Status:
COMPLETED
Colesevelam for Children With Type 2 Diabetes
Lead Sponsor:
Daiichi Sankyo
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
10-17 years
Phase:
PHASE4
Brief 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 Welc...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 24 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2020
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT01258075
Start Date
February 24 2011
End Date
April 21 2020
Last Update
May 13 2021
Active Locations (24)
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1
Tucson, Arizona, United States, 85724
2
Little Rock, Arkansas, United States, 72202
3
Los Angeles, California, United States, 90027
4
Oakland, California, United States, 94609