Efficacy of Pioglitazone and Insulin in Treating Subjects With Type 2 Diabetes Mellitus and Renal Failure.

What Was Tested

This registered phase 2 trial tested Insulin (regular human).

The purpose of this study is to determine the metabolic and cardiovascular effects of pioglitazone, once daily (QD), and insulin combination therapy in subjects with Type 2 Diabetes and Renal Failure.

It had two arms (groups): one (experimental) and Placebo QD (placebo comparator).

(and variable insulin therapy).

(and variable insulin therapy).

The registry classes the interventions as drug.

More on the Plan

The duration of treatment for patients completing the study is approximately 26 weeks.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 30 years up to 80 years.

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

Examples of who could join: Has Type 2 Diabetes Mellitus, and is a patient on insulin treatment for at least 3 months. Has a body mass index less than 36 kg/m². Patient is on hemo-dialysis with or without residual excretion.

The full record lists 5 inclusion and 19 exclusion criteria; among the exclusions: has a history of type 1 diabetes; has acute infections; history of hypersensitivity to the study drugs or to drugs with similar chemical structures.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-08 with completion listed for 2010-06.

It ran at 9 sites in Germany (9).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 24 secondary outcomes, for example Change from Baseline in Glycosylated Hemoglobin, Change from Baseline in Glucose, Change from Baseline in Insulin, Change from Baseline in C-peptide, Change from Baseline in Intact Proinsulin and Change from Baseline in Adiponectin.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 40 people.

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

More context: the Insulin (regular human) compound page, all human trials.