A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018)

What Was Tested

In this phase 2 trial, researchers set out to test Insulin (regular human).

The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes.

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

Participants receiving placebo tablets three times daily plus insulin injection once daily.

The registry classes the interventions as drug.

Who Took Part

The registry lists 68 actual participants took part.

It was open to people of any sex aged from 21 years up to 70 years.

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

Examples of who could join: Participant has Type 2 Diabetes Mellitus.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: participant has a history of type 1 diabetes mellitus or ketoacidosis; participant is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication; participant has had surgery within 30 days of starting the study or has planned major surgery.

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 (regular human) group and the comparison group should start out alike.

The Insulin (regular human) 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 (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2009-01 with completion listed for 2010-05.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) Level (time frame: Baseline (Day 1) and End of Treatment (Week 20)). Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 68 people.

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

More context: the Insulin (regular human) compound page, all human trials.