The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Detemir and Liraglutide.

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.

It had five arms (groups): Lira 1.8 (experimental), Insulin detemir + Lira 1.8 (experimental), Non-Randomised Lira 1.8 (experimental), Early Withdrawals Lira 1.8 (other) and Intensified group (other).

The registry classes the interventions as drug.

Who Took Part

The registry lists 987 actual participants took part.

It was open to people of any sex aged from 18 years up to 84 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the investigator); treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening; recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the investigator.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin Detemir study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin Detemir was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2009-03 with completion listed for 2010-04.

It ran at 233 sites in United States (60), Germany (39), United Kingdom (32), Spain (25), France (24) and Italy (21).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 (time frame: Week 0 (Randomisation), week 26).

It also tracked 31 secondary outcomes, for example Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group), Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF), Mean Change From Randomisation in Fasting Plasma Glucose at Week 26, Mean Change From Randomisation in Fasting Plasma Glucose at Week 52, Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26 and Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Detemir and Liraglutide in 987 people.

With 987 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Detemir compound page and the Liraglutide compound page, all human trials.