Colesevelam Pediatric Type 2 Diabetes Mellitus Study

Study ID
WEL-307

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact


Principal Investigator

Official Title

Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus

Brief Overview


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]).

Participant Eligibility


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.