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

January 5, 2012 updated by: Radiant Research

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States
        • Radiant Research
    • Kansas
      • Kansas City, Kansas, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • St Louis, Missouri, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
6 tablets daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks
Experimental: Colesevelam
6 tablets (3750 mg total) daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks
Other Names:
  • Welchol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael H Davidson, MD, FACC, Executive Medical Director, Radiant Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 9, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 6, 2012

Last Update Submitted That Met QC Criteria

January 5, 2012

Last Verified

January 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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