| Trial ID: | L7271 |
| Source ID: | NCT00361153
|
| Associated Drug: |
Colesevelam Hydrochloride
|
| Title: |
Effects on Colesevelam HC1 (WelChol®) on Insulin Sensitivity in Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Colesevelam hydrochloride|DRUG: placebo
|
| Outcome Measures: |
Primary: To evaluate the effect of 8 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method, i.e., placebo-corrected change from baseline in M-value., 8 weeks | Secondary: To evaluate the effect of 2 weeks treatment with WelChol on insulin sensitivity,as measured by the hyperinsulinemic-euglycemic clamp method., 2 weeks|To evaluate acute and chronic effects of treatment with WelChol on plasma glucose after ingestion of a standard meal replacement., 8 weeks|To evaluate the effect of treatment with WelChol on HbA1C, insulin, fasting plasma glucose, and fructosamine., 8 weeks
|
| Sponsor/Collaborators: |
Sponsor: Daiichi Sankyo
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
35
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-05
|
| Completion Date: |
2007-03
|
| Results First Posted: |
|
| Last Update Posted: |
2008-06-25
|
| Locations: |
Diabetes and Glandular Research Associates, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00361153
|
