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GLP-1 Receptor Agonist

Dulaglutide + Exercise for Type 1 Diabetes (KML002 Trial)

Phase 2

Recruiting

Led By Kaitlin Love, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-40 years

Using insulin for diabetes treatment only (multiple daily injections or insulin pump with or without sensor augmentation)

Must not have

Diabetic ketoacidosis (DKA) on presentation to screening visits or study admission days

History of microvascular (microalbuminuria, retinopathy, neuropathy) or macrovascular diabetes complications (coronary artery disease, stroke, peripheral vascular disease) as well as clinically significant cardiac arrhythmias or conduction disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and after 14 weeks of treatment. measured before and after insulin clamp.

Summary

This trial will test if a medication and exercise can improve blood flow in people with type 1 diabetes by reducing oxidative stress.

Who is the study for?

Adults aged 18-40 with type 1 diabetes for over 5 years, managing it with insulin only, and a stable health condition can join. They must have an HbA1c level below 8.5% and a BMI between 19-34.9 kg/m^2. Those who've smoked recently, have musculoskeletal issues preventing exercise, severe diabetes complications or other unstable diseases cannot participate.

What is being tested?

The trial is testing if Dulaglutide (a medication) and regular exercise improve blood flow in muscles by reducing stress on blood vessels in adults with type 1 diabetes. Participants will either receive Dulaglutide or a placebo while following an exercise routine to see which combination works best.

What are the potential side effects?

Dulaglutide may cause digestive problems like nausea or vomiting, possible allergic reactions, and rarely thyroid tumors. Exercise might lead to muscle soreness or injury if not done properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 40 years old.

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I use insulin for my diabetes, either through injections or a pump.

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My non-diabetes medications have not changed in the last 6 months.

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I have had type 1 diabetes for more than 5 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had diabetic ketoacidosis during screening or study admission.

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I have diabetes with complications like heart disease, stroke, or nerve damage.

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I was hospitalized for diabetic ketoacidosis within the last year.

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I have a condition that stops me from doing exercise tests or training.

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I do not have any acute or unstable conditions except for Type 1 Diabetes.

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I am taking medication for blood pressure or heart conditions.

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I have a history of severe stomach or pancreas issues, or thyroid cancer in my family.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and after 14 weeks of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and after 14 weeks of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and after 14 weeks of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Microvascular blood volume (MBV)

Secondary study objectives

Brachial artery flow mediated dilation (FMD)

Cardiorespiratory fitness, maximum consumption of oxygen (VO2max)

Glucose infusion rate (GIR)

+1 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Exercise trainingActive Control1 Intervention

Supervised high intensity interval training on a stationary bicycle will be conducted 3 days per week for 14 weeks. Participants will warm up at low intensity for 3 min then repeat 1-min bouts of 100% peak power output followed by 1-min recovery at 50 W. Training will start with 6 intervals per session, increasing by 2 intervals every 2 weeks. Sessions will end with a 10-min cool-down.

Group II: DulaglutideActive Control1 Intervention

Dulaglutide (0.75 mg/0.5 mL weekly for 2 weeks, then 1.5 mg/0.5 mL weekly for 12 weeks) subcutaneous injection

Group III: PlaceboPlacebo Group1 Intervention

Saline subcutaneous injection, volume matched to dulaglutide, i.e. 0.5 mL weekly for 14 weeks

0 / 11Eligibility criteria met