Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

467

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Aug 2007

Typical duration for phase_3 diabetes

Geographic Reach

15 countries

121 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

August 1, 2007

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed

12 months until next milestone

Results Posted

Study results publicly available

March 23, 2010

Completed

Last Updated

March 8, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

August 20, 2007

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 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

Secondary Outcomes (54)

Change in Glycosylated A1c (HbA1c), Weeks 26-78
week 26, week 78
Change in Glycosylated A1c (HbA1c) at Week 78
week 0, week 78
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 26
week 0, week 26
Percentage of Subjects Achieving Treatment Target of Either HbA1c < 7.0% or =< 6.5% at Week 78
week 0, week 78
Change in Body Weight at Week 26
week 0, week 26
+49 more secondary outcomes

Study Arms (2)

Liraglutide

EXPERIMENTAL

Liraglutide 1.8 mg once daily + subject's own OAD treatment

Drug: liraglutide

Exenatide

ACTIVE COMPARATOR

Exenatide 10 mcg twice daily + subject's own OAD treatment

Drug: exenatide

Interventions

liraglutideDRUG

1.8 mg once daily for s.c. (under the skin) injection.

Liraglutide

exenatideDRUG

10 mcg twice daily for s.c. (under the skin) injection.

Exenatide

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes
Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator
HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%
Body Mass Index (BMI) equal to or lower than 45.0 kg/m2

You may not qualify if:

Previous treatment with insulin
Treatment with any anti-diabetic drug other than metformin and sulphonylurea
Any previous exposure to exenatide or liraglutide
Impaired liver or/and renal function
History of any significant cardiac events
Known retinopathy or maculopathy requiring acute treatment
Recurrent major hypoglycaemia or hypoglycaemic unawareness

Contact the study team to confirm eligibility.