Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes

What Was Tested

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

This trial is conducted in Africa and Middle East.

The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.

The registry classes the interventions as drug.

Who Took Part

79 actual participants took part.

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

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

Examples of who could join: Type 2 diabetic subjects. Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial. Willing and able to perform self blood glucose monitoring (SMBG).

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: history of drug or alcohol dependence; receipt of any investigational drug within the last month prior to this trial; severe uncontrolled hypertension.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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 2006-02 with completion listed for 2006-08.

It ran at 4 sites in Egypt (2) and Saudi Arabia (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c (time frame: At Visit 6 (14 weeks)).

It also tracked 1 secondary outcome, for example Postprandial glucose concentration increments (calculated based on 7-point blood glucose profiles).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 79 people.

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

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