At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 357 enrolled
Drug / intervention
Welchol +1 moredrug
Likely dose
Welchol 625mgfrom 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.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Welchol as Monotherapy for Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating Welchol and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 357 participants across 107 sites.
Detailed Summary
The current study investigates Welchol as monotherapy to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The study will evaluate if Welchol monotherapy 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 2008
Enrollment StartJan 2009
Primary CompletionDec 2011
TodayJul 2026
First PostedNov 13, 2008
Enrollment StartJan 1, 2009
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.6 years ago
Interventions
Welcholdrug
Welchol 625mg tablets
Placebodrug
placebo