Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin

What Was Tested

The trial (phase 4) is built around Insulin Detemir and NPH Insulin (isophane).

For this reason three different standardized test meals (breakfast, lunch, dinner) will be performed and the postprandial secretion of intact proinsulin levels will be measured.

It had three arms (groups): Insulin glargine (active comparator), NPH Insulin (active comparator) and Insulin detemir (active comparator).

The registry classes the interventions as drug.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Type 2 Diabetes mellitus according to the ADA criteria. Age between 40 and 75 years.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: type 1 diabetes mellitus; pre-treatment with insulin within the last 3 months prior to screening; pre-treatment with ppary-agonists (glitazones) within the last 3 months prior to screening.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Detemir group and the comparison group should start out alike.

The Insulin Detemir group and the comparison group ran side by side rather than switching.

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

It started in 2008-04 with completion listed for 2009-03.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): postprandial dynamics of intact proinsulin secretion after standardized test meals (AUC for two hours after dinner) (time frame: 12 +/- 2 weeks).

It also tracked 11 secondary outcomes, for example AUC for intact proinsulin levels for two hours after a standardized test meal (breakfast and lunch), Ratio of exogenous insulin vs. endogenous insulin (measurements of glargine, NPH Insulin, detemir and human insulin levels), Postprandial endothelial function measured as postischaemic response in LDF measurements (after BF, LU, DI), Postprandial change in and AUC for hs CRP (after BF, LU, DI), Postprandial change in and AUC for ADMA (after BF, LU, DI) and Changes in FBG.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 30 people.

Its size is small, so on its own it can only give an early look.

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 and the NPH Insulin (isophane) compound page, all human trials.