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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and after 14 weeks of treatment. measured before and after insulin clamp.
Awards & highlights
KML002 Trial 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.Check my eligibility
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.See study design
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.
KML002 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
KML002 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Microvascular blood volume (MBV)
Secondary outcome measures
Brachial artery flow mediated dilation (FMD)
Cardiorespiratory fitness, maximum consumption of oxygen (VO2max)
Glucose infusion rate (GIR)
+1 moreKML002 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
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Who is running the clinical trial?
University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,245,009 Total Patients Enrolled
Kaitlin Love, MDPrincipal InvestigatorAssociate Professor - Endocrinology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your C-peptide level is less than 0.6 ng/ml.Your oxygen level is below 90% during screening.I am between 18 and 40 years old.You are allergic to perflutren, which is in the Definity© contrast.I have diabetes with complications like heart disease, stroke, or nerve damage.Your body mass index (BMI) is between 19 and 34.9.I use insulin for my diabetes, either through injections or a pump.I was hospitalized for diabetic ketoacidosis within the last year.I have a condition that stops me from doing exercise tests or training.My non-diabetes medications have not changed in the last 6 months.You have low levels of red blood cells (hemoglobin) if you are a woman or a man, high levels of a type of white blood cells (eosinophils), or a low total white blood cell count.I have not had diabetic ketoacidosis during screening or study admission.You have trouble recognizing when your blood sugar gets too low.I do not have any acute or unstable conditions except for Type 1 Diabetes.I have had type 1 diabetes for more than 5 years.I am taking medication for blood pressure or heart conditions.You have smoked within the last 6 months.Your screening tests show normal results or nothing that would affect your health.Your HbA1c level is less than 8.5%.I have a history of severe stomach or pancreas issues, or thyroid cancer in my family.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise training
- Group 2: Placebo
- Group 3: Dulaglutide
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I satisfy the criteria to be included in this examination?
"Participants of this medical trial must possess the following characteristics: age between 18 and 40, type 1 diabetes for a minimum of 5 years, HbA1c below 8.5%, body mass index (BMI) in the range 19-27 kg/m2, treatment with insulin only via multiple daily injections or an insulin pump supplemented by sensors, standard test results not clinically significant, C-peptide levels lower than 0.6 ng/ml on average across 6 months preceding screening process , usage of non-diabetic medications that has been stable over past half year and physical activity less than 150 minutes at moderate intensity or 70"
Answered by AI
Does this experiment have open enrollment at the moment?
"According to clinicaltrials.gov, the recruitment period for this medical study ended on October 31st 2022 and is no longer actively seeking participants. However, there are currently 1289 other trials that require patient volunteers at this time."
Answered by AI
Is Dulaglutide officially sanctioned by the U.S. Federal Drug Administration?
"Dulaglutide has been assessed on a scale of 1 to 3, and our team estimates it to be at level 2. This is because this drug is in Phase 2 trials, giving us some insights into its safety but not yet any information about efficacy."
Answered by AI
Is the participant criteria for this trial inclusive of individuals who are older than 35?
"This clinical trial is available to those between 18 and 40 years old. Alternatively, 220 trials are open to minors while 947 studies are limited to elderly patients."
Answered by AI
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