Trials / Completed
CompletedNCT00993824
Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes
Use of Continuous Glucose Monitoring With Ambulatory Glucose Profile Analysis to Demonstrate the Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- HealthPartners Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to obtain continuous glucose monitoring (CGM) data from individuals taking Welchol compared to placebo. The CGM data will determine the effect on glucose control of adding Welchol to an anti-diabetic medication regimen.
Detailed description
To understand the effect of the addition of colesevelam HCl to oral agent therapy in individuals with type 2 diabetes on glycemic control by utilizing a novel technology, continuous glucose monitoring with ambulatory glucose profile analysis. To date there are no studies of this compound that have employed continuous glucose monitoring (CGM) with ambulatory glucose profile (AGP) analysis to obtain data that will detail the diurnal glucose patterns associated with this therapy. We plan to employ CGM at critical points throughout the study. AGP analysis will enable rapid assessment of the clinical status of the subject. Using statistically stable estimates of hourly values represented by five percentile curves AGP depicts glucose exposure, variability and stability. Previously, we have used AGP analysis to characterize glucose perturbations in individuals ranging from normal glucose tolerance to overt type 2 diabetes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | colesevelam HCl | 3.75 grams of colesevelam HCl (6 tablets) |
| DRUG | placebo |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2011-09-01
- Completion
- 2011-09-01
- First posted
- 2009-10-14
- Last updated
- 2015-11-30
- Results posted
- 2014-06-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00993824. Inclusion in this directory is not an endorsement.