Efficacy and Safety of Liraglutide in Combination With In... | NCT01572740

ID	Type	Description	Link
U1111-1122-4320	Other Identifier	WHO
JapicCTI-121802	Other Identifier	JAPIC

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Lira+Insulin	Experimental		Drug: liraglutide Drug: insulin
Placebo+Insulin	Placebo Comparator		Drug: placebo Drug: insulin

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.	Lira+Insulin

Outcomes Module

Measure	Description	Time Frame
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16	Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.	Week 0, Week 16

Secondary Outcomes

Measure	Description	Time Frame
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36	Estimated mean change from baseline in HbA1c after 36 Weeks of treatment	Week 0, Week 36
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16

Eligibility Module

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Chuo-ku, Tokyo		103 0002	Japan
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27182042	Result	Seino Y, Kaneko S, Fukuda S, Osonoi T, Shiraiwa T, Nishijima K, Bosch-Traberg H, Kaku K. Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36-week, randomized, double-blind, parallel-group trial. J Diabetes Investig. 2016 Jul;7(4):565-73. doi: 10.1111/jdi.12457. Epub 2016 Jan 23.
29277968

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
BG001	Placebo + Insulin	Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00061.3± 11.0 BG00159.8± 11.3 BG00260.5± 11.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00058 BG00155 BG002

Body Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00067.7± 15.2 BG00165.9± 13.0 BG002

Fasting Plasma Glucose (FPG)

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0008.51± 2.42 BG0018.79± 2.51 BG002

Glycosylated Haemoglobin (HbA1c)

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.8± 0.9 BG0018.8± 0.9 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16

Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.

Posted

Mean

Standard Error

percentage of glycosylated haemoglobin

Week 0, Week 16

ID	Title	Description
OG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
OG001	Placebo + Insulin	Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.

Units	Counts
Participants	OG000127 OG001129

Title

Denominators

Categories

Title	Measurements
	OG000-1.73± 0.06 OG001-0.43± 0.06

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<0.0001		Estimated treatment difference, Mean	-1.30				95	-1.47	-1.13					Superiority or Other

Secondary

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36

Estimated mean change from baseline in HbA1c after 36 Weeks of treatment

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.

Posted

Mean

Standard Error

percentage of glycosylated haemoglobin

Week 0, Week 36

ID	Title	Description
OG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
OG001	Placebo + Insulin	Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.

Secondary

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16

Estimated mean change from baseline in FPG after 16 Weeks of treatment.

Posted

Mean

Standard Error

mmol/L

Week 0, Week 16

ID	Title	Description
OG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
OG001	Placebo + Insulin	Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.

Secondary

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36

Estimated mean change from baseline in FPG after 36 Weeks of treatment.

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.

Posted

Mean

Standard Error

mmol/L

Week 0, Week 36

ID	Title	Description
OG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
OG001	Placebo + Insulin	Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.

Secondary

Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16

Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 9 subjects did not contribute to the statistical analysis at Week 16 due to missing data.

Posted

Mean

Standard Error

mmol/L

Week 0, Week 16

ID	Title	Description
OG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
OG001	Placebo + Insulin	Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.

Secondary

Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 8 subjects did not contribute to the statistical analysis at Week 36 due to missing data.

Posted

Mean

Standard Error

mmol/L

Week 0, Week 36

ID	Title	Description
OG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
OG001	Placebo + Insulin	Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.

Secondary

Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16

Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 9 subjects did not contribute to the statistical analysis at Week 16 due to missing data.

Posted

Mean

Standard Error

mmol/L

Week 0, Week 16

ID	Title	Description
OG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
OG001	Placebo + Insulin

Secondary

Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 13 subjects did not contribute to the statistical analysis at Week 36 due to missing data.

Posted

Mean

Standard Error

mmol/L

Week 0, Week 36

ID	Title	Description
OG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
OG001	Placebo + Insulin

Secondary

Change in Body Weight From Baseline to Week 16

Estimated mean change in body weight after 16 Weeks of treatment

Posted

Mean

Standard Error

Week 0, Week 16

ID	Title	Description
OG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
OG001	Placebo + Insulin	Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.

Secondary

Change in Body Weight From Baseline to Week 36

Estimated mean change in body weight after 36 Weeks of treatment

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.

Posted

Mean

Standard Error

Week 0, Week 36

ID	Title	Description
OG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
OG001	Placebo + Insulin	Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.

Secondary

Number of Adverse Events (AEs)

An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.

Safety analysis set includes all subjects who received at least one dose of the trial products.

Posted

Number

Events/100 years of patient exposure

Week 0 to Week 36 (inclusive)

ID	Title	Description
OG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
OG001	Placebo + Insulin	Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.

Secondary

Number of Confirmed Hypoglycaemic Episodes

A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episode was defined as hypoglycaemic episodes categorised to severe and/or minor hypoglycaemic episodes.

Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded PG < 3.1 mmol/L (56 mg/dL). Minor: PG < 3.1 mmol/L (56 mg/dL).

Safety analysis set includes all subjects who received at least one dose of the trial products.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to week 36 (inclusive)

ID	Title	Description
OG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.
OG001	Placebo + Insulin

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lira + Insulin	Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.			6	127	93	127
EG001	Placebo + Insulin	Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.			4	130	69	130

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected127 at risk EG0011 events1 affected130 at risk
Angina pectoris	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected127 at risk EG0010 events0 affected130 at risk
Cataract	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected127 at risk EG0010 events0 affected130 at risk
Macular fibrosis	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected127 at risk EG0010 events0 affected130 at risk
Pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected127 at risk EG0011 events1 affected130 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected127 at risk EG0010 events0 affected130 at risk
Brain stem thrombosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected127 at risk EG0010 events0 affected130 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected127 at risk EG0010 events0 affected130 at risk
Cerebral infarction	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected127 at risk EG0011 events1 affected130 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected127 at risk EG0011 events1 affected130 at risk
Hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected127 at risk EG0010 events0 affected130 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diabetic retinopathy	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0009 events9 affected127 at risk EG00116 events13 affected130 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00016 events15 affected127 at risk EG0012 events2 affected130 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00017 events15 affected127 at risk EG0014 events4 affected130 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0009 events7 affected127 at risk EG0010 events0 affected130 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00016 events14 affected127 at risk EG0019 events7 affected130 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0007 events4 affected127 at risk EG0017 events7 affected130 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00074 events55 affected127 at risk EG00160 events40 affected130 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected127 at risk EG0017 events7 affected130 at risk
Headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00010 events8 affected127 at risk EG0016 events6 affected130 at risk
Hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected127 at risk EG0016 events6 affected130 at risk

Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.

All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted.

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins