Phase 3
N=11
A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04459338 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Insulin Secretion Rate During Exendin-9,39 Infusion vs. Insulin Secretion Rate During Saline Infusion — 191; 171 nmol/min per 300 min — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Exendin-9,39 (Biological); Saline (Other)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Adrian Vella
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Secretion Rate During Exendin-9,39 Infusion vs. Insulin Secretion Rate During Saline Infusion |
191; 171 | 0.02 sig |
Summary
The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in the control of blood sugar level by enhancing insulin secretion from the pancreas after eating a meal. The purpose of this research study is to evaluate the role of GLP1R in the response to elevated glucagon concentrations.
Eligibility Criteria
Inclusion Criteria
- 20 weight-stable, non-diabetic subjects
Exclusion Criteria
- Age 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
- HbA1c ≥5.9%
- Use of glucose-lowering agents.
- For female subjects: positive pregnancy test at the time of enrollment or study
- History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
- Active systemic illness or malignancy.
- Symptomatic macrovascular or microvascular disease.
Data sourced from ClinicalTrials.gov (NCT04459338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.