A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide.

All drugs will be given by an injection under the skin.

It had six arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Exenatide extended-release (experimental).

The registry classes the interventions as drug.

More on the Plan

The study will include a 12 week blinded treatment period, where neither the participant nor the investigator will know to which treatment each individual is assigned.

Thereafter follows a 12 week period where participants and the investigator will know which treatment they are assigned to.

Participants' on LY2944876 and on exenatide extended-release continue treatment in this period, those who received placebo will be followed without treatment.

Who Took Part

420 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: Men or women with diabetes mellitus Type 2. Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: women of child bearing potential; participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year.

How the Study Was Run

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

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2014-04 with completion listed for 2015-08.

It ran at 51 sites in United States (31), Poland (7), Romania (5), Greece (3), Mexico (3) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 (time frame: Baseline, Week 12).

It also tracked 14 secondary outcomes, for example Change From Baseline in HbA1c at Week 24, Percent Change From Baseline in Body Weight, Change From Baseline in Fasting Blood Glucose, Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values, Change From Baseline in Lipids and Change From Baseline in Fasting Fibroblast Growth Factor 21.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 420 people.

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

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