CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 236 enrolled
Drug / intervention
High-dose colesevelam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01258075
NCT01258075Phase 4Completed
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Colesevelam Oral Suspension as Monotherapy or Add-on to Metformin Therapy in Pediatric Subjects With Type 2 Diabetes Mellitus

Daiichi Sankyo·interventional·Posted Dec 10, 2010·Updated May 13, 2021

In Brief

A Phase 4 clinical trial evaluating High-dose colesevelam and Low-dose colesevelam for Type 2 Diabetes Mellitus. Completed, enrolled 236 participants across 24 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2010
Enrollment StartFeb 24, 2011
Primary CompletionNov 1, 2019
Study CompletionApr 21, 2020
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 15.6 years ago

Interventions

High-dose colesevelamdrug

3.75 grams colesevelam hydrochloride in oral suspension

Low-dose colesevelamdrug

0.625 grams colesevelam hydrochloride in oral suspension