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The present study will assess the low-density lipoprotein cholesterol (LDL-C) lowering effect of colesevelam as an adjunct to niacin for the improvement of lipids and glycemic control in dyslipidemic subjects with impaired fasting glucose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Colesevelam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 6 tablets daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Low-density lipoprotein cholesterol (LDL-C) | The primary efficacy endpoint will be the mean percent change from baseline (average of Weeks -1 and 1) to end-of-treatment (average of Weeks 10 and 12) in LDL-C. It will be measured as part of the fasting lipid panel at Visits 1, 2, 3, 7, and 8/ET (Weeks -6 to -2, -1, 1, 10 and 12/ET). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose (FPG) | The principal secondary efficacy endpoint is the mean change in FPG from baseline (average of Weeks -1 and 1) to end-of-treatment (average of Weeks 10 and 12). | 12 weeks |
| NMR Lipid subfractions and lipoprotein-IR score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Davidson, MD, FACC | Executive Medical Director, Radiant Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Chicago | Illinois | United States | |||
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006949 | Hyperlipidemias |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D000069472 | Colesevelam Hydrochloride |
| ID | Term |
|---|---|
| D000499 | Allylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000498 | Allyl Compounds |
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| Colesevelam |
| Drug |
6 tablets (3750 mg total) daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks |
|
|
A secondary efficacy endpoint is the mean change from baseline (Week 1) to end-of-treatment(Week 12) in NMR Lipid subfractions and lipoprotein-IR score.
| 12 weeks |
| Hemoglobin A1C (HbA1C) | A secondary efficacy endpoint is the mean change from baseline (Week 1) to end-of-treatment(Week 12) in HbA1c. | 12 weeks |
| Fructosamine | A secondary efficacy endpoint is the mean change from baseline (average of Weeks -1 and 1) to end-of-treatment (average of Weeks 10 and 12) in fructosamine. | 12 weeks |
| High sensitivity c-reactive protein (hs-CRP) | A secondary efficacy endpoint is the mean change from baseline (average of Weeks -1 and 1) to end-of-treatment (average of Weeks 10 and 12) in hs-CRP. | 12 weeks |
| Niacin-related flushing | Niacin-associated flushing will be measured using a visual analog scale (VAS)at Weeks 2,4,6,10 and 12. | 12 weeks |
| Homeostasis model assessment of insulin resistance (HOMA-IR) score | A secondary efficacy endpoint is the mean change from baseline (Week 1) to end-of-treatment (Week 12) in HOMA-IR. | 12 weeks |
| High-density lipoprotein cholesterol (HDL-C) | A secondary endpoint is the mean percent change from baseline (average of Weeks -1 and 1) to end-of-treatment (average of Weeks 10 and 12) in HDL-C. | 12 weeks |
| Non-high-density lipoprotein cholesterol (non-HDL-C) | A secondary endpoint is the mean percent change from baseline (average of Weeks -1 and 1) to end-of-treatment (average of Weeks 10 and 12) in non-HDL-C. | 12 weeks |
| Total Cholesterol (TC) | A secondary endpoint is the mean percent change from baseline (average of Weeks -1 and 1) to end-of-treatment (average of Weeks 10 and 12) in TC. | 12 weeks |
| Triglycerides (TG) | A secondary endpoint is the mean percent change from baseline (average of Weeks -1 and 1) to end-of-treatment (average of Weeks 10 and 12) in TG. | 12 weeks |
| Fasting Insulin | A secondary efficacy endpoint is the mean change from baseline (Week 1) to end-of-treatment (Week 12) in fasting insulin. | 12 weeks |
| Kansas City |
| Kansas |
| United States |
| Minneapolis | Minnesota | United States |
| St Louis | Missouri | United States |
| D000475 |
| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |