Colesevelam for Children With Type 2 Diabetes
Purpose
This study will evaluate the efficacy and safety of the study drug in treating type 2 diabetes in children 10 to 17 years old. The groups will be low-dose (0.625 g Welchol) and high-dose (3.75 g Welchol). The children will have a 2 in 5 chance of being assigned to the low-dose group. They will have a 3 in 5 chance of being assigned to the high-dose group. We believe the study drug will be safe, well tolerated, and improve blood sugar control in children 10 to 17 years old.
Condition
- Type 2 Diabetes Mellitus
Eligibility
- Eligible Ages
- Between 10 Years and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of type 2 diabetes mellitus, as defined by the American Diabetes Association; - Written informed consent of study participation - Males and females aged 10 to 17 years, inclusive, at randomization (randomization must occur before 18th birthday); - HbA1c at screening between 7.0% and 10.0%, inclusive; - Fasting C-peptide >0.6 ng/mL; and - Anti-diabetic treatment at screening: - Treatment-naïve or untreated; OR - On metformin monotherapy: Metformin monotherapy has been initiated prior to screening.
Exclusion Criteria
- Fasting plasma glucose >270 mg/dL; - Diagnosis of type 1 diabetes; - History of more than one episode of ketoacidosis after the initial diagnosis of type 2 diabetes mellitus; - Clinical laboratory assessments/evaluations, eg. autoimmune markers, aminotransferases, triglycerides, creatinine clearance, and Hb variants, that are not within the protocol-defined parameters - Systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥95 mmHg - Use of medications not allowed by protocol-defined parameters, eg. insulin or any medication that affects insulin sensitivity or secretion, growth hormones/somatotropin, or anabolic steroids - Genetic syndrome or disorder known to affect glucose - Participation in a weight loss program or another interventional research study within 60 days; - Female participants who are lactating, pregnant, or plan to become pregnant within 1 year of screening; - Female participants who are sexually active and unwilling to use appropriate contraception for the duration of the study; - History of bowel obstruction; - Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the Investigator, would prevent full participation
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Colesevelam |
High-dose colesevelam suspended in a drink for oral administration once daily with dinner |
|
|
Experimental Placebo proxy |
Low-dose colesevelam suspended in a drink for oral administration once daily with dinner |
|
More Details
- Status
- Completed
- Sponsor
- Daiichi Sankyo
Study Contact
Detailed Description
Colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (T2DM) to evaluate clinical safety and efficacy in patients aged 10-17 years. The patients may have been treated with Metformin or have had no antidiabetic drug treatment in the previous three months. Study Hypothesis: Colesevelam oral suspension for pediatric subjects with T2DM is safe, well tolerated, and shows improved blood sugar control (as evidenced by a significant change from baseline in hemoglobin A1C [HbA1c]).