Brief Summary

This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial.

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

987

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Mar 2009

Typical duration for phase_3 diabetes

Geographic Reach

10 countries

233 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

1.7 years study duration

Study Start

First participant enrolled

March 1, 2009

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed

6 months until next milestone

Results Posted

Study results publicly available

May 13, 2011

Completed

Last Updated

March 8, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

March 5, 2009

Results QC Date

April 19, 2011

Last Update Submit

January 25, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.
Week 0 (Randomisation), week 26

Secondary Outcomes (31)

Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)
Week 0, Week 52
Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)
Week 0, Week 52
Mean Change From Randomisation in Fasting Plasma Glucose at Week 26
Week 0 (Randomisation), Week 26
Mean Change From Randomisation in Fasting Plasma Glucose at Week 52
Week 0, Week 52
Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26
Week 0 (Randomisation), Week 26
+26 more secondary outcomes

Study Arms (5)

Lira 1.8

EXPERIMENTAL

Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%

Drug: liraglutideDrug: metformin

Insulin detemir + Lira 1.8

EXPERIMENTAL

Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%

Drug: liraglutideDrug: insulin detemirDrug: metformin

Non-Randomised Lira 1.8

EXPERIMENTAL

Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%

Drug: liraglutideDrug: metformin

Early Withdrawals Lira 1.8

OTHER

Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial

Drug: liraglutideDrug: metformin

Intensified group

OTHER

Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.

Drug: liraglutideDrug: insulin detemirDrug: metformin

Interventions

liraglutideDRUG

Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection.

Early Withdrawals Lira 1.8Insulin detemir + Lira 1.8Intensified groupLira 1.8Non-Randomised Lira 1.8

insulin detemirDRUG

Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a pre-specified algorithm

Insulin detemir + Lira 1.8Intensified group

metforminDRUG

Metformin tablets, at least 1500 mg/day

Early Withdrawals Lira 1.8Insulin detemir + Lira 1.8Intensified groupLira 1.8Non-Randomised Lira 1.8

Eligibility Criteria

Age18 Years - 84 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for at least 3 months prior to screening, at a stable dose of at least 1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal to half of the maximum approved dose), both at a stable dose for at least 3 months prior to screening. Previous short-term insulin treatment in connection with intercurrent illness is allowed at the discretion of the Investigator
HbA1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy
HbA1c 7.0-8.5% (both inclusive) for subjects on metformin in combination with a sulphonylurea

You may not qualify if:

Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator)
Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
Impaired kidney function
Impaired liver function
Uncontrolled treated/untreated hypertension
Cancer or any clinically significant disease or disorder as judged by the Investigator
Previous participation in the run-in phase of this trial. Re-screening is allowed once
History of chronic pancreatitis or idiopathic pancreatitis

Contact the study team to confirm eligibility.