A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension

What Was Tested

This registered phase 1, phase 2 trial tested Exenatide.

Development of this exenatide once weekly presentation would eliminate the need to reconstitute the product prior to use.

It had three arms (groups): Cohort 1: Healthy Participants (experimental), Cohort 2: Diabetes Participants (experimental) and Cohort 2: Diabetes Participants Placebo (placebo comparator).

On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, thiazolidinedione (TZD), or a combination of metformin or TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks.

On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, thiazolidinedione (TZD), or a combination of metformin or TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 65 actual participants took part.

It was open to people of any sex aged from 19 years up to 75 years.

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

Examples of who could join: Is 19 to 65 years old. Has a body mass index (BMI) of 23 kg/m2 to 35 kg/m2, inclusive, at study start. Is 19 to 75 years old. Has been diagnosed with type 2 diabetes mellitus. Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at study start.

The full record lists 14 inclusion and 11 exclusion criteria; among the exclusions: has a personal history of diabetes mellitus (including impaired glucose tolerance, impaired fasting glucose, or gestational diabetes); has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start; has ever been exposed to exenatide (byetta, exenatide once weekly, or any other formulation of exenatide) or any glp 1 analog.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

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

In this single-blind Exenatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2009-04 with completion listed for 2009-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Concomitant Medications in Cohort 1 and Cohort 2 in ITT Population (time frame: Day 1 to 12 weeks). Mean Change From Baseline to End of Study in Sitting Diastolic and Systolic Blood Pressure in Cohorts 1 and 2 in ITT Population (time frame: Day 1 to Week 12). Mean Change From Baseline to End of Study in Sitting Heart Rate in Cohorts 1 and 2 in ITT Population (time frame: Day 1 to Week 12).

It also tracked 6 secondary outcomes, for example Least Square Mean Change From Baseline in Hemoglobin A1c (HbA1c) to Week 12 in Participants With Diabetes (Cohort 2) in the ITT Population, Mean Change From Baseline at Week 12 in Body Weight in Participants With Diabetes (Cohort 2) in the ITT Population and Mean Change From Baseline at Week 12 in Fasting Plasma Glucose in Participants With Diabetes (Cohort 2) for the ITT Population.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Exenatide in 65 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.