CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 562 enrolled
Drug / intervention
Colesevelam +2 moredrug
Likely dose
Colesevelam 625 mgfrom 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/NCT00789750
NCT00789750Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of WELCHOL as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus (T2DM)

Daiichi Sankyo·interventional·Posted Nov 13, 2008·Updated Jun 26, 2017

In Brief

A Phase 3 clinical trial evaluating Colesevelam, Placebo, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 562 participants across 141 sites.

Detailed Summary

The current study investigates colesevelam as add-on therapy to pioglitazone to improve glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with pioglitazone monotherapy or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy for type 2 diabetes mellitus will be safe, well tolerated, and efficacious.

Study Details

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

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 13, 2008
Enrollment StartApr 1, 2009
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.6 years ago

Interventions

Colesevelamdrug

Colesevelam 625 mg tablets

Placebodrug

Placebo tablets appearing to be colesevelam

Pioglitazonedrug

30 mg or 45 mg pioglitazone therapy