Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes

What Was Tested

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

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

Pioglitazone.

Insulin glargine.

The registry classes the interventions as drug.

More on the Plan

The patients' satisfaction with each treatment was also surveyed.

Who Took Part

The registry lists 36 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Type 2 diabetes.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: heart failure (nyha ii-iv).

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2004-04 with completion listed for 2006-12.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity (time frame: 26 weeks).

It also tracked 1 secondary outcome, for example Effect of pioglitazone vs. insulin glargine on BNP.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 36 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 Glargine compound page, all human trials.