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Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy (CERTAIN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01239004
First Posted: November 11, 2010
Last Update Posted: January 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Radiant Research
November 9, 2010
November 11, 2010
January 6, 2012
November 2010
August 2011   (Final data collection date for primary outcome measure)
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).
Low-density lipoprotein cholesterol (LDL-C) and fasting plasma glucose [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT01239004 on ClinicalTrials.gov Archive Site
  • Fasting Plasma Glucose (FPG) [ Time Frame: 12 weeks ]
    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).
  • NMR Lipid subfractions and lipoprotein-IR score [ Time Frame: 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.
  • Hemoglobin A1C (HbA1C) [ Time Frame: 12 weeks ]
    A secondary efficacy endpoint is the mean change from baseline (Week 1) to end-of-treatment(Week 12) in HbA1c.
  • Fructosamine [ Time Frame: 12 weeks ]
    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.
  • High sensitivity c-reactive protein (hs-CRP) [ Time Frame: 12 weeks ]
    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.
  • Niacin-related flushing [ Time Frame: 12 weeks ]
    Niacin-associated flushing will be measured using a visual analog scale (VAS)at Weeks 2,4,6,10 and 12.
  • Homeostasis model assessment of insulin resistance (HOMA-IR) score [ Time Frame: 12 weeks ]
    A secondary efficacy endpoint is the mean change from baseline (Week 1) to end-of-treatment (Week 12) in HOMA-IR.
  • High-density lipoprotein cholesterol (HDL-C) [ Time Frame: 12 weeks ]
    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.
  • Non-high-density lipoprotein cholesterol (non-HDL-C) [ Time Frame: 12 weeks ]
    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.
  • Total Cholesterol (TC) [ Time Frame: 12 weeks ]
    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.
  • Triglycerides (TG) [ Time Frame: 12 weeks ]
    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.
  • Fasting Insulin [ Time Frame: 12 weeks ]
    A secondary efficacy endpoint is the mean change from baseline (Week 1) to end-of-treatment (Week 12) in fasting insulin.
  • Homeostasis model assessment of insulin resistance (HOMA-IR)and lipoprotein-IR (LP-IR) score. [ Time Frame: 12 weeks ]
  • Lipid and lipoprotein subfractions profile [ Time Frame: 12 weeks ]
  • Hemoglobin A1C (HbA1C) [ Time Frame: 12 weeks ]
  • Fructosamine [ Time Frame: 12 weeks ]
  • High sensitivity c-reactive protein (hs-CRP) [ Time Frame: 12 weeks ]
  • Niacin-related flushing [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Dyslipidemia
  • Hyperlipidemia
  • Hyperglycemia
  • Drug: Placebo
    6 tablets daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks
  • Drug: Colesevelam
    6 tablets (3750 mg total) daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks
    Other Name: Welchol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Colesevelam
    Intervention: Drug: Colesevelam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
August 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Men and women ≥ 18 years of age.
  2. Non-HDL-C ≥100 mg/dL and ≤220 mg/dL at Visits 1 and 2.
  3. FPG ≥90 mg/dL and ≤145 mg/dL, at Visits 1 and 2.
  4. HDL-C <60 mg/dL at Visits 1 and 2, regardless of gender.
  5. 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:

  1. Known intolerance to niacin or bile acid-sequestering drugs or aspirin.
  2. Any contraindication to a study medication (niacin, aspirin or colesevelam).
  3. History of dysphagia, swallowing disorders or intestinal motility disorders.
  4. History of pancreatitis.
  5. Fasting TG >500 mg/dL at Visits 1 and 2
  6. Currently taking medication for diabetes mellitus, Type 1 or 2,or currently taking glucose-lowering drugs (e.g. metformin) for any other indication.
  7. 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.).
  8. Body mass index (BMI) >40 kg/m2.
  9. 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.
  10. 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.
  11. Unwilling to abstain, during the study, from weight-loss drugs (including over-the-counter) or weight-loss programs during the study.
  12. Current use, or intended use during the study, of cyclic hormones (e.g., oral or vaginal contraceptives and estrogen replacement therapy).
  13. 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.
  14. Current use, or intended use during the study of cyclosporine.
  15. 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).
  16. Exposure to any investigational agent within 30 days prior to Visit 1, and prior to randomization.
  17. 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01239004
Welchol-Niaspan 001
No
Not Provided
Not Provided
Radiant Research
Radiant Research
Not Provided
Principal Investigator: Michael H Davidson, MD, FACC Executive Medical Director, Radiant Research
Radiant Research
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP