Recruiting
Phase 2

GLP1R Agonist

Sponsor:

Mayo Clinic

Code:

NCT06976619

Conditions

Type 1 Diabetes

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Not accepted

Interventions

Liraglutide Pen Injector

Saline Injections

Study Details

Brief summary:

The investigators recently demonstrated that blockade of Glucagon-Like Peptide-1's (GLP-1) receptor (GLP1R) results in changes in islet function without changes in circulating GLP-1. These effects are more pronounced in people with early type 2 diabetes (T2DM) in keeping with increased expression of PC-1/3 and GLP-1 that is observed in diabetic islets. However, its regulation is at present unknown. There is evidence that α-cell proglucagon processing is subject to paracrine regulation by the β-cell3. It is unclear if the effects of GLP1R agonism on islet GLP-1 differ in Type 1 diabetes (T1DM) compared to T2DM. This experiment will examine the effect of glycemic control ± a GLP1R agonist on islet GLP-1 in people with (T2DM) and without (T1DM) β-cells.

Conditions

Type 1 Diabetes

Type 2 Diabetes

Study ID

NCT06976619

Start date

Oct 3, 2025

Status verified date

Oct, 2025

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Oct 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Type 1 or type 2 diabetes treated with insulin

Exclusion Criteria:

1. Age < 25 or > 70 years.
2. HbA1c > 10.0%
3. For female subjects: positive pregnancy test at the time of enrollment or study
4. History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
5. Prior use of GLP-1 receptor agonists in the previous year.
6. Active systemic illness or malignancy.
7. Symptomatic macrovascular or microvascular disease.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Type 1 diabetes - Placebo arm

Subjects will receive syringes loaded with saline to self-administer daily during the intervention phase

active comparator: Type 1 diabetes - Liraglutide arm

Subjects will receive 0.6mg Liraglutide syringes to self-administer daily during the intervention phase

placebo comparator: Type 2 diabetes - Placebo arm

Subjects will receive syringes loaded with saline to self-administer daily during the intervention phase

active comparator: Type 2 diabetes - Liraglutide arm

Subjects will receive 0.6mg Liraglutide syringes to self-administer daily during the intervention phase

Interventions

Liraglutide Pen Injector

Liraglutide 0.6mg

Saline Injections

Saline in syringes to serve as placebo for single blind study

Primary outcome measure

  • Effect of exendin 9-39 on fasting glucagon secretion rate before and after liraglutide treatment [ Time Frame: The change in fasting glucagon secretion rate (saline vs. exendin 9-39) in the baseline study will be compared with the change in fasting glucagon secretion rate (saline vs. exendin 9-39) after 30 days of treatment with liraglutide (post-liraglutide) ]
  • Effect of exendin 9-39 on glucagon secretion rate during hyperglycemia before and after liraglutide [ Time Frame: The change in glucagon secretion rate during hyperglycemia (saline vs. exendin 9-39) in the baseline study will be compared with the change (saline vs. exendin 9-39) after 30 days of treatment with liraglutide (post-liraglutide) ]

Central Contacts and Locations

Central contacts

Adrian Vella, MD

507-255-6515vella.adrian@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amy O'Byrne

507-255-8547OByrne.Amy14@mayo.edu

Principal Investigator:

Adrian Vella

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

  • Islet Function
  • Glucose Toxicity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.