Insulin Glargine in Type 2 Diabetic Patients

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

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

Administration of Insulin Glargine and Sulfonylurea or Metformin.

Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin.

The registry classes the interventions as drug.

Who Took Part

387 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Type 2 diabetes patients with first OAD (Sulfonylurea \[SU\] or Metformin) failure. Patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week). BMI: 21-41 kg/m². Women not of childbearing potential (sterilization procedure done or menopausal \> 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study. Able and willing to monitor blood glucose.

The full record lists 11 inclusion and 8 exclusion criteria; among the exclusions: type 1 diabetes; acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma; pregnancy, breast-feeding.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

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

It started in 2006-06 with completion listed for 2008-05.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): A1c values (time frame: At baseline and 24 weeks).

It also tracked 1 secondary outcome, for example Adverse events including hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 387 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.