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Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00485758
Recruitment Status : Completed
First Posted : June 13, 2007
Results First Posted : September 11, 2009
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant versus placebo in Type 2 Diabetes Mellitus patients.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: ER niacin/laropiprant Drug: Comparator : placebo (unspecified) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 796 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 36 Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant in Patients With Type 2 Diabetes
Study Start Date : July 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
1
Arm 1: One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study.
 Drug: ER niacin/laropiprant
One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks.
Other Names:
  • MK0524A
  • CORDAPTIVE™
  • laropiprant (+) niacin
Active Comparator: 2
Arm 2: stable lipid-modifying regimen, adding Placebo ER niacin/laropiprant in week 4, for the duration of the study.
 Drug: Comparator : placebo (unspecified)
ER niacin/laropiprant Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo [ Time Frame: Baseline and 12 Weeks ]
    After 12 Weeks of treatment, to assess the reduction of low-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo


Secondary Outcome Measures :
  1. Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo [ Time Frame: Baseline and 12 Weeks ]
    After 12 weeks of treatment, to assess the increase of high-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo

  2. Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo [ Time Frame: Baseline and 12 Weeks ]
    after 12 weeks of treatment, to assess the reduction of triglycerides in patients with Type 2 diabetes when compared to placebo


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between the ages of 18 to 80 years with Type 2 Diabetes who are on a stable dose of antidiabetic medication for at least 3 months

Exclusion Criteria:

  • Patients taking Cholestin, niacin (>50 mg/day), fibrate therapy, hormonal contraceptives, intermittent Hormone Replacement Therapy, or certain corticosteroids
  • Patients with any of the following conditions: active liver disease or kidney disease, poorly controlled high blood pressure, active peptic ulcer, or other heart or blood diseases
  • Patients with abnormal laboratory results from a blood test that will be given before starting the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485758


Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
More Information
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Publications of Results:
MacLean A, McKenney J, Scott R, Brinton E, Bays H, Mitchel Y, Paolini J, Giezek H, Vandormael K, Ruck RA, Gibson K, Sisk CM, Maccubbin D. Efficacy and safety of extended release niacin/laropiprant in patients with type 2 diabetes mellitus. Br J Cardiol. 2011;18(1):37-45.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00485758    
Other Study ID Numbers: 0524A-069
MK0524A-069
2007_543
First Posted: June 13, 2007    Key Record Dates
Results First Posted: September 11, 2009
Last Update Posted: October 12, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Niacin
Niacinamide
Nicotinic Acids
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs