A Study for Type 2 Diabetic Patients

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine and Insulin Lispro.

The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level.

It had two arms (groups): Insulin lispro low mixture (experimental) and Insulin glargine (active comparator).

Insulin lispro low mixture (1, 2 or 3 daily injections).

Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 426 actual participants took part.

It was open to people of any sex aged from 30 years up to 79 years.

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

Examples of who could join: Type 2 diabetes mellitus. Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days. Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications. Able to perform self monitoring of blood glucose.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: are taking any other glucose-lowering agents other than metformin, sulfonylurea or thiazolidinedione (pioglitazone); have a body mass index greater than 35 kg/m2; history or presence of kidney disease.

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.

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

It started in 2007-11 with completion listed for 2009-08.

It ran at 25 sites in Canada (6), India (5), Brazil (4), Australia (3), China (3) and Mexico (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c) (time frame: Baseline, 48 weeks).

It also tracked 8 secondary outcomes, for example Change in Hemoglobin A1c (HbA1c) Over Time, 7-point Self-monitored Blood Glucose Profiles, Change From Baseline in Postprandial Blood Glucose Over Time, Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles and Safety: Number of Participants With Serious and Non-Serious Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 426 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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