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Exenatide and Weight Loss for Diabetes Prevention
Plain-language guide to NCT02084654: phase 1 randomized trial of Exenatide, insulin resistance, prediabetes & type 2 diabetes, 66 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02084654
- Phase
- phase 1
- Status
- completed
- Start
- 2007-11
- Completion (planned or actual)
- 2012-10
- Participants
- 66 (actual)
- Design
- randomized, triple-blind
- Conditions studied
- Pre Diabetes; Insulin Resistance
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Exenatide for insulin resistance, prediabetes & type 2 diabetes.
The investigators will seek to determine whether exenatide would have similar effects in individuals who were not diabetic. in particular, the drug effect on beta cell function and insulin sensitivity would be subject to less confounding by changes in blood glucose in the prediabetic population, allowing for clearer evaluation of the physiological effects of the drug on these metabolic endpoints.
It had two arms (groups): one (active comparator) and placebo (placebo comparator).
Placebo in addition to weight loss.
The registry classes the interventions as drug.
Who Took Part
66 actual participants took part.
It was open to people of any sex aged from 30 years up to 70 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 1 inclusion and 1 exclusion criteria.
How the Study Was Run
It was run as a randomized, parallel-group and triple-blind study.
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.
Groups ran in parallel: each of the insulin resistance, prediabetes & type 2 diabetes participants stayed in one arm throughout.
Blinding on both sides kept the insulin resistance, prediabetes & type 2 diabetes participants and researchers unaware of who received Exenatide.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2007-11 with completion listed for 2012-10.
What Was Measured
Primary outcome: First-phase insulin response (time frame: 7 months).
It also tracked 1 secondary outcome, for example glucose lowering effect.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Exenatide in 66 people with insulin resistance, prediabetes & type 2 diabetes.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Exenatide compound page, Insulin resistance, prediabetes & type 2 diabetes research.
Our Notes on the Compound
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.