Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Liraglutide.

It had seven arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

254 actual participants took part.

It was open to people of any sex aged from 18 years up to 74 years.

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

Examples of who could join: Ages eligible for study : 18 years to 74 years. Genders eligible for study : Male and Female. Diagnosed with T2DM. Received diet and exercise therapy with or without metformin monotherapy. Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: pregnant or nursing (lactating) women; diagnosis of type 1 diabetes mellitus; any history of gi intolerance.

How the Study Was Run

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

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

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

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2014-01 with completion listed for 2014-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks (time frame: Up to 127 days).

It also tracked 6 secondary outcomes, for example Fasting plasma glucose levels (FPG), 7-point glucose profile, Other glycaemic control parameters, Serum lipid profile and Body weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 254 people.

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

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