Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Exenatide and Insulin Glargine.

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

It had two arms (groups): Exenatide Arm (experimental) and Insulin Glargine Arm (active comparator).

Exenatide and Metformin.

Insulin Glargine and Metformin.

The registry classes the interventions as drug.

Who Took Part

69 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Diagnosis of type 2 diabetes, but otherwise healthy. Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: patients previously in a study using exenatide; treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening); treated with insulin within 3 months of screening.

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 2004-09 with completion listed for 2009-12.

It ran at 3 sites in Finland (1), Netherlands (1) and Sweden (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Beta-cell Function After 52 Weeks of Therapy (time frame: Baseline (week -2) and 52 weeks).

It also tracked 8 secondary outcomes, for example Beta-cell Function 4 Weeks After Cessation of Therapy, Change in First Phase C-peptide Release, Change in Second Phase C-peptide Release, Change in Glycosylated Hemoglobin (HbA1c), Change in Fasting Plasma Glucose and Seven Point Self Monitored Blood Glucose (SMBG) Measurements.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin Glargine in 69 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 and the Insulin Glargine compound page, all human trials.