Type 2 diabetes

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

Recruiting · Rochester, Minnesota

✓ Study treatment at no cost✓ PHASE2

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Study care at no cost to you

For your time and travel

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Most need no insurance or papers

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Your choice

Voluntary — you can stop anytime

What is this study?

It is , overseen by an independent and licensed medical staff.

Read the full clinical 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. 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.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

•Adults with either type 1 or type 2 diabetes who are treated with insulin
•People who are between 25 and 70 years old (age limits apply)
•People whose HbA1c is 10.0% or lower
•People who are not pregnant at the time of study start (for females)
•People who did not use GLP-1 receptor agonist medicine in the previous year

🚫 You may not be able to join if…

•People younger than 25 or older than 70
•People with HbA1c higher than 10.0%
•Female participants with a positive pregnancy test at enrollment
•People with a history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty, or vagotomy
•People who used GLP-1 receptor agonists in the previous year

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

✓Adults age 25 to 70
✓Type 2 diabetes treated with insulin
✓HbA1c at or below 10.0%
✓No GLP-1 receptor agonist use in the prior year
✓Not pregnant (for females)
✓No history of certain upper abdominal surgeries or active serious illness

!Not for people who are pregnant or breastfeeding
!May require a break from current GLP-1 medications

How this study is designed

The real details, in plain words. Tap the underlined words to learn what they mean.

•Some participants receive a . The study team tells you your chances of getting the active treatment before you decide.
•You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
•This study is , so results can't be swayed by expectations. Your medical team always knows what you're getting.
•There are 4 groups in this study.

What to expect, step by step

· This study lasts about 4 weeks

1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
2
Treatment
About 4 weeks
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

What's being tested

Drug: Liraglutide Pen Injector
Other: Saline Injections

Has this treatment been tested before?

Yes. This treatment has already been through earlier human studies for safety before reaching this stage.

Who's running this study?

Sponsor

Mayo Clinic

Overseen by Adrian Vella, MD

Every study is also reviewed by an independent that protects participants.

What you need to know before you apply

What is this study testing?+

Is it safe? Who makes sure of that?+

This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

I take a GLP-1 medication (like Ozempic or Wegovy). Can I still join?+

Maybe. This study may ask you to pause certain weight or diabetes medications for a period of time (a 'washout') before joining, or it may be looking for people not currently on them. The coordinator will review your medications with you — don't stop any medication on your own.

Does it cost anything? Will I be paid?+

The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT06976619 · Locations: Minnesota