Effect of Different Insulin Administrations, All in Combination With Metformin, on Glycaemic Control in Subjects With Type 2 Diabetes Inadequately Controlled by Oral Anti-diabetic Drugs

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Aspart and Insulin Detemir.

This trial is conducted in Africa.

It had two arms (groups): Detemir + Met (active comparator) and BIAsp 30 + Met (active comparator).

The registry classes the interventions as drug.

Who Took Part

403 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: Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). Diagnosed type 2 diabetes (WHO 1999 criteria). Male or female age at least 18 years old. BMI maximum 40 kg/m\^2. Able and willing to perform self-monitoring of plasma glucose according to the protocol and to keep a diary.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: known or suspected allergy to trial product(s) or related products; previous participation in this trial. participation is defined as randomisation; participated in another clinical trial and received an investigational drug within the last weeks prior to the present trial.

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 Aspart group and the comparison group should start out alike.

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

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-03 with completion listed for 2012-05.

It ran at 19 sites in South Africa (10), Algeria (6), Egypt (1), Morocco (1) and Tunisia (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glycosylated Haemoglobin (HbA1c) (time frame: Week 50).

It also tracked 16 secondary outcomes, for example Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment, Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment, Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment, Change in Glycosylated Haemoglobin (HbA1c) at Week 50, Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment and Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Detemir in 403 people.

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

More context: the Insulin Aspart compound page and the Insulin Detemir compound page, all human trials.