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Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes
Plain-language guide to NCT01855490: phase 1 interventional trial of Exenatide, 17 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01855490
- Phase
- phase 1
- Status
- completed
- Start
- 2012-01
- Completion (planned or actual)
- 2013-07
- Participants
- 17 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 1 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Exenatide.
The investigators will also test the effects of Exenatide on gastric emptying during the MMTT.
It had 1 arm (groups): Single-arm treatment with Exenatide (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 17 actual participants took part.
It was open to people of any sex aged from 18 years up to 56 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: T1D of at least 3 yrs duration. Male or female aged 18-56 years who meets the American Diabetes Association standard T1DM criteria. Absence of severe hypoglycemia in the past 6 months. Absence of ketoacidosis in the past 6 months. Menstruating women must have a negative pregnancy test and be willing to avoid pregnancy during the study period.
The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: inability or unwillingness to give informed consent; prior exenatide or liraglutide treatment or use of any medication that could potentially affect diabetes or immunologic status; known hypersensitivity to exenatide or any product components.
How the Study Was Run
It was run as a single-group and open-label study.
Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2012-01 with completion listed for 2013-07.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Effect of exenatide on metabolic responses to an oral (as a mixed meal) or intravenous glucose challenge in subjects with established T1D with or without residual insulin production (time frame: Each patients is estimated to finish the study within 4-6 weeks).
What This Means in Plain Language
Put simply, this is a phase 1 trial of Exenatide in 17 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, 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.