Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin.

The registry classes the interventions as drug.

Who Took Part

220 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Diagnosis of type 2 diabetes mellitus for at least one year;. Willingness to accept, and ability to inject insulin glargine therapy.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: stroke, mi, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or angina pectoris within the last 12 months;; acute or chronic metabolic acidosis, including diabetic ketoacidosis;; planned radiological examinations requiring administration of contrasting agents;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2001-01 with completion listed for 2002-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Mean change from baseline in fasting insulin/C-peptide levels, Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids), Mean change from baseline for bodyweight and Health-related quality of life was compared between the baseline visit and the follow-up assessments.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 220 people.

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

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