Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes

What Was Tested

This registered phase 2, phase 3 trial tested Exenatide.

It had two arms (groups): exenatide (experimental) and Placebo (placebo comparator).

55 subjects.

55 subjects.

The registry classes the interventions as drug.

Who Took Part

110 planned participants were the target.

It was open to people of any sex aged from 35 years up to 70 years.

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

Examples of who could join: Men or women aged 35 to 70. Type 2 diabetes diagnosed for at least 12 months, according the criteria of the American Diabetes Association :. BMI ≥ 25 and ≤ 45.

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: type 1 diabetes assessed by positive anti-gad65 or anti-insulin or anti-ia2 antibodies; monogenic diabetes (mody, mitochondrial diabetes…); current treatment with oha (oha ought to be interrupted at least two months prior to inclusion in the study).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

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, care provider, investigator and outcomes assessor.

It started in 2010-11 with completion listed for 2017-05.

It ran at 3 sites in France (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline to 6 months of centrally measured HbA1c (time frame: baseline to 6 months).

It also tracked 2 secondary outcomes, for example Change from baseline in mean blood glucose value.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Exenatide in 110 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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