Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Aspart.

This trial is conducted in Asia.

The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.

It had two arms (groups): BIAsp 30 (experimental) and BHI 30 (experimental).

The registry classes the interventions as drug.

Who Took Part

145 actual participants took part.

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: Type 2 diabetes diagnosed for at least 6 months. Insulin-naive (less than or equal to 1 week of daily use of insulin therapy). Treatment with metformin as monotherapy or in combination therapy with other OAD(s) for at least 3 months prior to this trial. Body Mass Index (BMI) between 18.5 - 35.0 kg/m\^2. Be able and willing to perform continuous glucose monitoring system (CGMS ) and self-monitored blood glucose (SMBG).

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: known or suspected allergy to trial product(s) or related products; any contraindication of metformin; receipt of investigational drug within the last 3 months prior to this trial.

How the Study Was Run

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

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.

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

It started in 2008-12 with completion listed for 2009-10.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals (time frame: Week 0, week 6).

It also tracked 11 secondary outcomes, for example Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS, Mean FBG (Fasting Blood Glucose) Assessed by CGMS, Change in Mean FBG Assessed by CGMS, Change in FPG (Fasting Plasma Glucose), Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles and Change in Prandial Blood Glucose Increment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 145 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, all human trials.