60 Participants Needed

Liraglutide for Diabetes

AV
Overseen ByAdrian Vella, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Mayo Clinic
Must be taking: Insulin
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Research Team

AV

Adrian Vella, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals with Type 1 or Type 2 Diabetes who are interested in how different treatments affect their insulin-producing cells. Specific eligibility criteria were not provided, so participants should inquire about detailed requirements.

Inclusion Criteria

I have diabetes and am treated with insulin.

Exclusion Criteria

I am younger than 25 or older than 70.
HbA1c > 10.0%
I am not pregnant at the time of joining the study.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or 0.6mg Liraglutide daily for 30 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Liraglutide
Trial Overview The study tests the effects of a GLP-1 receptor agonist (Liraglutide Pen Injector) versus saline injections on the function of insulin-producing cells in diabetic patients. It aims to understand if and how these treatments alter islet GLP-1 levels differently in Type 1 and Type 2 Diabetes.
Participant Groups
4Treatment groups
Active Control
Placebo Group
Group I: Type 1 diabetes - Liraglutide armActive Control1 Intervention
Subjects will receive 0.6mg Liraglutide syringes to self-administer daily during the intervention phase
Group II: Type 2 diabetes - Liraglutide armActive Control1 Intervention
Subjects will receive 0.6mg Liraglutide syringes to self-administer daily during the intervention phase
Group III: Type 1 diabetes - Placebo armPlacebo Group1 Intervention
Subjects will receive syringes loaded with saline to self-administer daily during the intervention phase
Group IV: Type 2 diabetes - Placebo armPlacebo Group1 Intervention
Subjects will receive syringes loaded with saline to self-administer daily during the intervention phase

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

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