| Trial ID: | L6912 |
| Source ID: | NCT00938405
|
| Associated Drug: |
Colesevelam Hcl
|
| Title: |
Efficacy of Colesevelam in Subjects With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1|Hyperlipidemias
|
| Interventions: |
DRUG: Colesevelam HCl|DRUG: Placebo
|
| Outcome Measures: |
Primary: To demonstrate a 10% LDL reduction in type 1 diabetic subjects with initial LDL > 100 after twelve weeks in the colesevelam group., 12 weeks of treatment | Secondary: To evaluate colesevelam use for glucose control as measured by A1c using a 0.4% confidence interval at baseline and after one, two, and three months of therapy., 12 weeks of treatment.|To evaluate colesevelam use for non-inferiority of percent of target range glucose values and time spent in hyper- and hypoglycemic ranges as determined by CGM readings at baseline and after one, two, and three months of therapy., 12 weeks of treatment.|In addition change in insulin dose at one, two and three months from baseline will be evaluated., 12 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver | Collaborators: Daiichi Sankyo
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
45
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-07
|
| Completion Date: |
2009-12
|
| Results First Posted: |
|
| Last Update Posted: |
2014-05-20
|
| Locations: |
Barbara Davis Center for Diabetes, Aurora, Colorado, 80045, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00938405
|
