Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide.

A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content.

It had two arms (groups): 1 (placebo comparator) and 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 80 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Patients between 18 and 85 years of age, inclusive. Patients with type 2 diabetes. Patients have a history of stable body weight (not varying by \>2 kg in the 3 months prior to Visit 1). Medications for the treatment of high blood pressure are stable with respect to treatment regimen for 4 weeks prior to Visit 1. Stable regimen of lipid-lowering agents for 6 weeks prior to Visit 1.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: have a history of renal transplantation, or are currently receiving renal dialysis; known or are likely to become transfusion dependent during the study; have active, symptomatic proliferative retinopathy.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

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

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2008-08 with completion listed for 2012-01.

It ran at 17 sites in Canada (12) and United States (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months (time frame: baseline, 6 months).

It also tracked 12 secondary outcomes, for example Percentage Change in Total Abdominal Fat From Baseline to 6 Months, Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months, Change in HbA1c From Baseline to 6 Months, Change in Fasting Plasma Glucose From Baseline to 6 Months, Change in Weight From Baseline to 6 Months and Change in Systolic Blood Pressure From Baseline to 6 Months.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 80 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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