Efficacy and Safety of Repaglinide Combined With Insulin in Type 2 Diabetes

What Was Tested

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

This trial is conducted in Asia.

The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.

It had two arms (groups): Rep + NPH (experimental) and Premixed insulin/NPH (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 159 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive).

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: medical history of treatment with insulin within the last 6 months.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Insulin (regular human) 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 (regular human) study: the participants and staff both knew the treatment.

It started in 2002-09-19 with completion listed for 2003-04-10.

It ran at 3 sites in China (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c.

It also tracked 2 secondary outcomes, for example Change in FBG (Fasting Blood Glucose) and Change in body weight.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 159 people.

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

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