Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin (regular human) and Insulin Aspart.

This trial is conducted in Asia.

It had two arms (groups): Insulin detemir / IAsp (experimental) and insulin NPH (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 58 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: Type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer. Body Mass Index (BMI) equal to 40 kg/m\^2 or below. Plan to be admitted for optimising glycaemic control at least 2 days prior to the randomisation.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: treatment with thiazolidinediones (tzd) or glucagon-like peptide-1 (glp-1) receptor agonists within the last 3 months prior to the screening; anticipated change after the randomisation in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and mono amine oxidase (mao) inhibitors; previous participation in this trial (participation is defined as randomised. re-screening of screening failures is allowed only once within the limits of the recruitment period.).

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) 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 (regular human) study: the participants and staff both knew the treatment.

It started in 2011-11 with completion listed for 2012-06.

It ran at 6 sites in China (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment (time frame: Week 0, week 2).

It also tracked 9 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment, Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment, Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment, Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment, Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment and Change From Baseline in Fructosamine After Two Weeks of Treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Aspart in 58 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page and the Insulin Aspart compound page, all human trials.