A Comparison of Exenatide and Insulin Glargine

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide and Insulin Glargine.

This is a 16-week, Single-center, Randomized, Open Label, Parallel Controlled Group Comparison of the Comprehensive Glycemic Control of Exenatide and Insulin Glargine on Type 2 Diabetes Patients Inadequately Controlled With Metformin Monotherapy.

It had two arms (groups): exenatide (active comparator) and Insulin glargine (active comparator).

The registry classes the interventions as drug.

More on the Plan

Insulin glargine will be administered once daily at bedtime by subcutaneous injection.

Titration is only allowed in first 4 weeks.

At the end of the study, data will be collected and analyzed.

Who Took Part

The registry lists 44 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Provision of informed consent prior to any study specific procedures. Male or female age ≧ 18 years and ≦70 years old. BMI ≧ 24 kg/m2.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: known or suspected allergy to trial products or related products; acute or chronic disease which may cause tissue hypoxia such as respiratory failure or shock; abnormal liver function, alanine transaminase or aspartate aminotransferase ≥ 3 fold normal upper limit, total bilirubin ≥ 2 normal upper limit, acute alcohol intoxication, alcoholism.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

It started in 2015-01 with completion listed for 2016-07.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean amplitude of glycemic excursions (MAGE) change from baseline by continuous glucose monitoring system (CGMS) (time frame: 1±3day；112±3d).

It also tracked 7 secondary outcomes, for example Glycemic variability, Glucose control, oxidative stress markers, inflammatory markers, endothelial function and beta-cell function and insulin resistance.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Glargine in 44 people.

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

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