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Efficacy of Exenatide-LAR and Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Type 2 Diabetes
Plain-language guide to NCT02811484: phase 4 randomized trial of Exenatide. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02811484
- Phase
- phase 4
- Status
- withdrawn
- Start
- 2016-06
- Completion (planned or actual)
- 2018-06
- Participants
- n/a (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- 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 see what the effects of using one or two additional diabetes drugs (dapagliflozin and exenatide-LAR) are on blood sugar levels in patients who are taking insulin.
It had three arms (groups): Group 1 (other), Group 2 (placebo comparator) and Group 3 (experimental).
Insulin titration and behavioral therapy.
Exenatide-LAR plus Dapagliflozin placebo, basal insulin titration, and behavioral therapy.
Exenatide-LAR plus Dapagliflozin, basal insulin titration, and behavioral therapy.
The registry classes the interventions as behavioral and drug.
Who Took Part
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diagnosis of Type 2 diabetes. Provided written consent.
The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: history of type 1 diabetes; fasting c-peptide \<.8 ng/ml; AST/ALT greater or equal to 2.5 upper limits of normal.
How the Study Was Run
The set-up was randomized, factorial and double-blind.
The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.
As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2016-06 with completion listed for 2018-06.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in HbA1c (time frame: baseline, 24 weeks).
It also tracked 6 secondary outcomes, for example Change in Body Weight, Change in waist circumference, Change in fasting glucose, Change in fasting lipids and Change in blood pressure.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Exenatide in people.
It was withdrawn before enrolling anyone; 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.