Colesevelam for Children With Type 2 Diabetes

Completed · Phase 4 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01258075

Run by

Daiichi Sankyo

People needed

236

Starts

2011-02-24

Expected to finish

2020-04-21

Last updated by the study team

2021-05-13

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Springfield, Massachusetts, United States
• Study site — New York, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Greenville, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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