Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy

NCT01239004 | Completed Phase 4

• 1 other identifier: Welchol-Niaspan 001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

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.

Conditions

Dyslipidemia; Hyperlipidemia; Hyperglycemia

Keywords

dyslipidemia; hyperlipidemia; hyperglycemia; impaired fasting glucose

Outcome Measures

Primary Outcomes (1)

• Low-density lipoprotein cholesterol (LDL-C)

  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 Outcomes (12)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Colesevelam

EXPERIMENTAL

Drug: Colesevelam

Interventions

Placebo DRUG

6 tablets daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks

Placebo

Colesevelam DRUG

6 tablets (3750 mg total) daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks

Also known as: Welchol

Colesevelam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 18 years of age.
• Non-HDL-C ≥100 mg/dL and ≤220 mg/dL at Visits 1 and 2.
• FPG ≥90 mg/dL and ≤145 mg/dL, at Visits 1 and 2.
• 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

You may not qualify if:

• 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/m2.
• 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).

Sponsors & Collaborators

• Radiant Research: lead

Study Sites (4)

Radiant Research

Chicago, Illinois, United States

Location

Unknown Facility

Kansas City, Kansas, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

MeSH Terms

Conditions

Dyslipidemias; Hyperlipidemias; Hyperglycemia

Interventions

Colesevelam Hydrochloride

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons

Study Officials

• Michael H Davidson, MD, FACC

  Executive Medical Director, Radiant Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 11, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 6, 2012

Record last verified: 2012-01

Locations

US (4)