15	0	0
Week 52-78 (Extension Period 2) STARTED	134	150	0	67	68
Week 52-78 (Extension Period 2) COMPLETED	124	135	0	59	63
Week 52-78 (Extension Period 2) NOT COMPLETED	10	15	0	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.
Week 0-26 (Main Period) Adverse Event	14	15	4	0	0
Week 0-26 (Main Period) Lack of Efficacy	4	0	4	0	0
Week 0-26 (Main Period) Protocol Violation	14	4	4	0	0
Week 0-26 (Main Period) Withdrawal criteria	10	7	5	0	0
Week 0-26 (Main Period) Unclassified	14	4	8	0	0
Week 26-52 (Extension Period 1) Adverse Event	5	10	3	0	0
Week 26-52 (Extension Period 1) Protocol Violation	3	2	2	0	0
Week 26-52 (Extension Period 1) Lack of Efficacy	2	3	7	0	0
Week 26-52 (Extension Period 1) Withdrawal criteria	6	8	2	0	0
Week 26-52 (Extension Period 1) Unclassified	4	3	1	0	0
Week 52-78 (Extension Period 2) Adverse Event	0	3	0	6	0
Week 52-78 (Extension Period 2) Protocol Violation	1	2	0	1	1
Week 52-78 (Extension Period 2) Lack of Efficacy	3	3	0	0	0
Week 52-78 (Extension Period 2) Withdrawal criteria	4	3	0	1	3
Week 52-78 (Extension Period 2) Unclassified	2	4	0	0	1

Baseline Characteristics

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=225 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=221 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=219 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Total n=665 Participants Total of all reporting groups
Age, Continuous	55.9 years STANDARD_DEVIATION 9.6 • n=5 Participants	55.0 years STANDARD_DEVIATION 9.1 • n=7 Participants	55.0 years STANDARD_DEVIATION 9.0 • n=5 Participants	—	—	55.3 years STANDARD_DEVIATION 9.2 • n=10 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	105 Participants n=7 Participants	99 Participants n=5 Participants	—	—	313 Participants n=10 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	116 Participants n=7 Participants	120 Participants n=5 Participants	—	—	352 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	39 Participants n=5 Participants	34 Participants n=7 Participants	35 Participants n=5 Participants	—	—	108 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	186 Participants n=5 Participants	187 Participants n=7 Participants	184 Participants n=5 Participants	—	—	557 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	3 Participants n=10 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	—	—	11 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	—	—	2 Participants n=10 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	—	—	48 Participants n=10 Participants
Race (NIH/OMB) White	184 Participants n=5 Participants	193 Participants n=7 Participants	199 Participants n=5 Participants	—	—	576 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	—	—	25 Participants n=10 Participants
Body Mass Index (BMI) at Screening	32.6 kg/m^2 STANDARD_DEVIATION 5.2 • n=5 Participants	33.1 kg/m^2 STANDARD_DEVIATION 5.1 • n=7 Participants	32.6 kg/m^2 STANDARD_DEVIATION 5.4 • n=5 Participants	—	—	32.8 kg/m^2 STANDARD_DEVIATION 5.2 • n=10 Participants
Duration of Diabetes	6.0 years STANDARD_DEVIATION 4.5 • n=5 Participants	6.4 years STANDARD_DEVIATION 5.4 • n=7 Participants	6.3 years STANDARD_DEVIATION 5.4 • n=5 Participants	—	—	6.2 years STANDARD_DEVIATION 5.1 • n=10 Participants
Fasting Plasma Glucose (FPG) at Randomisation	10.1 mmol/L STANDARD_DEVIATION 2.4 • n=5 Participants	9.9 mmol/L STANDARD_DEVIATION 2.4 • n=7 Participants	10.0 mmol/L STANDARD_DEVIATION 2.0 • n=5 Participants	—	—	10.0 mmol/L STANDARD_DEVIATION 2.3 • n=10 Participants
Glycosylated Haemoglobin A1c (HbA1c) at Randomisation	8.4 Percentage point of total HbA1c STANDARD_DEVIATION 0.8 • n=5 Participants	8.4 Percentage point of total HbA1c STANDARD_DEVIATION 0.7 • n=7 Participants	8.5 Percentage point of total HbA1c STANDARD_DEVIATION 0.7 • n=5 Participants	—	—	8.4 Percentage point of total HbA1c STANDARD_DEVIATION 0.8 • n=10 Participants

PRIMARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=211 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=210 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26	-1.24 Percentage point of total HbA1c Standard Error 0.07	—	-1.5 Percentage point of total HbA1c Standard Error 0.06	-0.9 Percentage point of total HbA1c Standard Error 0.07	—

PRIMARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=211 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=210 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52	-1.29 Percentage point of total HbA1c Standard Error 0.07	—	-1.51 Percentage point of total HbA1c Standard Error 0.07	-0.88 Percentage point of total HbA1c Standard Error 0.07	—

PRIMARY outcome

Timeframe: Week 0, Week 78

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=211 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78	-0.94 Percentage point of total HbA1c Standard Error 0.08	—	-1.28 Percentage point of total HbA1c Standard Error 0.07	—	—

PRIMARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=68 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78	—	-0.45 Percentage point of total HbA1c Standard Deviation 0.9	—	—	-0.24 Percentage point of total HbA1c Standard Deviation 0.7

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 26

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=221 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=218 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=219 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26	43 percentage of subjects	—	55 percentage of subjects	22 percentage of subjects	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 52

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=211 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=210 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52	50 percentage of subjects	—	63 percentage of subjects	27 percentage of subjects	—

SECONDARY outcome

Timeframe: Week 0, Week 78

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the FAS.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=211 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78	35 percentage of subjects	—	51 percentage of subjects	—	—

SECONDARY outcome

Timeframe: Week 0, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the extension 2 FAS.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=68 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78	—	50 percentage of subjects	—	—	49 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 26

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=221 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=218 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=219 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26	23 percentage of subjects	—	36 percentage of subjects	12 percentage of subjects	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 52

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=211 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=210 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52	24 percentage of subjects	—	40 percentage of subjects	17 percentage of subjects	—

SECONDARY outcome

Timeframe: Week 0, Week 78

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the FAS.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=211 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78	12 percentage of subjects	—	27 percentage of subjects	—	—

SECONDARY outcome

Timeframe: Week 0, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the extension 2 FAS.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=68 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78	—	25 percentage of subjects	—	—	29 percentage of subjects

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in body weight at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=215 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=215 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Body Weight at Week 26	-2.86 kg Standard Error 0.27	—	-3.38 kg Standard Error 0.27	-0.96 kg Standard Error 0.27	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in body weight at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=215 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=215 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Body Weight at Week 52	-2.78 kg Standard Error 0.31	—	-3.68 kg Standard Error 0.31	-1.16 kg Standard Error 0.31	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in body weight from Week 52 to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=68 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Body Weight From Week 52 to Week 78	—	-2.48 kg Standard Deviation 3.6	—	—	-1.64 kg Standard Deviation 3

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=210 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=212 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=210 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	-1.87 mmol/L Standard Error 0.15	—	-2.14 mmol/L Standard Error 0.15	-0.83 mmol/L Standard Error 0.15	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=210 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=212 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=209 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52	-1.71 mmol/L Standard Error 0.17	—	-2.04 mmol/L Standard Error 0.17	-0.59 mmol/L Standard Error 0.17	—

SECONDARY outcome

Timeframe: Week 0, Week 78

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=210 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=212 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78	-1.30 mmol/L Standard Error 0.18	—	-1.65 mmol/L Standard Error 0.18	—	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=65 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78	—	-1.42 mmol/L Standard Deviation 2.1	—	—	-0.84 mmol/L Standard Deviation 1.8

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=196 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=208 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=201 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Beta-cell Function at Week 26	27.23 percentage point Standard Error 3.82	—	28.70 percentage point Standard Error 3.75	4.18 percentage point Standard Error 3.79	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=196 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=208 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=200 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Beta-cell Function at Week 52	22.58 percentage point Standard Error 3.31	—	25.76 percentage point Standard Error 3.25	3.98 percentage point Standard Error 3.30	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=64 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=64 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Beta-cell Function From Week 52 to Week 78	—	23.09 percentage point Standard Deviation 43.7	—	—	13.31 percentage point Standard Deviation 29.4

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=194 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=202 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=201 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Total Cholesterol at Week 26	-0.03 mmol/L Standard Error 0.06	—	-0.17 mmol/L Standard Error 0.05	-0.02 mmol/L Standard Error 0.05	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=195 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=203 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=200 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Total Cholesterol at Week 52	-0.01 mmol/L Standard Error 0.06	—	-0.09 mmol/L Standard Error 0.06	0.03 mmol/L Standard Error 0.06	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in total cholesterol from Week 52 to Week 78

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=65 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Total Cholesterol From Week 52 to Week 78	—	-0.24 mmol/L Standard Deviation 0.7	—	—	-0.16 mmol/L Standard Deviation 0.8

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=194 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=202 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=200 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26	0.08 mmol/L Standard Error 0.05	—	0.05 mmol/L Standard Error 0.05	0.13 mmol/L Standard Error 0.05	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=195 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=203 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=199 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52	0.09 mmol/L Standard Error 0.05	—	0.09 mmol/L Standard Error 0.05	0.17 mmol/L Standard Error 0.05	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=65 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78	—	-0.25 mmol/L Standard Deviation 0.6	—	—	-0.22 mmol/L Standard Deviation 0.7

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=194 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=201 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=201 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26	0.00 mmol/L Standard Error 0.01	—	0.00 mmol/L Standard Error 0.01	0.00 mmol/L Standard Error 0.01	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=195 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=202 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=200 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52	0.01 mmol/L Standard Error 0.01	—	0.02 mmol/L Standard Error 0.01	0.01 mmol/L Standard Error 0.01	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=65 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78	—	-0.01 mmol/L Standard Deviation 0.2	—	—	0.02 mmol/L Standard Deviation 0.1

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=194 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=201 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=199 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26	-0.11 mmol/L Standard Error 0.03	—	-0.20 mmol/L Standard Error 0.03	-0.15 mmol/L Standard Error 0.03	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=195 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=202 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=198 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52	-0.11 mmol/L Standard Error 0.04	—	-0.19 mmol/L Standard Error 0.04	-0.15 mmol/L Standard Error 0.04	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=65 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78	—	0.02 mmol/L Standard Deviation 0.3	—	—	0.03 mmol/L Standard Deviation 0.3

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=191 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=199 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=198 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Triglycerides (TG) at Week 26	-0.19 mmol/L Standard Error 0.10	—	-0.43 mmol/L Standard Error 0.09	-0.40 mmol/L Standard Error 0.09	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=194 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=200 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=197 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Triglycerides (TG) at Week 52	-0.10 mmol/L Standard Error 0.10	—	-0.32 mmol/L Standard Error 0.10	-0.23 mmol/L Standard Error 0.10	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in triglycerides (TG) from Week 52 to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=66 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=64 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Triglycerides (TG) From Week 52 to Week 78	—	-0.26 mmol/L Standard Deviation 0.8	—	—	-0.20 mmol/L Standard Deviation 0.8

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=147 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=149 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=158 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26	-0.03 mmol/L Standard Error 0.02	—	-0.07 mmol/L Standard Error 0.02	-0.05 mmol/L Standard Error 0.02	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=170 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=177 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=176 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52	-0.07 mmol/L Standard Error 0.02	—	-0.10 mmol/L Standard Error 0.02	-0.06 mmol/L Standard Error 0.02	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in free fatty acids (FFA) from Week 52 to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=65 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=60 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78	—	-0.01 mmol/L Standard Deviation 0.3	—	—	0.02 mmol/L Standard Deviation 0.3

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=164 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=175 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=182 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Apolipoprotein B at Week 26	-0.06 g/L Standard Error 0.01	—	-0.07 g/L Standard Error 0.01	-0.05 g/L Standard Error 0.01	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=184 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=192 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=195 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Apolipoprotein B at Week 52	-0.03 g/L Standard Error 0.01	—	-0.03 g/L Standard Error 0.01	-0.03 g/L Standard Error 0.01	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=68 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=66 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Apolipoprotein B From Week 52 to Week 78	—	0.17 mmol/L Standard Deviation 0.4	—	—	0.23 mmol/L Standard Deviation 0.4

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=205 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=209 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=205 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26	-1.02 mg/L Standard Error 0.31	—	-0.99 mg/L Standard Error 0.31	-0.66 mg/L Standard Error 0.31	—

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=188 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=198 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=182 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.	-833 U/L Standard Error 945.1	—	-561 U/L Standard Error 941.1	586 U/L Standard Error 952	—

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=204 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=210 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=206 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.	-1.70 pg/mL Standard Error 2.49	—	1.71 pg/mL Standard Error 2.47	0.91 pg/mL Standard Error 2.49	—

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=204 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=209 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=205 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.	5.19 pmol/L Standard Error 2.07	—	3.74 pmol/L Standard Error 2.06	3.71 pmol/L Standard Error 2.07	—

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=202 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=210 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=207 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Adiponectin at Week 26.	1.69 mcg/mL Standard Error 0.19	—	1.51 mcg/mL Standard Error 0.19	1.35 mcg/mL Standard Error 0.19	—

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=195 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=204 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=196 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.	-0.55 pg/mL Standard Error 0.25	—	-0.74 pg/mL Standard Error 0.25	-0.53 pg/mL Standard Error 0.25	—

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=189 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=193 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=183 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.	-1.73 percentage point Standard Error 2.77	—	-4.34 percentage point Standard Error 2.76	-1.8 percentage point Standard Error 2.82	—

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=210 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=208 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=207 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Waist to Hip Ratio at Week 26.	-0.01 cm/cm Standard Error 0.00	—	-0.01 cm/cm Standard Error 0.00	-0.00 cm/cm Standard Error 0.00	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=210 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=208 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=207 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Waist to Hip Ratio at Week 52	-0.00 cm/cm Standard Error 0.00	—	-0.01 cm/cm Standard Error 0.00	-0.00 cm/cm Standard Error 0.00	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=66 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Waist to Hip Ratio From Week 52 to Week 78	—	-0.00 cm/cm Standard Deviation 0	—	—	-0.01 cm/cm Standard Deviation 0

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=210 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=208 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=208 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Waist Circumference at Week 26.	-2.69 cm Standard Error 0.35	—	-2.63 cm Standard Error 0.36	-1.12 cm Standard Error 0.36	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=210 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=208 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=208 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Waist Circumference at Week 52	-2.36 participants Standard Error 0.38	—	-3.02 participants Standard Error 0.38	-1.23 participants Standard Error 0.38	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in Waist Circumference from Week 52 to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=68 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=66 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Waist Circumference From Week 52 to Week 78	—	-2.05 kg Standard Deviation 4.1	—	—	-1.33 kg Standard Deviation 3.5

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=213 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=213 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26	-0.55 mmHg Standard Error 0.89	—	-0.72 mmHg Standard Error 0.89	-0.94 mmHg Standard Error 0.89	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=213 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=213 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52	-0.37 mmHg Standard Error 0.93	—	-2.55 mmHg Standard Error 0.93	-1.03 mmHg Standard Error 0.93	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=68 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78	—	0.35 mmHg Standard Deviation 12.4	—	—	-2.12 mmHg Standard Deviation 14.6

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=213 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=213 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26	-0.71 mmHg Standard Error 0.60	—	0.07 mmHg Standard Error 0.59	-1.78 mmHg Standard Error 0.60	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=213 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=213 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52	-0.53 mmHg Standard Error 0.57	—	-0.87 mmHg Standard Error 0.57	-1.47 mmHg Standard Error 0.57	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=68 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78	—	0.03 mmHg Standard Deviation 8.9	—	—	-0.60 mmHg Standard Deviation 10.0

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in pulse at Week 26.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=212 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=211 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Pulse at Week 26	2.32 beats/minute Standard Error 0.59	—	3.94 beats/minute Standard Error 0.58	-0.64 beats/minute Standard Error 0.59	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.

Calculated as an estimate of the mean change from baseline in pulse at Week 52.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=212 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=214 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=211 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Pulse at Week 52	1.72 mmHg Standard Error 0.60	—	3.09 mmHg Standard Error 0.60	0.09 mmHg Standard Error 0.60	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Mean change in pulse from Week 52 to Week 78.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=68 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Pulse From Week 52 to Week 78	—	2.19 beats/minute Standard Deviation 7.7	—	—	0.90 beats/minute Standard Deviation 8.4

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia

The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=164 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=171 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=170 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26	3.51 scores on a scale Standard Error 0.49	—	4.35 scores on a scale Standard Error 0.48	2.96 scores on a scale Standard Error 0.48	—

SECONDARY outcome

Timeframe: Week 0, Week 52

Population: Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia

The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=163 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=165 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=169 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52	3.32 scores on a scale Standard Error 0.49	—	4.31 scores on a scale Standard Error 0.48	2.96 scores on a scale Standard Error 0.48	—

SECONDARY outcome

Timeframe: Week 52, Week 78

Population: Extension 2 Patient Reported Outcome Analysis Set consisted of all subjects in the Extension 2 FAS, except subjects from countries Serbia, Slovakia and Slovenia

The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=48 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=54 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78	—	0.98 scores on a scale Standard Deviation 6.1	—	—	1.48 scores on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: Weeks 0-26

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

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=221 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=218 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=219 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Hypoglyceamic Episodes, Weeks 0-26 Unclassified	0 episodes	—	1 episodes	0 episodes	—
Hypoglyceamic Episodes, Weeks 0-26 Major	1 episodes	—	0 episodes	0 episodes	—
Hypoglyceamic Episodes, Weeks 0-26 Minor	17 episodes	—	37 episodes	11 episodes	—
Hypoglyceamic Episodes, Weeks 0-26 Symptoms only	12 episodes	—	15 episodes	10 episodes	—

SECONDARY outcome

Timeframe: Weeks 0-26

Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 21 minor hypoglycaemic episodes was excluded from this analysis.

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=221 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=217 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=219 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 Minor	17 episodes	—	16 episodes	11 episodes	—
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 Major	1 episodes	—	0 episodes	0 episodes	—
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 Symptoms only	12 episodes	—	15 episodes	10 episodes	—
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 Unclassified	0 episodes	—	1 episodes	0 episodes	—

SECONDARY outcome

Timeframe: Weeks 0-52

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

Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=221 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=218 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=219 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Hypoglyceamic Episodes, Weeks 0-52 Major	1 episodes	—	0 episodes	0 episodes	—
Hypoglyceamic Episodes, Weeks 0-52 Minor	24 episodes	—	51 episodes	25 episodes	—
Hypoglyceamic Episodes, Weeks 0-52 Symptoms only	14 episodes	—	29 episodes	12 episodes	—
Hypoglyceamic Episodes, Weeks 0-52 Unclassified	0 episodes	—	1 episodes	0 episodes	—

SECONDARY outcome

Timeframe: Weeks 0-52

Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.

Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=221 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=218 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=219 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 Major	1 episodes	—	0 episodes	0 episodes	—
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 Minor	24 episodes	—	28 episodes	25 episodes	—
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 Symptoms only	14 episodes	—	29 episodes	12 episodes	—
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52 Unclassified	0 episodes	—	1 episodes	0 episodes	—

SECONDARY outcome

Timeframe: Weeks 0-78

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

Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=221 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=218 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=219 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Hypoglyceamic Episodes, Weeks 0-78 Major	2 episodes	—	0 episodes	0 episodes	—
Hypoglyceamic Episodes, Weeks 0-78 Minor	36 episodes	—	56 episodes	34 episodes	—
Hypoglyceamic Episodes, Weeks 0-78 Symptoms only	18 episodes	—	40 episodes	13 episodes	—
Hypoglyceamic Episodes, Weeks 0-78 Unclassified	0 episodes	—	1 episodes	0 episodes	—

SECONDARY outcome

Timeframe: Weeks 0-78

Population: The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.

Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=221 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=218 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=219 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 Major	2 episodes	—	0 episodes	0 episodes	—
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 Minor	36 episodes	—	33 episodes	34 episodes	—
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 Symptoms only	18 episodes	—	40 episodes	13 episodes	—
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78 Unclassified	0 episodes	—	1 episodes	0 episodes	—

SECONDARY outcome

Timeframe: Week 52-78

Population: Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)

Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Outcome measures

Outcome measures
Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=134 Participants Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita -> Lira 1.8 mg n=68 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=150 Participants Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).	Sita -> Sita -> Lira 1.2 mg n=67 Participants Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.
Hypoglycaamic Episodes, Weeks 52-78 Unclassified	0 episodes	0 episodes	0 episodes	—	0 episodes
Hypoglycaamic Episodes, Weeks 52-78 Major	1 episodes	0 episodes	0 episodes	—	0 episodes
Hypoglycaamic Episodes, Weeks 52-78 Minor	12 episodes	6 episodes	5 episodes	—	3 episodes
Hypoglycaamic Episodes, Weeks 52-78 Symptoms only	3 episodes	0 episodes	11 episodes	—	1 episodes

Adverse Events

Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg

Serious events: 12 serious events

Other events: 120 other events

Deaths: 0 deaths

Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg

Serious events: 19 serious events

Other events: 134 other events

Deaths: 0 deaths

Sita -> Sita

Serious events: 17 serious events

Other events: 106 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Public Access to Clinical Trials

Novo Nordisk A/S

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER

Measure	Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg n=221 participants at risk Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg n=218 participants at risk Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).	Sita -> Sita n=219 participants at risk Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).
Gastrointestinal disorders Nausea	21.7% 48/221 • Number of events 60 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	28.0% 61/218 • Number of events 73 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	16.4% 36/219 • Number of events 45 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Gastrointestinal disorders Diarrhoea	9.5% 21/221 • Number of events 30 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	13.3% 29/218 • Number of events 52 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	11.0% 24/219 • Number of events 40 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Gastrointestinal disorders Vomiting	8.1% 18/221 • Number of events 27 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	11.0% 24/218 • Number of events 28 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	6.8% 15/219 • Number of events 21 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Gastrointestinal disorders Dyspepsia	3.6% 8/221 • Number of events 9 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	7.8% 17/218 • Number of events 23 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	5.0% 11/219 • Number of events 17 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Gastrointestinal disorders Constipation	4.5% 10/221 • Number of events 11 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	6.4% 14/218 • Number of events 16 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	4.6% 10/219 • Number of events 11 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Infections and infestations Nasopharyngitis	14.9% 33/221 • Number of events 42 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	16.5% 36/218 • Number of events 52 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	14.6% 32/219 • Number of events 50 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Infections and infestations Influenza	6.3% 14/221 • Number of events 17 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	3.2% 7/218 • Number of events 7 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	4.1% 9/219 • Number of events 13 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Nervous system disorders Headache	10.4% 23/221 • Number of events 36 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	14.2% 31/218 • Number of events 56 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	15.1% 33/219 • Number of events 50 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Metabolism and nutrition disorders Decreased appetite	3.6% 8/221 • Number of events 8 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	5.5% 12/218 • Number of events 12 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	4.1% 9/219 • Number of events 9 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
General disorders Fatigue	4.1% 9/221 • Number of events 9 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	6.0% 13/218 • Number of events 14 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	2.3% 5/219 • Number of events 5 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Infections and infestations Upper respiratory tract infection	7.2% 16/221 • Number of events 27 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	5.0% 11/218 • Number of events 16 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	6.4% 14/219 • Number of events 20 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Investigations Blood calcitonin increased	4.1% 9/221 • Number of events 9 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	5.0% 11/218 • Number of events 14 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	2.7% 6/219 • Number of events 7 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Musculoskeletal and connective tissue disorders Back pain	5.9% 13/221 • Number of events 21 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	6.4% 14/218 • Number of events 16 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	5.9% 13/219 • Number of events 16 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Nervous system disorders Dizziness	4.5% 10/221 • Number of events 10 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	6.4% 14/218 • Number of events 19 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	3.7% 8/219 • Number of events 8 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.
Vascular disorders Hypertension	5.9% 13/221 • Number of events 13 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	6.4% 14/218 • Number of events 14 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.	3.2% 7/219 • Number of events 8 • The adverse events were collected in a timeframe of 78 weeks. The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.