The Effect of Glycemic Control and of GLP-1 Receptor Agonism on Islet GLP-1 in People With Type 1 and Type 2 Diabetes

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06976619
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide Pen Injector — DRUG
    Liraglutide 0.6mg
  • Saline Injections — OTHER
    Saline in syringes to serve as placebo for single blind study

Study Details

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.

Key Dates

Start date
Oct 3, 2025
Status verified
Oct 2025
Primary completion
Oct 30, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Amy O'Byrne
[email protected]
507-255-8547
Adrian Vella (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Type 1 diabetesType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Mayo Clinic in Rochester· Rochester, MN

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