Colesevelam Pediatric Type 2 Diabetes Mellitus Study

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.