64 Participants Needed

Dulaglutide + Exercise for Type 1 Diabetes

(KML002 Trial)

LH
KL
Overseen ByKaitlin Love, MD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Virginia
Must be taking: Insulin
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

The research highlights that exercise can increase the risk of hypoglycemia (low blood sugar) in people with type 1 diabetes, which is a safety concern to consider. However, there is no specific safety data available for the combination of Dulaglutide and exercise in this context.678910

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

KL

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

Your C-peptide level is less than 0.6 ng/ml.
Your body mass index (BMI) is between 19 and 34.9.
I use insulin for my diabetes, either through injections or a pump.
See 4 more

Exclusion Criteria

Your oxygen level is below 90% during screening.
You are allergic to perflutren, which is in the Definity© contrast.
I have diabetes with complications like heart disease, stroke, or nerve damage.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to 14 weeks of either dulaglutide, placebo, or exercise training

14 weeks
2 visits (in-person) at baseline and 14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Dulaglutide
  • Exercise Training
Trial Overview 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.
Participant Groups
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

Dulaglutide is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Trulicity for:
  • Type 2 diabetes mellitus
  • Cardiovascular risk reduction in adults with established cardiovascular disease or multiple cardiovascular risk factors
🇪🇺
Approved in European Union as Trulicity for:
  • 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

Trials
802
Recruited
1,342,000+

Findings from Research

Dulaglutide (Trulicity) is a once-weekly GLP-1 agonist that has been approved for the treatment of type 2 diabetes, providing a convenient dosing schedule for patients.
As the third GLP-1 agonist available, dulaglutide offers an effective option for managing blood sugar levels in individuals with type 2 diabetes, contributing to improved glycemic control.
Dulaglutide (Trulicity): The Third Once-Weekly GLP-1 Agonist.Smith, LL., Mosley, JF., Parke, C., et al.[2020]
Dulaglutide (Trulicity®) is an effective once-weekly treatment for adults with type 2 diabetes, showing good tolerance and efficacy both as a standalone therapy and in combination with other diabetes medications, even in high-risk patients.
In the REWIND trial, dulaglutide significantly reduced the risk of major adverse cardiac events over a median follow-up of 5.4 years, highlighting its cardiovascular benefits alongside glycemic control.
Dulaglutide: A Review in Type 2 Diabetes.Scott, LJ.[2021]
Dulaglutide (Trulicity®) is an effective once-weekly treatment for type 2 diabetes, showing greater glucose-lowering effects compared to metformin, sitagliptin, exenatide, and insulin glargine in Phase III clinical trials involving various patient backgrounds.
It is considered non-inferior to liraglutide, another GLP-1 receptor agonist, and is currently reimbursed in Belgium for patients who have not achieved adequate control with dual oral therapies.
[Dulaglutide (Trulicity®), a new once-weekly agonist of glucagon-like peptide-1 receptors for type 2 diabetes].Scheen, AJ.[2016]

References

Dulaglutide (Trulicity): The Third Once-Weekly GLP-1 Agonist. [2020]
Dulaglutide: A Review in Type 2 Diabetes. [2021]
[Dulaglutide (Trulicity®), a new once-weekly agonist of glucagon-like peptide-1 receptors for type 2 diabetes]. [2016]
Advances in the treatment of type 2 diabetes: impact of dulaglutide. [2020]
Dulaglutide: A Review in Type 2 Diabetes. [2015]
Extent and prevalence of post-exercise and nocturnal hypoglycemia following peri-exercise bolus insulin adjustments in individuals with type 1 diabetes. [2021]
Effect of Mini-Dose Ready-to-Use Liquid Glucagon on Preventing Exercise-Associated Hypoglycemia in Adults With Type 1 Diabetes. [2023]
Why should people with type 1 diabetes exercise regularly? [2022]
Glucose requirements to maintain euglycemia after moderate-intensity afternoon exercise in adolescents with type 1 diabetes are increased in a biphasic manner. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The effect of midday moderate-intensity exercise on postexercise hypoglycemia risk in individuals with type 1 diabetes. [2013]
11.United Statespubmed.ncbi.nlm.nih.gov
Diabetes mellitus and exercise. [2006]
12.United Statespubmed.ncbi.nlm.nih.gov
Glucose or intermittent high-intensity exercise in glargine/glulisine users with T1DM. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
An on-line support tool to reduce exercise-related hypoglycaemia and improve confidence to exercise in type 1 diabetes. [2022]
[Management of type 1 diabetes (insulin, diet, sport): "Dorchy's recipes"]. [2022]
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