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Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
Plain-language guide to NCT02229383: phase 3 randomized trial of Exenatide, 464 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02229383
- Phase
- phase 3
- Status
- completed
- Start
- 2014-09-06
- Completion (planned or actual)
- 2016-08-29
- Participants
- 464 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Exenatide.
It had two arms (groups): Exenatide (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 464 actual participants took part.
It was open to people of any sex aged from 18 years up to 130 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Has a diagnosis of Type 2 Diabetes Mellitus (T2DM).
The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: serum calcitonin concentration ≥40 pg/ml (≥40 ng/l) at visit 1 (screening); positive serological test for hepatitis b or hepatitis c.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.
The Exenatide group and the comparison group ran side by side rather than switching.
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 2014-09-06 with completion listed for 2016-08-29.
It ran at 123 sites in United States (68), Hungary (17), Slovakia (12), Romania (10), Poland (8) and South Africa (8).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change in HbA1c From Baseline to Week 28 (time frame: Baseline to Week 28).
It also tracked 6 secondary outcomes, for example Change in Body Weight From Baseline to Week 28, Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT) and Change in Seated Systolic Blood Pressure From Baseline to Week 28.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Exenatide in 464 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.
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.