Glucagon for Diabetes

(SIGNAL Trial)

AS
Overseen ByAlyssa Sudnick, MS

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?

DD

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

My blood sugar and HbA1c levels are within the normal range.
I am a healthy adult between 18 and 45 years old.
My BMI is less than 27.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment - Set 1

Participants complete two 5-hour hyperinsulinemic clamp procedures to examine the effects of glucagon on glucose metabolism.

5-12 weeks
2 visits (in-person)

Treatment - Set 2

Participants complete two 5-hour hyperinsulinemic clamp procedures to examine the effects of insulin on glucose metabolism.

5-12 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Glucagon infusion during hyperinsulinemic clampExperimental Treatment1 Intervention
Group II: Saline infusion during hyperinsulinemic clampPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+