An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Glargine.

It had two arms (groups): MK-0941 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 70 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Male or female (of non-childbearing potential) between 18 to 70 years of age. Diagnosed with Type 2 Diabetes and currently being treated with basal insulin. Smokers may participate, but they are limited to 10 cigarettes per day while at the clinic and must follow clinic smoking rules.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: history of type 1 diabetes; treated with peroxisome proliferator-activated receptor (ppar) agonists within 12 weeks prior to study start; history of severe hypoglycemia.

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.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2007-07 with completion listed for 2008-04.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants Who Experienced an Adverse Event During the Study (time frame: 39 days).

It also tracked 4 secondary outcomes, for example Number of Participants Who Experienced an Adverse Event - Titration Scheme 1, Number of Participants Who Experienced an Adverse Event - Titration Scheme 2, 24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7 and Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 70 people.

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.