Extended Niacin/Laropiprant in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00485758

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus Type 2	Drug: ER niacin/laropiprant Drug: Comparator : placebo (unspecified)	Phase III

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, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

Reduction of LDL-C in patients with Type 2 diabetes when compared to placebo [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Increase in HDL-C in patients with Type 2 diabetes when compared to placebo [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	700
Study Start Date:	July 2007
Study Completion Date:	October 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
2: Active Comparator Arm 2: stable lipid-modifying regimen, adding Pbo ER niacin/laropiprant in week 4, for the duration of the study.	Drug: Comparator : placebo (unspecified) ER niacin/laropiprant Pbo

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485758

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

(MedWatch - FDA maintained medical product safety Information) This link exits the ClinicalTrials.gov site

(PhRMA Clinical Study Results Database - web-based repository for clinical study results) This link exits the ClinicalTrials.gov site

(Merck: Patient & Caregiver U.S. Product Web Site) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_543, MK0524A-069
Study First Received:	June 12, 2007
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00485758 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