Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus

What Was Tested

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

This trial is conducted in Asia.

It had two arms (groups): Treatment sequence 1 (Group A) (experimental) and Treatment sequence 2 (Group B) (experimental).

Group A will receive BIAsp 50 BID during the first 4 weeks (treatment period 1) then switch to BHI 50 BID for further 4 weeks (treatment period 2).

Group B will receive BHI 50 BID during the first 4 weeks (treatment period 1), then switch to BIAsp 50 BID for further 4 weeks (treatment period 2).

The registry classes the interventions as drug.

Who Took Part

The registry lists 161 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 mellitus (diagnosed clinically) for at least 12 months. Currently treated with premixed human insulin 50 BID for at least 3 months prior to screening visit (Visit 1).

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: previous use of any insulin other than premixed human insulin 50 bid within 3 months prior to visit 1; previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (csii)) for more than 14 days.

How the Study Was Run

Design: randomized, crossover and open-label.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

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 2013-06 with completion listed for 2014-05.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test (time frame: After 4 weeks of treatment in each treatment sequence).

It also tracked 6 secondary outcomes, for example -1-hour PPG Increment Following a Standard Meal Test, -IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test, 2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile, The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile, Incidence of Hypoglycemic Episodes and Incidence of AEs (Adverse Event).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 161 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.