Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Insulin Lispro.

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

Administration of Insulin Glulisine.

Administration of Lispro.

The registry classes the interventions as drug.

Who Took Part

The registry lists 485 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: Type 1 or type 2 diabetic patients. More than 3 months of continuous insulin treatment immediately prior to study entry.

The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: pregnant women.

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 Glargine 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 Glargine study: the participants and staff both knew the treatment.

It started in 2007-01 with completion listed for 2008-06.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hypoglycemic episodes (time frame: From the beginning to end of the study). Change in HbA1c (time frame: From baseline to endpoint). Adverse events (time frame: From the beginning to the end of study).

It also tracked 2 secondary outcomes, for example Change in HbA1c.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 485 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 and the Insulin Lispro compound page, all human trials.