| Trial ID: | L4332 |
| Source ID: | NCT00484419
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| Associated Drug: |
Colesevelam Hcl
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| Title: |
Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin
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| Acronym: |
|
| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00484419/results
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| Conditions: |
Type 2 Diabetes|Hyperlipidemia
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| Interventions: |
DRUG: Colesevelam HCl|DRUG: rosiglitazone maleate|DRUG: sitagliptin phosphate
|
| Outcome Measures: |
Primary: Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint, Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0., 16 weeks change = week 16 - week 0. | Secondary: Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean, Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0., 16 weeks change = week 16 - week 0.|Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8, change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0., 8 weeks change = week 8- week 0.|Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean, change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0., 8 weeks change = week 8- week 0.|Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean, change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0., 16 weeks change = week 16 - week 0.|Mean Change in FPG From Week 0(Baseline) to Week 8, mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0., 8 weeks change = week 8- week 0.|Mean Change in FPG From Week 0(Baseline) to Week 16, change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0., 16 weeks change = week 16 - week 0.|Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean, change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0., 8 weeks change = week 8- week 0.|Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean, change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0., 16 weeks change = week 16 - week 0.|Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8, mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0., 8 weeks change = week 8- week 0.|Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16, mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0., 16 weeks change = week 16 - week 0.|Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean, change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0., 16 weeks change = week 16 - week 0.|Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16, mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0., 16 weeks change = week 16 - week 0.|Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16, mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0., 16 weeks change = week 16 - week 0.|Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean, change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0., 16 weeks change = week 16 - week 0.|Mean Change in LDL-C From Week 0(Baseline) to Week 16, mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0., 16 weeks change = week 16 - week 0.|Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16, mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0., 16 weeks change = week 16 - week 0.|Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean), percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval), 16 weeks change = week 16 - week 0.
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| Sponsor/Collaborators: |
Sponsor: Daiichi Sankyo
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
169
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2007-05
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| Completion Date: |
2008-04
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| Results First Posted: |
2009-06-17
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| Last Update Posted: |
2016-10-04
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| Locations: |
La Mesa, California, United States|Los Angeles, California, United States|Los Gatos, California, United States|San Antonio, California, United States|Chiefland, Florida, United States|Gary, Indiana, United States|Baltimore, Maryland, United States|Dearborn, Michigan, United States|W. Bloomfield, Michigan, United States|Las Vegas, Nevada, United States|Yonkers, New York, United States|Lexington, North Carolina, United States|Winston-Salem, North Carolina, United States|Munroe Falls, Ohio, United States|Zaneville, Ohio, United States|Portland, Oregon, United States|Jersey Shore, Pennsylvania, United States|Clemson, South Carolina, United States|Harriman, Tennessee, United States|Dallas, Texas, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00484419
|
