Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes

What Was Tested

The trial (phase 2) is built around Insulin Glargine.

It had three arms (groups): 1 (experimental), 2 (placebo comparator) and 3 (active comparator).

Colesevelam matching placebo for 12 weeks.

Open-label Insulin Glargine for 12 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Patients between the ages of 18 - 75, inclusive. Diagnosed with type 2 diabetes. Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn). Overweight, obese (body mass index 25-45 kg/m2).

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: previous treatment with colesevelam for hyperlipidemia.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.

Those kept unaware of assignments: participant and care provider.

It started in 2005-06 with completion listed for 2008-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine in 36 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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