| Trial ID: | L7036 |
| Source ID: | NCT00147745
|
| Associated Drug: |
Colesevelam
|
| Title: |
Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00147745/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Colesevelam|DRUG: Colesevelam matching placebo|DRUG: Insulin glargine (Lantus)
|
| Outcome Measures: |
Primary: Difference in Endogenous (Hepatic) Glucose Output During a High-dose Insulin Infusion From Baseline to After 12 Weeks of Treatment., The parameter measured is the endogenous (hepatic) glucose output during a high-dose insulin infusion. A decrease after treatment with colesevelam is indicative of greater sensitivity of the liver to insulin., Baseline to 12 weeks|Difference in Endogenous (Hepatic) Glucose Output During a Low-dose Insulin Infusion From Baseline to Week 12., The parameter measured is the endogenous (hepatic) glucose output during a low-dose insulin infusion. A decrease is indicative of greater senstitivity of the liver to insulin., Baseline to 12 weeks|Acute Effect of a Single Dose of Colesevelam on Oral Glucose Absorption From Baseline to First Dose, Change in area under the curve for glucose (AUCg) after a glucose tolerance test. A decrease in AUCg is indicative of a drug effect., Baseline (Day -4) to first dose (Day 1) | Secondary: The Acute Effect of Colesevelam (Multiple Doses) on Oral Glucose Absorption From Baseline to 12 Weeks, The parameter measured is the change in area under the curve for glucose(AUCg) after an oral glucose tolerance test. A decrease in AUCg indicative of drug effect on glucose absorption., Baseline to 12 weeks|Change in Hemoglobin A1C Due to Effect of Colesevelam From Baseline to 12 Weeks, The parameter measured is the percent of hemoglobin A that is glycosylated. A decrease in this parameter is indicative of improved glucose control., Baseline to 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Daiichi Sankyo
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
|
| Start Date: |
2005-06
|
| Completion Date: |
2008-01
|
| Results First Posted: |
2009-12-04
|
| Last Update Posted: |
2014-04-02
|
| Locations: |
San Diego VMC, San Diego, California, 92161, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00147745
|
