Type 1 DiabetesPhase 2NCT06976619

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

A Phase 2 study testing Liraglutide Pen Injector and Saline Injections in people with Type 1 Diabetes and Type 2 Diabetes, run by Mayo Clinic at 1 site in United States.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 25 to 70 years
Conditions the study is for: Type 1 Diabetes, Type 2 Diabetes
What is being tested?: Liraglutide Pen Injector and Saline Injections
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 3 Oct 2025to 31 Mar 2029
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 1 or type 2 diabetes treated with insulin

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Adrian Vella, MD contact

507-255-6515

vella.adrian@mayo.edu

United States1 site, 1 recruiting

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Amy O'Byrne, 507-255-8547, OByrne.Amy14@mayo.edu
Adrian Vella
Recruiting

Other trials in United States

About this study

Official title: The Effect of Glycemic Control and of GLP-1 Receptor Agonism on Islet GLP-1 in People

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.

Read the detailed description

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. This supports other evidence (rodents and humans) that through the (inducible) expression of a prohormone convertase (PC-1/3), the α-cell can process proglucagon to intact GLP-15,6. 'Islet' or 'pancreatic' GLP-1 acts in a paracrine fashion to regulate insulin (basal and 1st phase) and glucagon secretion. 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.

There is evidence that α-cell proglucagon processing is subject to paracrine regulation by the β-cell. β-cell secretion of the signaling peptide 14-3-3-Zeta is decreased by GLP1R agonism (Fig.1), stimulating α-cell production of GLP-1. This is a testable hypothesis in humans; people with type 1 diabetes (T1DM) have dysregulated glucagon secretion and evidence of islet GLP-1. It is unclear if the effects of GLP1R agonism on islet GLP-1 differ 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
Being tested: Liraglutide Pen Injector, Saline Injections
Keywords: Islet Function, Glucose Toxicity
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Liraglutide Pen InjectorDrug
Also called Liraglutide
Liraglutide 0.6mg
Saline InjectionsOther
Also called Placebo
Saline in syringes to serve as placebo for single blind study

Study groups in NCT06976619
Study group	Role	What they receive
Type 1 diabetes - Placebo arm	Placebo comparator	Subjects will receive syringes loaded with saline to self-administer daily during the intervention phase Receives: Other: Saline Injections
Type 1 diabetes - Liraglutide arm	Active comparator	Subjects will receive 0.6mg Liraglutide syringes to self-administer daily during the intervention phase Receives: Drug: Liraglutide Pen Injector
Type 2 diabetes - Placebo arm	Placebo comparator	Subjects will receive syringes loaded with saline to self-administer daily during the intervention phase Receives: Other: Saline Injections
Type 2 diabetes - Liraglutide arm	Active comparator	Subjects will receive 0.6mg Liraglutide syringes to self-administer daily during the intervention phase Receives: Drug: Liraglutide Pen Injector

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of exendin 9-39 on fasting glucagon secretion rate before and after liraglutide treatment
Glucagon secretion rate will be estimated by deconvolution from glucagon concentrations during fasting (-30 to 0 min) of each study day.
Measured: 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
Glucagon secretion rate will be estimated by deconvolution from glucagon concentrations during hyperglycemia (150 to 180 min) of each study day.
Measured: 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)

Secondary outcomes (2)

Effect of exendin 9-39 on fasting glucagon secretion rate in people with type 1 diabetes vs type 2 diabetes
Glucagon secretion rate will be estimated by deconvolution from glucagon concentrations during fasting (-30 to 0 minutes) during the baseline studies
Measured: The change in fasting glucagon secretion (saline vs. exendin 9-39) in the baseline studies will be compared in people with type 1 diabetes vs type 2 diabetes
Effect of exendin 9-39 on glucagon secretion rate during hyperglycemia in people with type 1 diabetes vs type 2 diabetes
Glucagon secretion rate will be estimated by deconvolution from glucagon concentrations during hyperglycemia (150 to 180 minutes) during the baseline studies
Measured: The change in glucagon secretion during hyperglycemia (saline vs. exendin 9-39) in the baseline studies will be compared in people with type 1 diabetes vs type 2 diabetes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 202531 Mar 2029

First posted16 May 2025
Study start3 Oct 2025
Primary completion30 Oct 2028 (estimated)
Study completion31 Mar 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06976619
Sponsor's protocol ID: 24-007682
Status last verified: Oct 2026
First submitted: 5 May 2025
Last updated: 19 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Adrian Vella, MD

507-255-6515

vella.adrian@mayo.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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