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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radiant Research
ClinicalTrials.gov Identifier:
NCT01239004
First received: November 9, 2010
Last updated: January 5, 2012
Last verified: January 2012

November 9, 2010
January 5, 2012
November 2010
August 2011   (final data collection date for primary outcome measure)
Low-density lipoprotein cholesterol (LDL-C) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01239004 on ClinicalTrials.gov Archive Site
  • Fasting Plasma Glucose (FPG) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Lipid and lipoprotein subfractions profile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Hemoglobin A1C (HbA1C) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Fructosamine [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • High sensitivity c-reactive protein (hs-CRP) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Niacin-related flushing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01239004
Welchol-Niaspan 001
No
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