Clinical trial NCT01239004: Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Hyperlipidemia
Hyperglycemia
Keywords: dyslipidemia
hyperlipidemia
hyperglycemia
impaired fasting glucose
Lead sponsor: Radiant Research
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: 12 weeks
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG)
timeFrame: 12 weeks
measure: NMR Lipid subfractions and lipoprotein-IR score
timeFrame: 12 weeks
measure: Hemoglobin A1C (HbA1C)
timeFrame: 12 weeks
measure: Fructosamine
timeFrame: 12 weeks
measure: High sensitivity c-reactive protein (hs-CRP)
timeFrame: 12 weeks
measure: Niacin-related flushing
timeFrame: 12 weeks
measure: Homeostasis model assessment of insulin resistance (HOMA-IR) score
timeFrame: 12 weeks
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: 12 weeks
measure: Non-high-density lipoprotein cholesterol (non-HDL-C)
timeFrame: 12 weeks
measure: Total Cholesterol (TC)
timeFrame: 12 weeks
measure: Triglycerides (TG)
timeFrame: 12 weeks
measure: Fasting Insulin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: Minneapolis
country: United States
state: Minnesota
city: St Louis
country: United States
state: Missouri
Study officials:
affiliation: Executive Medical Director, Radiant Research
name: Michael H Davidson, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: