A Study in Participants With Type 2 Diabetes Mellitus

What Was Tested

In this phase 3 trial, researchers set out to test Exenatide and Dulaglutide.

The participants must also be taking metformin and pioglitazone.

It had four arms (groups): one (experimental), one (experimental), Exenatide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

During the study, if a participant developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, the participant received additional therapeutic intervention or initiation of an alternative antihyperglycemic medication following study drug discontinuation (rescue therapy).

Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified analyses.

Who Took Part

978 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications. Willing to inject subcutaneous (SC) medication up to 2 times per day. Stable weight for 3 months prior to screening.

The full record lists 8 inclusion and 20 exclusion criteria; among the exclusions: type 1 diabetes; hba1c equal to or less than 6.5 before randomization or at randomization; chronic insulin use.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

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

It started in 2010-02 with completion listed for 2011-11.

It ran at 89 sites in United States (78), Puerto Rico (7), Mexico (3) and Argentina (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, 26 weeks).

It also tracked 46 secondary outcomes, for example Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c), Change From Baseline to 26 Weeks for Body Weight, Change From Baseline to 52 Weeks for Body Weight, Change From Baseline to 26 Weeks on Body Mass Index (BMI), Change From Baseline to 52 Weeks on Body Mass Index (BMI) and Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Dulaglutide in 978 people.

With 978 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 Exenatide compound page and the Dulaglutide compound page, all human trials.