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
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
Hyperlipidemia
Hyperglycemia
Drug: Placebo
Drug: Colesevelam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Radiant Research:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 140
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
6 tablets daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks
Experimental: Colesevelam 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239004

Locations
United States, Illinois
Radiant Research
Chicago, Illinois, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
St Louis, Missouri, United States
Sponsors and Collaborators
Radiant Research
Investigators
Principal Investigator: Michael H Davidson, MD, FACC Executive Medical Director, Radiant Research
  More Information

No publications provided

Responsible Party: Radiant Research
ClinicalTrials.gov Identifier: NCT01239004     History of Changes
Other Study ID Numbers: Welchol-Niaspan 001
Study First Received: November 9, 2010
Last Updated: January 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Radiant Research:
dyslipidemia
hyperlipidemia
hyperglycemia
impaired fasting glucose

Additional relevant MeSH terms:
Dyslipidemias
Hyperglycemia
Hyperlipidemias
Prediabetic State
Lipid Metabolism Disorders
Metabolic Diseases
Glucose Metabolism Disorders
Diabetes Mellitus
Endocrine System Diseases
Colesevelam
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014