A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion

NCTNCT04459338Other id20-003995Other id5R01DK126206-03

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names Glucagon, does not test it. It appears in the title.

Overview

Status: Completed
Phase: Phase 3
Enrollment: 11 participants (actual)
Sponsor: Adrian Vella · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 4 Mar 2021
Primary completion: 14 Jun 2022
Completion: 14 Jun 2022
First posted: 7 Jul 2020
Last update posted: 9 Jun 2023
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202120222023

Ph 3
A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
NCT04459338
4 Mar 2021 to 14 Jun 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Exendin-9,39Biological
SalineOther

Arms2

Experimental
Saline, Then Exendin-9,39
A week or two after screening, participants were admitted to the CRTU and Saline was infused during a hyperglycemic clamp during which escalating doses of glucagon were infused. After completion of this study participants underwent a washout period of 2 weeks after which they were readmitted to the CRTU and Exendin-9,39 was infused at 300pmol/kg/min was infused during a hyperglycemic clamp during which escalating doses of glucagon were infused.
Experimental
Exendin-9,39, Then Saline
A week or two after screening, participants were admitted to the CRTU and Exendin-9,39 was infused at 300pmol/kg/min during a hyperglycemic clamp during which escalating doses of glucagon were infused. After completion of this study participants underwent a washout period of 2 weeks after which they were readmitted to the CRTU and Saline was infused during a hyperglycemic clamp during which escalating doses of glucagon were infused.

Primary outcomes1

Outcomes the sponsor listed as primary.

Insulin Secretion Rate During Exendin-9,39 Infusion vs. Insulin Secretion Rate During Saline Infusion
Time frame · Area under the curve was quantified at the end of the Saline Study and at the end of the Exendin-9,39 study
Registry description
This is the area under the curve for insulin secretion over the duration of the hyperglycemic clamp (0 to 300 minutes during the study in the Clinical Research Unit).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Area under the curve was quantified at the end of the Saline Study and at the end of the Exendin-9,39 study

Insulin Secretion Rate During Exendin-9,39 Infusion vs. Insulin Secretion Rate During Saline Infusion

Group	Value (nmol/min per 300 min)	Spread
Insulin Secretion During the Saline Study	191	23
Insulin Secretion During the Exendin-9,39 Study	171	19

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
SalineSubjects are admitted to the Clinical research unit the night before the study and the following morning after an overnight fast, at time 0 glucose is infused to raise concentrations to 165mg/dL. At the same time a glucagon infusion commences at 0.4ng/kg/min. At 60 min the infusion increases to 0.6ng/kg/min, at 120 min to 0.8ng/kg/min, at 180 min 1.0 ng/kg/min, and at 240 min 1.2 ng/kg/min. The glucagon infusion ends at 300 min. Saline infusion is started at time 0 and continues for 300 minutes.	0 / 11	0 / 11	2 / 11
Exendin-9,39Subjects are admitted to the Clinical research unit the night before the study and the following morning after an overnight fast, at time 0 glucose is infused to raise concentrations to 165mg/dL. At the same time a glucagon infusion commences at 0.4ng/kg/min. At 60 min the infusion increases to 0.6ng/kg/min, at 120 min to 0.8ng/kg/min, at 180 min 1.0 ng/kg/min, and at 240 min 1.2 ng/kg/min. The glucagon infusion ends at 300 min. Exendin-9,39 infusion is started at time 0 and continues for 300 minutes.	0 / 11	0 / 11	0 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 25 Years up to 65 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 20 weight-stable, non-diabetic subjects Exclusion Criteria: * Age \< 25 or \> 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.

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