Brief Summary

This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

929

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Jan 2008

Geographic Reach

3 countries

50 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

January 1, 2008

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed

29 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

March 12, 2010

Completed

Last Updated

March 8, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

January 15, 2008

Results QC Date

February 23, 2010

Last Update Submit

January 25, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin A1c (HbA1c)
Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).
week 0, week 16

Secondary Outcomes (7)

Change in Body Weight
week 0, week 16
Change in Self-measured Fasting Plasma Glucose
week 0, week 16
7-point Self-measured Plasma Glucose Profiles
week 0, 8, 12 and 16
Change in Beta-cell Function
week 0, week 16
Change in Fasting Lipid Profile
week 0, week 16
+2 more secondary outcomes

Study Arms (4)

Lira 0.6 + Met

EXPERIMENTAL

Liraglutide 0.6 mg + metformin + glimepiride placebo

Drug: liraglutideDrug: placeboDrug: metformin

Lira 1.2 + Met

EXPERIMENTAL

Liraglutide 1.2 mg + metformin + glimepiride placebo

Drug: placeboDrug: liraglutideDrug: metformin

Lira 1.8 + Met

EXPERIMENTAL

Liraglutide + metformin + glimepiride placebo

Drug: placeboDrug: liraglutideDrug: metformin

Glim + Met

EXPERIMENTAL

Glimepiride 4.0 mg + metformin + liraglutide placebo

Drug: glimepirideDrug: metforminDrug: placebo

Interventions

liraglutideDRUG

0.6 mg/day, s.c. (under the skin) injection

Lira 0.6 + Met

placeboDRUG

Glimepiride placebo, capsules

Lira 0.6 + MetLira 1.2 + MetLira 1.8 + Met

glimepirideDRUG

Capsules, 4.0 mg/day

Glim + Met

metforminDRUG

Tablets, 1.5-2.0 g/day

Glim + MetLira 0.6 + MetLira 1.2 + MetLira 1.8 + Met

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 2 diabetes
Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
BMI less than 45.0 kg/m\^2

You may not qualify if:

Treatment with insulin within the last 3 months prior to the trial
Impaired liver or/and renal function
Significant cardiovascular disease over the last 6 months
Known retinopathy or maculopathy
Recurrent major hypoglycaemia or hypoglycaemic unawareness

Contact the study team to confirm eligibility.