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Safety Evaluation of Adverse Reactions in Diabetes
Plain-language guide to NCT02092597: phase 4 randomized trial of Exenatide, 42 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02092597
- Phase
- phase 4
- Status
- completed
- Start
- 2013-10
- Completion (planned or actual)
- 2015-10
- Participants
- 42 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Exenatide.
The purpose of this study is to assess the effects of incretin-based antidiabetic therapies (DPP-4 inhibitors and GLP-1 agonists) on cardiovascular, gastrointestinal and renal system and to detail the mechanisms underlying their action in these systems.
It had three arms (groups): GLP-1 agonist (active comparator), DPP-4 inhibitor (active comparator) and Sulfonylurea derivate (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 42 actual participants took part.
It was open to people of any sex aged from 35 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes mellitus. BMI 25-40 kg/m2. Age 35-70 years (women postmenopausal). Use of ACE inhibitors or ATII receptor blockers for at least 3 months before enrollment.
The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: treatment with incretin mimetics during 3 months before enrollment; chronic insulin therapy; chronic use of loop diuretics, glucocorticoids, nsaid, immune suppressants, antimicrobial agents, chemotherapeutics, bile acid sequestrants (colestyramin, colesevelam).
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.
The Exenatide group and the comparison group ran side by side rather than switching.
Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2013-10 with completion listed for 2015-10.
It ran at 1 site in Czechia.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Heart rate (time frame: 90 days after treatment initiation). Gastric evacuation velocity (time frame: 90 days after treatment initiation). Blood pressure (time frame: 90 days after treatment initiation).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Exenatide in 42 people.
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.
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.