||Colesevelam Oral Suspension as Monotherapy or Add-on to Metfromin Therapy in Pediatric Subjects with Type 2 Diabetes Mellitus
||Daiichi Sankyo Pharma Development
||Lorraine Levitt Katz, MD
Who can participate?
- Children and adolescents between 10 and 17 years old
- Diagnosed with type 2 diabetes
- Do not require insulin injections
- In good general health
What is this study about?
The purpose of this research study is to see if colesevelam (Welchol®) is an effective treatment to lower Hemoglobin A1c (HbA1c) levels, a measure of blood sugar, in children and adolescents with type 2 diabetes.
What does participation involve?
The study consists of a screening visit, a two-week Lead-in period while first on colesevelam, then a 12-month Treatment period, and a final follow-up visit after 2 weeks.
If you decide that you want to determine if you qualify for this study, you will be scheduled to come to the research clinic at CHOP for a screening visit where you can expect:
- Interviews about your medical history
- Physical examination
- Blood and urine samples collection for testing
Eligible volunteers that consent and assent to participate, as appropriate, will be randomly assigned to receive either high-dose colesevelam or low-dose taken once daily as a powder mixed in a liquid such as water.
What is important to consider about this study?
- Neither you nor the study physician and team will know which dose of colesevelam you have been assigned.
- There is no guarantee that colesevelam will work. In the event your HbA1c is high while on colesevelam treatment, other Type 2 Diabetes-medications (Metformin and insulin) may be prescribed.
- All volunteers will receive intensive diabetes management from expert medical staff while participating in the study.
How long will this study last?
Total clinical trial participation lasts about 58 weeks – depending on when the treatment begins after the screening visit.
Study-related care and supplies are provided at no cost to you. Participants will be compensated for travel and related expenses. In addition, volunteers will be compensated for the completed study visits.
For more information about this study, please visit ClincalTrials.gov.
Please email email@example.com or call: 267-426-7519
CHOP #: 10-007883
Approval Date: 12/16/11
Expiration Date: N/A