A Study To Assess GW677954 Used In Combination With Insulin In Subjects Who Have Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 2) is built around Insulin (regular human).

Many drugs used for the treatment of Type 2 Diabetes Mellitus cause the body to retain water.

This study will assess whether or not GW677954 causes the body to retain fluid.

The registry classes the interventions as drug.

Who Took Part

The registry lists 1 actual participants took part.

It was open to people of any sex aged from 30 years up to 65 years.

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

Examples of who could join: Have been diagnosed by a doctor with Type 2 Diabetes Mellitus at least 3 months before Screening. Have a body mass index within range 25 to 40.0kg/m2 inclusive. Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition).

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: have used insulin to treat hyperglycemia within 3 months before screening; have a history of fluid retention; have uncontrolled high blood pressure.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2006-09 with completion listed for 2006-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight (time frame: up to 24 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 1 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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