Colesevelam for Children With Type 2 Diabetes

  • Interventional
  • Recruiting
  • NCT01258075
Eligibility Details Visit Clinicaltrials.gov

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.

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]).

Gender
All

Age Group
10 Years to 17 Years

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT01258075

IRB#11-0008

Lead SponsorDaiichi Sankyo, Inc.

Lead PhysicianElizabeth Littlejohn

Collaborator(s)N/A

EligibilityAll
10 Years to 17 Years
Recruiting