Dulaglutide + Exercise for Type 1 Diabetes
(KML002 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain blood pressure medications (like calcium channel blockers or ACE inhibitors).
What data supports the effectiveness of the drug Dulaglutide (Trulicity) for Type 1 Diabetes?
Dulaglutide (Trulicity) is effective in managing type 2 diabetes by lowering blood sugar levels and reducing body weight, and it has shown benefits in reducing the risk of major heart-related events in patients with type 2 diabetes. While this data is specific to type 2 diabetes, it suggests potential benefits for blood sugar control and heart health that might be relevant for type 1 diabetes when combined with exercise.12345
Is the combination of Dulaglutide and exercise safe for people with type 1 diabetes?
How is the drug Dulaglutide unique for treating type 1 diabetes?
Dulaglutide is unique for type 1 diabetes as it is typically used for type 2 diabetes and works by mimicking a hormone that helps control blood sugar levels, which is different from the usual insulin-based treatments for type 1 diabetes. Combining it with exercise may offer a novel approach to managing blood sugar levels in type 1 diabetes patients.611121314
What is the purpose of this trial?
The investigators will test the hypothesis that, in adults with type 1 diabetes (T1D), glucagon-like peptide-1 receptor agonism (GLP-1RA, i.e. dulaglutide) and exercise training each enhance insulin-mediated skeletal muscle microvascular perfusion via attenuating endothelial oxidative stress and thereby improving endothelial function.
Research Team
Kaitlin Love, MD
Principal Investigator
Associate Professor - Endocrinology
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to 14 weeks of either dulaglutide, placebo, or exercise training
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dulaglutide
- Exercise Training
Dulaglutide is already approved in United States, European Union for the following indications:
- Type 2 diabetes mellitus
- Cardiovascular risk reduction in adults with established cardiovascular disease or multiple cardiovascular risk factors
- Type 2 diabetes mellitus
- Cardiovascular risk reduction in adults with established cardiovascular disease or multiple cardiovascular risk factors
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor