Colesevelam for Children With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: High-dose colesevelam; Low-dose colesevelam
Intervention description: 3.75 grams colesevelam hydrochloride in oral suspension; 0.625 grams colesevelam hydrochloride in oral suspension
Intervention MeSH terms: Colesevelam Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 236.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; Blood glucose; Anti-diabetic; Bile acid sequestrant; Colesevelam HCl; Oral suspension; Pediatric; Add-on therapy; Add-on to metformin; Metformin; Adolescent; Lipid

Summary:

      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.
    

Eligibility criteria:

        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