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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
140
6 tablets daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks
6 tablets (3750 mg total) daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks
Radiant Research
Chicago, Illinois, United States
Unnamed facility
Kansas City, Kansas, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
St Louis, Missouri, United States
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).
Time frame: 12 weeks
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).
Time frame: 12 weeks
NMR Lipid subfractions and lipoprotein-IR score
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Niacin-related flushing
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Niacin-associated flushing will be measured using a visual analog scale (VAS)at Weeks 2,4,6,10 and 12.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks