Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

What Was Tested

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

This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode.

Patients will be treated with study therapy for approximately 26 weeks.

It had two arms (groups): Exenatide Twice Daily (BID) (experimental) and Premixed Insulin Aspart Twice Daily (BID) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 494 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Have a body mass index (BMI) between 25 kg/m\^2 and 40 kg/m\^2, inclusive.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: have type 1 diabetes or known latent autoimmune diabetes in adults; are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics); have used any prescription drug to promote weight loss within 3 months prior to study start.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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

It started in 2007-02 with completion listed for 2009-06.

It ran at 39 sites in Germany (39).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline and 26 weeks). Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode) (time frame: 26 weeks).

It also tracked 10 secondary outcomes, for example 7 Point Self-monitored Blood Glucose (SMBG) Profiles, Blood Lipid Levels, Change in Body Weight, Change in Body Mass Index (BMI), Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Patient Reported Outcomes: Quality of Life (SF-12).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin Aspart in 494 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 Aspart compound page, all human trials.