At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 169 enrolled
Drug / intervention
Colesevelam HCl +2 moredrug
Likely dose
Colesevelam HCl 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.
Effects of Colesevelam HCl, Avandia® (Rosiglitazone Maleate), or JanuviaTM (Sitagliptin) on Glycemic Parameters and Lipid Profiles in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy
In Brief
A Phase 3 clinical trial evaluating Colesevelam HCl, rosiglitazone maleate, and 1 other intervention for Type 2 Diabetes and Hyperlipidemia. Completed, enrolled 169 participants across 20 sites.
Detailed Summary
A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes, Hyperlipidemia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedJun 2007
Primary CompletionApr 2008
TodayJul 2026
First PostedJun 8, 2007
Enrollment StartMay 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.1 years ago
Interventions
Colesevelam HCldrug
coleveselam tablets 625 mg; 6 tablets/day
rosiglitazone maleatedrug
rosiglitazone tablets 4mg
sitagliptin phosphatedrug
sitagliptin phosphate tablets 100mg/day