Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 1 trial tested Exenatide.

It had three arms (groups): A (experimental), B (active comparator) and C (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 36 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Diagnosis of Type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve). ALT ≤ 1.5 x ULN and total bilirubin ≤ 2 x ULN. Stable and well controlled hypertension and/or dyslipidemia.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: women of childbearing potential; symptomatic diabetes with polyuria and/or polydipsia; history of diabetic ketoacidosis or hyperosmolar nonketotic syndrome.

How the Study Was Run

Design: randomized, crossover and double-blind.

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

In the crossover set-up each of the participants took both Exenatide and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

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

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Safety: incidence of adverse events (time frame: from subject enrollment to study discharge).

It also tracked 2 secondary outcomes, for example PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide 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 Exenatide compound page, all human trials.