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A Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites
This study has been completed.
First Received: February 8, 2008   Last Updated: April 1, 2009   History of Changes
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00618995
  Purpose

The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a specific metabolite (which is a marker of in vivo platelet reactivity).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Comparator: ER niacin (+) laropiprant
Drug: Comparator: ER niacin
Drug: Comparator: laropiprant
Drug: Comparator: placebo
Phase I

MedlinePlus related topics: Diabetes
Drug Information available for: Niacin Niacinamide Laropiprant Niacin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 4-Period, Crossover Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With Type 2 Diabetes

Further study details as provided by Merck:

Primary Outcome Measures:
  • Urinary 11-Dehydrothromboxane B2 (11-dTxB2) [ Time Frame: On Day 7 across the 24-hour urinary collection period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prostaglandin I Metabolite (PGI-M) [ Time Frame: On Day 7 across the 24-hour urinary collection period. ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: September 2007
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Arm A: ER niacin/laropiprant + Placebo to laropiprant
Drug: Comparator: ER niacin (+) laropiprant
ER niacin 2 g/ laropiprant 40 mg daily for 7 days.
B: Experimental
Arm B: ER niacin + Placebo to laropiprant
Drug: Comparator: ER niacin
ER niacin 2 g daily for 7 days.
C: Experimental
Arm C: laropiprant + Placebo to ER Niacin/laropiprant
Drug: Comparator: laropiprant
laropiprant 40 mg daily for 7 days.
D: Placebo Comparator
Arm D: Placebo
Drug: Comparator: placebo
matching placebo tablets for each of the interventions once daily for 7 days

Detailed Description:

Subjects will receive 1 of 4 treatments per period and will eventually receive all 4 treatments:

Treatment A: ER niacin 2g/laropiprant 40 mg daily + Placebo to laropiprant for 7 days

Treatment B: ER niacin 2 g daily + Placebo to laropiprant for 7 days

Treatment C: laropiprant 40 mg daily + Placebo to ER niacin/laropiprant for 7 days

Treatment D: placebo daily for 7 days. There will be at least a 7-day interval between dosing on Day 7 of a period and dosing on Day 1 of the subsequent period

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female subjects may not be pregnant and/or will agree to use appropriate method of contraception beginning at least 2 weeks prior to administration of the first dose of study drug in the first treatment period, throughout the study and until at least 2 weeks after administration of the last dose of study drug in the last treatment period
  • Subject has a history of T2DM either treated with diet and exercise alone or with metformin or a sulfonylurea
  • Subject is judged to be in good health (other than history of Type 2 diabetes mellitus) based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
  • Subject has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
  • Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months; subjects who have discontinued smoking or the use of nicotine/nicotine containing products for at least approximately 3 months may be enrolled in the study at the discretion of the investigator

Exclusion Criteria:

  • Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 to 10 years
  • Subject has a history of stroke, chronic seizures, or major neurological disorder
  • Subject has a history of clinically significant endocrine (except for Type 2 diabetes mellitus), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
  • Subject has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment
  • Subject has history of a blood or platelet related disorder including prior deep venous thrombosis. Subject is being treated with coumadin, heparin, clopidogrel or has used these agents within 2 weeks of screening. Subject is being treated with aspirin or has used this agent within 3 weeks prior to administration of screening
  • Subject is unable to refrain from or anticipates the use of any medication (with the exception of metformin or sulfonylurea agents), including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks until the post-study visit. No concomitant medications may be taken during the study
  • Subject consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages, per day
  • Subject consumes excessive amounts, defined as greater than 6, of coffee, tea, cola, or other caffeinated beverages per day
  • Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit
  • Subject has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
  • Subject uses insulin, PPAR gamma agonists (rosiglitazone or pioglitazone), exenatide (Byetta), acarbose (Prandase, Precose) or dipeptidyl-peptidase 4 (DPP-4) inhibitors (JANUVIA™1)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618995

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2008_508, MK0524A-079
Study First Received: February 8, 2008
Results First Received: December 5, 2008
Last Updated: April 1, 2009
ClinicalTrials.gov Identifier: NCT00618995     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antimetabolites
Vasodilator Agents
Vitamin B Complex
Metabolic Diseases
Niacinamide
Antilipemic Agents
Diabetes Mellitus
Endocrine System Diseases
Trace Elements
Cardiovascular Agents
Nicotinic Acids
Vitamins
Diabetes Mellitus, Type 2
Micronutrients
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Niacin

Additional relevant MeSH terms:
Antimetabolites
Vasodilator Agents
Vitamin B Complex
Metabolic Diseases
Niacinamide
Molecular Mechanisms of Pharmacological Action
Growth Substances
Antilipemic Agents
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Pharmacologic Actions
Nicotinic Acids
Vitamins
Therapeutic Uses
Diabetes Mellitus, Type 2
Micronutrients
Glucose Metabolism Disorders
Niacin

ClinicalTrials.gov processed this record on May 07, 2009