Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Liraglutide.

This trial is conducted in Africa, Asia, Europe and South America.

This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 584 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Type 2 diabetes. Treatment with oral anti-diabetic drugs for at least 3 months. Body Mass Index (BMI) less than or equal to 45 kg/m2.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: treatment with insulin within the last 3 months; treatment with any drug that could interfere with the glucose level; any serious medical condition.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2006-05 with completion listed for 2007-04.

It ran at 116 sites in United Kingdom (12), Italy (10), Spain (10), France (9), Netherlands (8) and Austria (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: after 26 weeks of treatment).

It also tracked 4 secondary outcomes, for example body weight, Safety and tolerability, Beta-cell function and Glycaemic control.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Liraglutide in 584 people.

With 584 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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