Glucagon for Diabetes
(SIGNAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study examines how glucagon works to regulate glucose metabolism, based on new findings that suggest glucagon signaling in the liver has more than one role, and that these multiple roles can be opposing in nature. Understanding this biology provides an opportunity to develop new generations of glucagon-based drugs that target specific pathways, making them more effective at controlling blood glucose.
Participants will complete paired, 5-hour hyperinsulinemic glucose clamp visits in which they receive either glucagon or saline infusions while blood glucose is maintained and frequent blood samples are collected. The primary focus is whether coordinated glucagon and insulin signaling enhances hepatic insulin sensitivity.
Who Is on the Research Team?
David D'Alessio, MD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-45 with a BMI under 27.0 kg/m² and normal blood sugar levels (fasting plasma glucose ≤ 95 mg/dL or HbA1c ≤ 5.8%). It's not suitable for those outside this age range, overweight individuals, or anyone with higher fasting glucose or HbA1c levels.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Set 1
Participants complete two 5-hour hyperinsulinemic clamp procedures to examine the effects of glucagon on glucose metabolism.
Treatment - Set 2
Participants complete two 5-hour hyperinsulinemic clamp procedures to examine the effects of insulin on glucose metabolism.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Glucagon
Trial Overview
The study is testing how glucagon affects glucose metabolism in the liver by comparing its effects to saline (a placebo). Participants will undergo two sessions where their blood sugar is controlled while they receive either glucagon or saline infusions and have frequent blood samples taken.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Glucagon infusion either graded (0.2→0.4→0.6 ng/kg/min) or continuous (0.4 ng/kg/min) during the final 90 minutes of a hyperinsulinemic glucose clamp. The graded or continuous glucagon infusions are given as a component of 2 separate protocols.
Saline infusion during the final 90 minutes of an otherwise identical clamp procedure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
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