To Compare the Effect of Liraglutide When Given Together... | NCT00318461

NCT00318461

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

Arm Groups

Label	Type	Description	Intervention Names
Lira 0.6 + Met	Experimental	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day	Drug: liraglutide Drug: metformin Drug: placebo
Lira 1.2 + Met	Experimental	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day	Drug: metformin Drug: placebo Drug: liraglutide
Lira 1.8 + Met	Experimental	Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day	Drug: metformin Drug: placebo Drug: liraglutide
Met Mono	Active Comparator	Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo	Drug: metformin Drug: placebo
Met + Glim	Active Comparator	Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo	Drug: metformin Drug: glimepiride Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	0.6 mg for s.c. (under the skin) injection.	Lira 0.6 + Met

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Glycosylated A1c (HbA1c) at Week 26	Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)	week 0, week 26
Change in Glycosylated A1c (HbA1c) at Week 104	Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)	week 0, week 104

Secondary Outcomes

Measure	Description	Time Frame
Change in Body Weight at Week 26	Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)	week 0, week 26
Change in Body Weight at Week 104	Change in body weight from baseline (week 0) to 104 weeks (end of treatment)

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		Ciudad Autonoma de Bs As		C1405CWB	Argentina
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18931095	Result	Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. doi: 10.2337/dc08-1355. Epub 2008 Oct 17.
19245711

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	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
FG001	Lira 1.2 + Met

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

FG000242 subjectsRandomised

FG001241 subjectsRandomised

FG002242 subjectsRandomised

FG003122 subjectsRandomised

FG004244 subjectsRandomised

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
BG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
BG002	Lira 1.8 + Met	Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
BG003	Met Mono	Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
BG004	Met + Glim	Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
BG005	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
	BG00056.0± 10.5 BG00157.2± 9.2 BG00256.8± 9.4 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00091 BG001111 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Previous anti-diabetic treatment

Number

participants

Title

Denominators

Categories

Mono-therapy

Title	Measurements
	BG00081 BG00190 BG002

BMI

Body Mass Index

Mean

Standard Deviation

kg/m2

Title

Denominators

Categories

Title	Measurements
	BG00030.5± 4.8 BG00131.1± 4.8 BG002

Duration of diabetes

Number of years since diagnosis of diabetes

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0007.0± 4.8 BG0016.8± 4.9 BG002

HbA1c

Glycosylated Haemoglobin at screening

Mean

Standard Deviation

percentage of total haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.4± 0.9 BG0018.3± 0.9 BG002

Height

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG0001.69± 0.10 BG0011.68± 0.11 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 A1c (HbA1c) at Week 26

Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)

Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Posted

Least Squares Mean

Standard Error

Percentage point of total HbA1c

week 0, week 26

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG002	Lira 1.8 + Met	Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG003	Met Mono	Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG004	Met + Glim	Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)

Units	Counts
Participants	OG000239 OG001232 OG002236 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.69± 0.07 OG001-0.97± 0.07 OG002-1.00± 0.07 OG003

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
OG002 OG003	Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.	ANCOVA		<0.0001		Estimated treatment difference, LS Mean	-1.09				95	-1.30	-0.88					Non-Inferiority or Equivalence	Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.

Secondary

Change in Body Weight at Week 26

Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)

Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Posted

Least Squares Mean

Standard Error

week 0, week 26

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG002	Lira 1.8 + Met	Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG003

Secondary

Change in Body Weight at Week 104

Change in body weight from baseline (week 0) to 104 weeks (end of treatment)

Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Posted

Least Squares Mean

Standard Error

week 0, week 104

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG002	Lira 1.8 + Met	Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG003

Secondary

Change in Fasting Plasma Glucose (FPG) at Week 26

Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)

Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Posted

Least Squares Mean

Standard Error

mmol/L

week 0, week 26

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG002	Lira 1.8 + Met	Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)

Secondary

Change in Fasting Plasma Glucose (FPG) at Week 104

Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment)

Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Posted

Least Squares Mean

Standard Error

mmol/L

week 0, week 104

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG002	Lira 1.8 + Met	Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)

Secondary

Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26

Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.

Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.

Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Posted

Least Squares Mean

Standard Error

mmol/l

week 0, week 26

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)

Primary

Change in Glycosylated A1c (HbA1c) at Week 104

Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)

Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Posted

Least Squares Mean

Standard Error

percentage of total haemoglobin

week 0, week 104

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG002	Lira 1.8 + Met	Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)

Secondary

Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104

Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.

Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.

Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Posted

Least Squares Mean

Standard Error

mmol/L

week 0, week 104

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)

Secondary

Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26

Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.

Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Posted

Least Squares Mean

Standard Error

mmol/L

week 0, week 26

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG002	Lira 1.8 + Met

Secondary

Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104

Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.

Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Posted

Least Squares Mean

Standard Error

mmol/L

week 0, week 104

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG002	Lira 1.8 + Met

Secondary

Change in Beta-cell Function at Week 26

Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).

Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Posted

Least Squares Mean

Standard Error

percentage point (%point)

week 0, week 26

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG002	Lira 1.8 + Met

Secondary

Change in Beta-cell Function at Week 104

Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).

Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.

Posted

Least Squares Mean

Standard Error

percentage point (%point)

week 0, week 104

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG002	Lira 1.8 + Met

Secondary

Hypoglycaemic Episodes at Week 26

Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Safety analysis set is all randomised subjects who were exposed to at least one dose of study product.

Posted

Number

episodes

weeks 0-26

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG002	Lira 1.8 + Met	Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)

Secondary

Hypoglycaemic Episodes at Week 104

Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Safety analysis set is all randomised subjects who were exposed to at least one dose of study product.

Posted

Number

episodes

weeks 0-104

ID	Title	Description
OG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
OG002	Lira 1.8 + Met	Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lira 0.6 + Met	Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)	36	242	132	242
EG001	Lira 1.2 + Met	Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)	25	240	144	240
EG002	Lira 1.8 + Met	Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)	16	242	158	242
EG003	Met Mono	Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)	9	121	44	121
EG004	Met + Glim	Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)	24	242	128	242

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected242 at risk EG0012 events2 affected240 at risk EG0021 events1 affected242 at risk EG0030 events0 affected121 at risk EG0040 events0 affected242 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0022 events2 affected242 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Congestive cardiomyopathy	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Right ventricular failure	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0021 events1 affected242 at risk EG003
Tachycardia paroxysmal	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Brain contusion	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Femur fracture	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Sympathetic nerve injury	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0021 events1 affected242 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0022 events2 affected242 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0021 events1 affected242 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Femoral hernia, obstructive	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0021 events1 affected242 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0012 events2 affected240 at risk EG0020 events0 affected242 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0021 events1 affected242 at risk EG003
Muscle disorder	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0022 events2 affected242 at risk EG003
Abscess sweat gland	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Erysipelas	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Tuberculosis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Wound sepsis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Lung carcinoma cell type unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0021 events1 affected242 at risk EG003
Malignant lymphoma unclassifiable high grade	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Cerebral hypoperfusion	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Diabetic neuropathy	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0021 events1 affected242 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Goitre	Endocrine disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0011 events1 affected240 at risk EG0022 events2 affected242 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Calculus ureteric	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Snoring	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Hernia	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Chest pain	General disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Pyrexia	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Cataract	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Uveitis	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0021 events1 affected242 at risk EG003
Blood calcitonin increased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Electrocardiogram abnormal	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Heart rate increased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Penile ulceration	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Arterial stenosis limb	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0021 events1 affected242 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0021 events1 affected242 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Vestibular disorder	Ear and labyrinth disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected242 at risk EG0010 events0 affected240 at risk EG0020 events0 affected242 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected242 at risk EG0011 events1 affected240 at risk EG0020 events0 affected242 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00069 events43 affected242 at risk EG00170 events36 affected240 at risk EG00243 events36 affected242 at risk EG00321 events12 affected121 at risk EG00480 events49 affected242 at risk
Influenza	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00017 events14 affected242 at risk EG00118 events15 affected240 at risk EG00227 events17 affected242 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00016 events11 affected242 at risk EG00119 events14 affected240 at risk EG00219 events15 affected242 at risk EG003
Bronchitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00010 events10 affected242 at risk EG00116 events13 affected240 at risk EG00213 events12 affected242 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00033 events30 affected242 at risk EG00150 events42 affected240 at risk EG00270 events52 affected242 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00040 events31 affected242 at risk EG00143 events27 affected240 at risk EG00250 events40 affected242 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00021 events19 affected242 at risk EG00122 events18 affected240 at risk EG00226 events24 affected242 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00013 events12 affected242 at risk EG0016 events6 affected240 at risk EG00227 events22 affected242 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00011 events10 affected242 at risk EG00111 events8 affected240 at risk EG00213 events13 affected242 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected242 at risk EG00114 events13 affected240 at risk EG0028 events7 affected242 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00021 events16 affected242 at risk EG00117 events15 affected240 at risk EG00220 events17 affected242 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00015 events14 affected242 at risk EG0015 events5 affected240 at risk EG00212 events9 affected242 at risk EG003
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG00041 events26 affected242 at risk EG00140 events34 affected240 at risk EG00251 events35 affected242 at risk EG003
Anorexia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected242 at risk EG00110 events10 affected240 at risk EG00217 events15 affected242 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected242 at risk EG00115 events14 affected240 at risk EG00210 events10 affected242 at risk EG003
Hypertension	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG00011 events11 affected242 at risk EG00115 events13 affected240 at risk EG00211 events11 affected242 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0009 events8 affected242 at risk EG0016 events6 affected240 at risk EG0023 events2 affected242 at risk EG003

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

ID	Term
D000069450	Liraglutide
D008687	Metformin
C057619	glimepiride

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
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

EG0041 events1 affected242 at risk

EG0042 events2 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0042 events2 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG00427 events18 affected242 at risk

EG00419 events12 affected242 at risk

EG00420 events15 affected242 at risk

EG00414 events10 affected242 at risk

EG00420 events14 affected242 at risk

EG0042 events1 affected242 at risk

EG00411 events7 affected242 at risk

EG0046 events4 affected242 at risk

EG0043 events3 affected242 at risk

EG00423 events21 affected242 at risk

EG00422 events19 affected242 at risk

EG00455 events32 affected242 at risk

EG0041 events1 affected242 at risk

EG0040 events0 affected242 at risk

EG00412 events12 affected242 at risk

EG00416 events13 affected242 at risk

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