A Phase 3, Open-Label, Multicenter, Single-Arm Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Dulaglutide 3.0 Mg and 4.5 Mg in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus
Study of Investigational Medication for Type 2 Diabetes in Youth
Tamara Hannon, MD
Primary Investigator
Brief description of study
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of dulaglutide 3.0 mg and 4.5 mg in pediatric participants 10 to less than 18 years of age with T2DM.
Detailed description of study
Study details include:
The study duration will be up to 34 weeks including the screening, treatment, and safety follow-up period.
The treatment duration will be up to 26 weeks.
The clinic visits will be
o every 2 weeks – Visit 1 to Visit 3
o every 4 weeks – Visit 3 to Visit 10
o 6 weeks – Visit 10 to Visit 12
o 4 weeks – Visit 12 (or date of early discontinuation) to Visit 801
Telephone visits will be performed between clinic visits at Visit 6, Visit 8, and Visit 11
Participation in this study will last about 8 months.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Type 2 Diabetes, T2D
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Age: 10 years - 17 years
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Gender: All
Inclusion Criteria:
- Have Type 2 diabetes treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to screening.
- Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of >85th percentile
Exclusion Criteria:
- Have Type 1 diabetes
- Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening
- After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
- Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
- Have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease
- Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening
This study investigates the safety and effects of an investigational medication in children and teenagers aged 10 to less than 18 years who have Type 2 Diabetes Mellitus (T2DM). Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels. The study aims to understand how the investigational medication works and how it is tolerated by participants.
Participants in this study will receive the investigational medication and will have regular check-ups at the clinic. The study includes both in-person visits and phone calls to monitor the participants' health and gather information on how the medication is working. This helps ensure the safety and effectiveness of the treatment.
- Who can participate: Children and teenagers aged 10 to less than 18 years with Type 2 diabetes can participate. They must be treated with diet, exercise, and metformin and/or basal insulin with stable doses for at least 8 weeks. Participants must weigh at least 50 kg and have a BMI over the 85th percentile.
- Study details: Participants will take the investigational medication and attend clinic visits for check-ups. They will also have phone calls between some visits to check their progress. This helps researchers learn more about the medication's safety and effects.
- Study timelines: The study will last 34 weeks.
Interested in the study?
This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.
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