CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Colesevelam +2 moredrug
Likely dose
Colesevelam 3.8g orally for 12 weeksAI-extracted
Key inclusion· 5
  • ✓Age 18–75 years inclusive
  • ✓Diagnosed with type 2 diabetes
  • ✓Hemoglobin A1c ≥8.0%
  • ✓Overweight or obese with BMI 25–45 kg/m²
Key exclusion· 4
  • ✕Change in dose of lipid-lowering or blood pressure medication within past 3 months
  • ✕Previous treatment with colesevelam for hyperlipidemia
  • ✕Serum triglycerides >500 mg/dL
  • ✕Serum LDL-cholesterol <60 mg/dL

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

Search/NCT00147745
NCT00147745Phase 2Completed
CompareCT.gov

Effects of Colesevelam on Insulin Sensitivity in Type 2 Diabetes Mellitus

Daiichi Sankyo·interventional·Posted Sep 7, 2005·Updated Apr 2, 2014

In Brief

A Phase 2 clinical trial evaluating Colesevelam, Colesevelam matching placebo, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 36 participants across 1 site.

Detailed Summary

This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 7, 2005
Enrollment StartJun 1, 2005
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 20.8 years ago

Interventions

Colesevelamdrug

Colesevelam 3.8g for 12 weeks

Colesevelam matching placebodrug

Colesevelam matching placebo for 12 weeks

Insulin glargine (Lantus)drug

Insulin glargine for 12 weeks