In-patient Study in Patients With Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 1) is built around Exenatide.

This study is a placebo-controlled study in both healthy normal subjects and patients with Type 2 Diabetes Mellitus to assess the levels of exenatide in the bloodstream when it is given for 7 days, and to assess the impact this medication has on various substances in the blood.

Assessments include repeat blood sampling and monitoring of any side effects.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 66 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Have type 2 diabetes mellitus that has been diagnosed for at least three months. Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea. Must be willing to wash-out of these medications for 14 days prior to the start of the study.

The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: must not have any other major illness other than diabetes.

How the Study Was Run

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

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Being open-label, the Exenatide study did not mask who received what.

It started in 2005-10.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 30 people.

Its size is small, so on its own it can only give an early look.

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

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