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Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure
Plain-language guide to NCT00766857: phase 4 randomized trial of Exenatide and Insulin Glargine, 27 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00766857
- Phase
- phase 4
- Status
- completed
- Start
- 2009-05
- Completion (planned or actual)
- 2012-12
- Participants
- 27 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus; Congestive Heart Failure
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Exenatide and Insulin Glargine.
It had two arms (groups): 1. Exenatide (experimental) and 2. Insulin glargine (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 27 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Type 2 diabetes mellitus. Male and postmenopausal female. Age 18 years an above. Confirmed congestive heart failure (NHYA functional class II-IV). Patients should receive a stable standard therapy for their cardiac condition for 3 months prior entering the study.
The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: type 1 diabetes mellitus; serious renal or liver impairment; (Receiving treatment for) malignant disease.
How the Study Was Run
Design: randomized, parallel-group and open-label.
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.
Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.
It started in 2009-05 with completion listed for 2012-12.
It ran at 1 site in Netherlands.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction) (time frame: week -2 and week 11).
It also tracked 4 secondary outcomes, for example Cardiac function, dimensions and scarring will be measured bij CMR and Exercise capacity and performance will be assessed by a 6-minute walking test.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Exenatide and Insulin Glargine in 27 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Exenatide compound page and the Insulin Glargine compound page, all human trials.
Our Notes on the Compounds
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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.