At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 21 enrolled
Drug / intervention
Colesevelam +1 moredrug
Likely dose
Colesevelam 3.75 gfrom 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 Single-Blind Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes)
Seattle Institute for Biomedical and Clinical Research·interventional·Posted Oct 6, 2009·Updated Nov 21, 2012
In Brief
A Phase 3 clinical trial evaluating Colesevelam and placebo for Impaired Fasting Glucose and Prediabetes. Completed, enrolled 21 participants.
Detailed Summary
The objective of this study is to determine the effect of 8 weeks of treatment with colesevelam HCl 3.75 g once daily with the evening meal on ß-cell function by evaluating the acute insulin response (AIRg) to an intravenous glucose load in subjects with prediabetes (impaired fasting glucose).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImpaired Fasting Glucose, Prediabetes
Countries--
CollaboratorsVA Puget Sound Health Care System
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedOct 2009
Primary CompletionOct 2010
TodayJul 2026
First PostedOct 6, 2009
Enrollment StartSep 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.7 years ago
Interventions
Colesevelamdrug
colesevelam HCl 3.75 g once daily orally with the evening meal
placeboother
tablet (s) orally given with evening meal