Glucagon for Diabetes
(SIGNAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how glucagon, a hormone, affects blood sugar levels in people without diabetes. Researchers aim to determine if glucagon can improve the liver's response to insulin, potentially aiding in the development of better blood sugar management treatments. Participants will receive either glucagon or a harmless saline (saltwater) solution to compare effects. Ideal candidates for this trial are healthy adults without a personal or family history of diabetes and who are not taking medications that affect blood sugar. As a Phase 1 trial, this research focuses on understanding glucagon's effects in people, offering participants the opportunity to be among the first to receive this treatment.
Will I have to stop taking my current medications?
If you are taking daily medications that affect blood sugar or digestion, like glucocorticoids or psychotropics, you will need to stop them to participate in this trial.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that glucagon treatments, such as dasiglucagon, are generally safe. One study found that even small doses of dasiglucagon effectively increased blood sugar levels in individuals with low blood sugar, without causing serious side effects. Another study on a similar glucagon treatment demonstrated faster recovery from low blood sugar compared to a placebo, with no major safety issues identified.
This trial is in the early stages and is designed to carefully monitor any side effects. Early trials usually involve fewer participants, but they help researchers assess a treatment's safety. Since glucagon is already used for other conditions, it suggests likely safety for this trial. Overall, research so far indicates that glucagon treatments are safe.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the glucagon infusion treatment for diabetes because it offers a new way to help manage blood sugar levels. Traditional diabetes treatments often focus on insulin or medications that increase insulin sensitivity. However, glucagon works differently by increasing blood sugar levels when they drop too low, which can be especially useful during insulin therapy. This treatment is being explored not just for its potential to counteract hypoglycemia, but also for its ability to provide a more balanced approach to blood sugar management, potentially improving overall glucose control in patients with diabetes.
What evidence suggests that glucagon might be an effective treatment for diabetes?
Research has shown that glucagon plays a crucial role in controlling blood sugar levels. In this trial, participants will receive either a glucagon infusion or a saline infusion during a hyperinsulinemic clamp procedure. Studies have found that glucagon administration can significantly raise blood sugar levels, reaching about 138.6 mg/dL. This suggests glucagon might be helpful when blood sugar is too low. Additionally, glucagon works with insulin, which is essential for maintaining balanced blood sugar levels. Understanding the interaction between glucagon and insulin could lead to better diabetes treatments by improving how the liver manages sugar. These findings suggest that glucagon could be useful in new ways to manage diabetes.46789
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
Citations
High Doses of Exogenous Glucagon Stimulate Insulin ...
Glucagon infusion increased blood glucose linearly and achieved a maximum concentration of 138.6 ± 6.6 mg/dL (range 106–164 mg/dL), for an average concentration ...
Mathematical Models of the Effect of Glucagon on Glycemia in ...
We here investigated the roles of insulin and glucagon in the regulation of glycemia in individuals treated with an SGLT2 inhibitor using mathematical model ...
Dasiglucagon, a next‐generation glucagon analogue, for ...
Median (95% CI) observed time to recovery was 10.0 (8.0; 12.0) minutes for dasiglucagon and 35.0 (20.0; −) minutes for placebo (P < .001).
A glucose-insulin-glucagon coupled model of the ...
Significant impairment in glucose dependent glucagon suppression was observed in patients with T2D (duration of T2D: 8 (6–36) months) relative to weight matched ...
Studies of Insulin and Glucagon Action in the Liver (SIGNAL)
Set 1: Each participant will complete two 5-hour hyperinsulinemic clamp procedures to examine the effects of glucagon on glucose metabolism ...
Glucagon-like peptide-1 receptor agonists and type ...
Clinical and safety outcomes with GLP-1 receptor agonists and SGLT2 inhibitors in type 1 diabetes: A real-world study. J Clin Endocrinol ...
7.
diabetesjournals.org
diabetesjournals.org/care/article/41/3/531/36652/Pharmacokinetic-and-PharmacodynamicPharmacokinetic and Pharmacodynamic Characteristics of ...
Our results confirm that even these low doses of dasiglucagon (100 or 300 µg) efficiently raise PG concentrations from hypoglycemia, making it ...
The Effect of the Interaction of Glucagon and Insulin on ...
Clamp study with insulin infused at 0.4 mU/Kg/min, followed by a 2 week withdrawal period followed by a clamp study with insulin infused at 0.8 mU/Kg/min · Other ...
Cardiovascular safety and glycemic control of glucagon ...
For glycemic control, the effect of any GLP-1 was better than placebo, but no difference was found between GLP-1s. We also found that liraglutide was the only ...
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