Safety and Efficacy of Insulin Detemir in Combination With OADs in Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Insulin Detemir.

This trial is conducted in Asia.

The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.

The registry classes the interventions as drug.

Who Took Part

132 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 for at least 12 months since diagnosis. Insulin naive subjects. OAD treatment for at least 4 months with max. two OAD treatments. Body mass index below 30.0 kg/m2.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: OAD treatment with three or more OADs; secondary diabetes; known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the investigator.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Being open-label, the Insulin Detemir study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2004-04 with completion listed for 2004-12.

It ran at 5 sites in India (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: after 20 weeks of treatment).

It also tracked 4 secondary outcomes, for example Fasting plasma glucose (FPG), Within-subject variation, Change in body weight and Incidence of adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Insulin Detemir in 132 people.

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

More context: the Insulin Detemir compound page, all human trials.