Insulin Glulisine in Diabetes Mellitus, Type 2

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

Mealtime insulin glulisine 3x daily and insulin glargine 1 x daily subcutaneously.

Two daily injection conventional insulin therapy.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 311 actual participants took part.

It was open to people of any sex aged from 18 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, as defined by the American Diabetes Association for at least five years, treated with insulin for at least 6 months (no history of ketoacidosis). Documentation of a full ophthalmologic exam (incl. fundoscopy)during the 6 months prior to randomization. Willing and able to perform specified home blood glucose monitoring and to otherwise comply with study protocol requirements. Willing to change from a twice daily insulin regimen to a regimen requiring four daily insulin injections.

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: history of hypoglycemia unawareness; body mass index (bmi) \> 38 kg/m2; history of hypersensitivity to insulin or insulin analogues or any of the excipients in the hmr 1964 formulation.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2004-11 with completion listed for 2007-11.

It ran at 15 sites in Australia (1), Belgium (1), Czechia (1), France (1), Germany (1) and Italy (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: From baseline to study endpoint). Self monitored BG (SMBG) values (time frame: During the whole treatment phase). Body weight/body mass index (BMI) (time frame: From baseline to study endpoint and all other visits).

It also tracked 4 secondary outcomes, for example Adverse events, Standard laboratory tests, Vital signs and Physical examination.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 311 people.

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

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