Colesevelam Pediatric Type 2 Diabetes Mellitus Study (WELKid DM)

Inclusion Criteria:

• Diagnosis of type 2 diabetes mellitus, as defined by the American Diabetes Association;
• Understand study procedures and agree to participate by giving written assent and obtaining written consent from a parent or legal guardian at screening;
• 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;
• Positive autoimmune markers;
• Creatinine clearance <70 mL/min;
• Alanine transaminase or aspartate aminotransferase elevation >2.5 X upper limit of normal;
• Participation in another interventional research study protocol in the past 60 days;
• Female subjects who are lactating, pregnant, or plan to become pregnant within 1 year of screening;
• Female subjects 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;
• Triglycerides >500 mg/dL.