NCT01239004CompletedPhase 4
A 12-Week, Double-Blind, Randomized, Placebo-Controlled Study to Assess the LDL Cholesterol Lowering and Anti-Hyperglycemic Efficacy of Welchol® (Colesevelam) in Subjects With Impaired Fasting Glucose Who Are Taking Niaspan® (Niacin) for Dyslipidemia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Radiant Research
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Low-density lipoprotein cholesterol (LDL-C)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women ≥ 18 years of age.
- •Non-HDL-C ≥100 mg/dL and ≤220 mg/dL at Visits 1 and
- •FPG ≥90 mg/dL and ≤145 mg/dL, at Visits 1 and
- •HDL-C <60 mg/dL at Visits 1 and 2, regardless of gender.
- •Untreated dyslipidemia, or statin treatment only with equipotency to atorvastatin ≤40 mg daily for at least 12 weeks prior to Screening Visit 1 and without change or initiation prior to randomization
Exclusion Criteria
- •Known intolerance to niacin or bile acid-sequestering drugs or aspirin.
- •Any contraindication to a study medication (niacin, aspirin or colesevelam).
- •History of dysphagia, swallowing disorders or intestinal motility disorders.
- •History of pancreatitis.
- •Fasting TG >500 mg/dL at Visits 1 and 2
- •Currently taking medication for diabetes mellitus, Type 1 or 2,or currently taking glucose-lowering drugs (e.g. metformin) for any other indication.
- •Currently taking drugs that may affect glycemic and/or lipid control (e.g., beta-blockers, etc.) if started within the 12 weeks prior to Visit 1, or prior to randomization. This does not apply to dietary supplements.).
- •Body mass index (BMI) >40 kg/m
- •History of acute myocardial infarction, unstable angina, transient ischemic attacks, stroke or revascularization procedure within the 3 months prior to Visit 1 or prior to randomization.
- •Use of prescription strength niacin, bile acid sequestrants, fibrates or omega-3 fatty acids within 8 weeks prior to Visit 1 or prior to randomization. This does not apply to dietary supplements.
- •Unwilling to abstain, during the study, from weight-loss drugs (including over-the-counter) or weight-loss programs during the study.
- •Current use, or intended use during the study, of cyclic hormones (e.g., oral or vaginal contraceptives and estrogen replacement therapy).
- •Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential not using an acceptable method of contraception. Acceptable methods include intrauterine device, cervical diaphragm plus spermicide, female condom plus spermicide, or partner's use of condoms plus spermicide. Partner's vasectomy only or use of condoms or spermicide only are not considered acceptable forms of birth control.
- •Current use, or intended use during the study of cyclosporine.
- •Recent history (past 12 months) of illicit drug use or excessive ethanol use. Excessive ethanol use will be defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
- •Exposure to any investigational agent within 30 days prior to Visit 1, and prior to randomization.
- •Individual has a condition the Investigator believes would interfere with his ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Colesevelam
Experimental
Intervention: Colesevelam (Drug)
Outcomes
Primary Outcomes
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: 12 weeks
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).
Secondary Outcomes
- Fasting Plasma Glucose (FPG)(12 weeks)
- NMR Lipid subfractions and lipoprotein-IR score(12 weeks)
- Hemoglobin A1C (HbA1C)(12 weeks)
- Fructosamine(12 weeks)
- High sensitivity c-reactive protein (hs-CRP)(12 weeks)
- Niacin-related flushing(12 weeks)
- Homeostasis model assessment of insulin resistance (HOMA-IR) score(12 weeks)
- High-density lipoprotein cholesterol (HDL-C)(12 weeks)
- Non-high-density lipoprotein cholesterol (non-HDL-C)(12 weeks)
- Total Cholesterol (TC)(12 weeks)
- Triglycerides (TG)(12 weeks)
- Fasting Insulin(12 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese SubjectsHypercholesterolemiaNCT02055976Pfizer218
Completed
Phase 2
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin IntoleranceHypercholesterolemiaNCT01751984Esperion Therapeutics, Inc.56
Completed
Phase 2
A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With HypercholesterolemiaHypercholesterolemiaNCT04784442Otsuka Pharmaceutical Co., Ltd.188
Completed
Phase 3
Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and TaiwanHypercholesterolemiaNCT02289963Sanofi199
Completed
Phase 3
Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)HypercholesterolemiaNCT02023879Sanofi233