Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus
This study will see if the study drug will be a good treatment for type 2 diabetes in children 10 to 17 years old. The groups will be low-dose and high-dose. 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.
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]).
10 Years to 17 Years
Accepting Healthy Volunteers?
- 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.
- 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