Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Insulin Aspart.

This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

It had two arms (groups): BIAsp 30 (experimental) and Glargine (active comparator).

The registry classes the interventions as drug.

Who Took Part

480 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 2 diabetes. Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months. Ongoing stable treatment with metformin for at least 2 months.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: metformin contraindication according to local practice; TZD (thiazolidinedione) treatment for the last 5 months before trial start; systemic treatment with any corticosteroid 3 months before trial start.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

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

It started in 2007-05 with completion listed for 2008-04.

It ran at 69 sites in Poland (14), France (6), Austria (5), Netherlands (5), Romania (5) and Argentina (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glycosylated Haemoglobin A1c (HbA1c) (time frame: After 26 weeks of treatment).

It also tracked 5 secondary outcomes, for example 9-point Self-measured Plasma Glucose Profiles, Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c), Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat), Number of Hypoglycaemic Episodes and Number of Subjects Reporting Treatment Emergent Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 480 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 and the Insulin Aspart compound page, all human trials.