drugset / Trial / NCT01258075

Colesevelam for Children With Type 2 Diabetes

NCT01258075

Phase 4 Completed 236 enrolled Daiichi Sankyo
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2011-02-24
Primary completion
2019-11-01
Completion
2020-04-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Colesevelam Other / unclassified 0.625 g Oral
Subject Colesevelam Other / unclassified 3.75 g Oral