DyslipidemiaPhase 4CERTAINNCT01239004
Colesevelam Treatment for Impaired Fasting Glucose During Niacin Therapy
A Phase 4 study testing Colesevelam in people with Dyslipidemia and Hyperlipidemia, run by Radiant Research at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia, Hyperlipidemia, Hyperglycemia
- What is being tested?
- Colesevelam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2010to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
- Exposure to any investigational agent within 30 days prior to Visit 1, and prior to randomization.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Radiant Research
Chicago, Illinois
Study site
Kansas City, Kansas
Study site
Minneapolis, Minnesota
Study site
St Louis, Missouri
About this study
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
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
- Being tested
- Placebo, Colesevelam
- Keywords
- dyslipidemia, hyperlipidemia, hyperglycemia, impaired fasting glucose
- Medical subject headings
- Dyslipidemias, Hyperlipidemias, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
6 tablets daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks
ColesevelamDrug
Also called Welchol
6 tablets (3750 mg total) daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Colesevelam | Experimental | Not described Receives: Drug: Colesevelam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (12)
Fasting Plasma Glucose (FPG)
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).
Measured: 12 weeks
NMR Lipid subfractions and lipoprotein-IR score
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.
Measured: 12 weeks
Hemoglobin A1C (HbA1C)
A secondary efficacy endpoint is the mean change from baseline (Week 1) to end-of-treatment(Week 12) in HbA1c.
Measured: 12 weeks
Fructosamine
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.
Measured: 12 weeks
High sensitivity c-reactive protein (hs-CRP)
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.
Measured: 12 weeks
Niacin-related flushing
Niacin-associated flushing will be measured using a visual analog scale (VAS)at Weeks 2,4,6,10 and 12.
Measured: 12 weeks
Homeostasis model assessment of insulin resistance (HOMA-IR) score
A secondary efficacy endpoint is the mean change from baseline (Week 1) to end-of-treatment (Week 12) in HOMA-IR.
Measured: 12 weeks
High-density lipoprotein cholesterol (HDL-C)
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.
Measured: 12 weeks
Non-high-density lipoprotein cholesterol (non-HDL-C)
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.
Measured: 12 weeks
Total Cholesterol (TC)
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.
Measured: 12 weeks
Triglycerides (TG)
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.
Measured: 12 weeks
Fasting Insulin
A secondary efficacy endpoint is the mean change from baseline (Week 1) to end-of-treatment (Week 12) in fasting insulin.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiant Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael H Davidson, MD, FACC, Principal investigator, Executive Medical Director, Radiant Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239004
- Sponsor's protocol ID
- Welchol-Niaspan 001
- Acronym
- CERTAIN
- Status last verified
- Jan 2012
- First submitted
- 9 Nov 2010
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01239004
- Acronym / sponsor ID
- CERTAIN / Welchol-Niaspan 001
- Conditions
- Dyslipidemia, Hyperlipidemia, Hyperglycemia
- Keywords
- dyslipidemia, hyperlipidemia, hyperglycemia, impaired fasting glucose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Radiant ResearchUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Colesevelam | Experimental | Drug: Colesevelam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo6 tablets daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks | Drug | Placebo |
| ColesevelamAlso: Welchol6 tablets (3750 mg total) daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks | Drug | Colesevelam |
Primary outcome
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 secondary outcomes
Fasting Plasma Glucose (FPG)
Time frame: 12 weeks
NMR Lipid subfractions and lipoprotein-IR score
Time frame: 12 weeks
Hemoglobin A1C (HbA1C)
Time frame: 12 weeks
Fructosamine
Time frame: 12 weeks
High sensitivity c-reactive protein (hs-CRP)
Time frame: 12 weeks
Niacin-related flushing
Time frame: 12 weeks
Homeostasis model assessment of insulin resistance (HOMA-IR) score
Time frame: 12 weeks
High-density lipoprotein cholesterol (HDL-C)
Time frame: 12 weeks
Non-high-density lipoprotein cholesterol (non-HDL-C)
Time frame: 12 weeks
Total Cholesterol (TC)
Time frame: 12 weeks
Triglycerides (TG)
Time frame: 12 weeks
Fasting Insulin
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Davidson, MD, FACC principal investigator
Executive Medical Director, Radiant Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colesevelam in people with Dyslipidemia and Hyperlipidemia, run by Radiant Research at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low-density lipoprotein cholesterol (LDL-C) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2012.