Colesevelam for Children With Type 2 Diabetes

• Status: Completed
• Trial end date: 2020-04-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Colesevelam Hydrochloride; Metformin

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