Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment

What Was Tested

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

This trial is conducted in Asia.

The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before.

The trial is conducted as a phase 4 trial in China and phase 3 in Japan.

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

The registry classes the interventions as drug.

Who Took Part

521 actual participants took part.

It was open to people of any sex aged from 20 years up to 79 years.

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

Examples of who could join: Body Mass Index (BMI) below 40.0 kg/m\^2.

The full record lists 7 inclusion and 3 exclusion criteria; among the exclusions: treatment with any thiazolidinedione (tzd) and glp-1 (glucagon like peptide-1) receptor antagonists during the last 3 months before visit 1 in this trial; any disease or condition which the investigator feels would interfere with the trial; any contraindication to metformin or glimepiride (according to local labelling).

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 Glargine and who got the comparison, which limits bias.

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 2010-05 with completion listed for 2011-06.

It ran at 34 sites in China (21) and Japan (13).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, week 24).

It also tracked 6 secondary outcomes, for example 9-point Plasma Glucose Profiles, Number of Hypoglycaemic Episodes - All, Number of Hypoglycaemic Episodes - Severe and Minor and Number of Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 521 people.

With 521 participants it is a large trial for this field.

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.