The Effect of Liraglutide Versus Placebo When Added to Ba... | NCT01617434

NCT01617434

ID	Type	Description	Link
2011-002696-41	EudraCT Number
U1111-1121-9874	Other Identifier	WHO

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions 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
Liraglutide	Experimental		Drug: liraglutide
Placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	Maximum 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26	The estimated mean change from baseline in HbA1c after 26 weeks of treatment.	Week 0 to Week 26

Secondary Outcomes

Measure	Description	Time Frame
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26	The estimated mean change from baseline in FPG after 26 weeks of treatment.	Week 0 to Week 26
Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26

Eligibility Module

Contacts/Locations 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		Phoenix	Arizona	85020	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26179619	Result	Ahmann A, Rodbard HW, Rosenstock J, Lahtela JT, de Loredo L, Tornoe K, Boopalan A, Nauck MA; NN2211-3917 Study Group. Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial. Diabetes Obes Metab. 2015 Nov;17(11):1056-64. doi: 10.1111/dom.12539. Epub 2015 Sep 10.
26582052

Label	URL
Clinical Trials at Novo Nordisk	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
BG001	Placebo	Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
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
	BG00059.3± 9.2 BG00157.5± 11.1 BG00258.4± 10.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000105 BG00189 BG002

Body Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00090.23± 19.98 BG00191.85± 21.33 BG002

Fasting Plasma Glucose (FPG)

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0008.32± 2.89 BG0018.21± 2.90 BG002

Glycosylated Haemoglobin (HbA1c)

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.22± 0.81 BG0018.28± 0.90 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 26

The estimated mean change from baseline in HbA1c after 26 weeks of treatment.

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 215 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0 to Week 26

ID	Title	Description
OG000	Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
OG001	Placebo	Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

Units	Counts
Participants	OG000215 OG001217

Title

Denominators

Categories

Title	Measurements
	OG000-1.30± 1.015 OG001-0.11± 1.088

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	The null hypothesis of no difference between the two treatment arms with regard to changes from baseline in HbA1c (%) after 26 weeks of randomised treatment was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline HbA1c as a covariate, all nested within visit.	Mixed Models Analysis		<0.0001		Mean Difference (Final Values)	-1.19				95	-1.39	-0.99					Superiority or Other

Secondary

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

The estimated mean change from baseline in FPG after 26 weeks of treatment.

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 213 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.

Posted

Mean

Standard Deviation

mmol/L

Week 0 to Week 26

ID	Title	Description
OG000	Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
OG001	Placebo	Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

Secondary

Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26

The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment.

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 191 subjects in the liraglutide arm and 196 subjects in the placebo arm contributed to the statistical analysis.

Posted

Mean

Standard Deviation

mmol/L

Week 0 to Week 26

ID	Title	Description
OG000	Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
OG001	Placebo

Secondary

Change in Body Weight From Baseline to Week 26

The estimated mean change in body weight after 26 weeks of treatment.

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 215 subjects in the liraglutide arm and 216 subjects in the placebo arm contributed to the statistical analysis.

Posted

Mean

Standard Deviation

Week 0 to Week 26

ID	Title	Description
OG000	Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
OG001	Placebo	Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

Secondary

Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)

Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 211 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.

Posted

Number

percentage of subjects

At Week 26

ID	Title	Description
OG000	Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
OG001	Placebo	Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

Secondary

Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)

Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment.

Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product and who provided at least one post-baseline efficacy value. 211 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.

Posted

Number

percentage of subjects

At Week 26

ID	Title	Description
OG000	Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
OG001	Placebo	Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

Secondary

Number of Adverse Events (AEs) During The Randomised Treatment Period

An AE was defined as treatment emergent if the onset date (or increase in severity) 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. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events.

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

Posted

Number

Events/1000 years of patient exposure

Week 0 to Week 26 + 7 days follow up

ID	Title	Description
OG000	Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
OG001	Placebo	Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

Secondary

Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period

A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <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

Events/100 years of patient exposure

Week 0 to Week 26 + 7 days follow up

ID	Title	Description
OG000	Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
OG001	Placebo	Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

Secondary

Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period

Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.

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 26 + 7 days follow up

ID	Title	Description
OG000	Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
OG001	Placebo	Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

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	Liraglutide	Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.			11	225	103	225
EG001	Placebo	Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.			7	225	46	225

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Coronary artery disease	Cardiac disorders	MedDRA version 16.0	Systematic Assessment	EG0000 events0 affected225 at risk EG0012 events2 affected225 at risk
Ileus	Gastrointestinal disorders	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Arthritis bacterial	Infections and infestations	MedDRA version 16.0	Systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected225 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Ear infection	Infections and infestations	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Gastroenteritis	Infections and infestations	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Genital herpes	Infections and infestations	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Osteomyelitis	Infections and infestations	MedDRA version 16.0	Systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected225 at risk
Pneumonia	Infections and infestations	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Pyelonephritis	Infections and infestations	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Fall	Injury, poisoning and procedural complications	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA version 16.0	Systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected225 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA version 16.0	Systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected225 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA version 16.0	Systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected225 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Wound	Injury, poisoning and procedural complications	MedDRA version 16.0	Systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected225 at risk
Electrocardiogram change	Investigations	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 16.0	Systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected225 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA version 16.0	Systematic Assessment	EG0000 events0 affected225 at risk EG0011 events1 affected225 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA version 16.0	Systematic Assessment	EG0001 events1 affected225 at risk EG0010 events0 affected225 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA version 16.0	Systematic Assessment	EG00029 events24 affected225 at risk EG00114 events11 affected225 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA version 16.0	Systematic Assessment	EG00020 events16 affected225 at risk EG0012 events2 affected225 at risk
Nausea	Gastrointestinal disorders	MedDRA version 16.0	Systematic Assessment	EG00062 events50 affected225 at risk EG0018 events7 affected225 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 16.0	Systematic Assessment	EG00028 events20 affected225 at risk EG0013 events2 affected225 at risk
Influenza	Infections and infestations	MedDRA version 16.0	Systematic Assessment	EG00011 events8 affected225 at risk EG00121 events16 affected225 at risk
Nasopharyngitis	Infections and infestations	MedDRA version 16.0	Systematic Assessment	EG00019 events13 affected225 at risk EG00116 events14 affected225 at risk
Lipase increased	Investigations	MedDRA version 16.0	Systematic Assessment	EG00016 events16 affected225 at risk EG0015 events5 affected225 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 16.0	Systematic Assessment	EG00022 events22 affected225 at risk EG0015 events5 affected225 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 16.0	Systematic Assessment	EG00013 events12 affected225 at risk EG00113 events12 affected225 at risk
Headache	Nervous system disorders	MedDRA version 16.0	Systematic Assessment	EG0009 events8 affected225 at risk EG00120 events16 affected225 at risk

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

ID	Term
D000069450	Liraglutide

Ancestor Terms

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

Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.

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