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A Crossover Study to Evaluate the Efficacy of Simvastatin in Elevating HDL-C Levels in Patients With Type 2 Diabetes
This study has been completed.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00389896
  Purpose

The purpose of this study is to see how well simvastatin raises HDL levels in patients with Type 2 Diabetes.


Condition Intervention Phase
HDL Cholesterol
 Drug: MK0733 / Duration of Treatment: 18 Weeks
Drug: Comparator: placebo (unspecified) / Duration of Treatment: 18 Weeks
 Phase III

MedlinePlus related topics: Diabetes
Drug Information available for: Simvastatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Balanced, Three-Way Crossover Study to Evaluate the Efficacy of Simvastatin Therapy in Elevating HDL-C Levels in Patients With Type 2 Diabetic Dyslipidemia and Low HDL-C

Further study details as provided by Merck:

Primary Outcome Measures:
  • HDL-C raising effects after 6 weeks [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Effect on other lipids and lipoproteins at 6 weeks [ Time Frame: 6 weeks ]

Estimated Enrollment: 150
Study Start Date: August 2001
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has stable Type 2 diabetes mellitus at Visit 1.
  • Patient meets screening criteria based on Visit 1 lab tests

Exclusion Criteria:

  • Patient is pregnant, breastfeeding, or at risk of becoming pregnant
  • Patient has heart disease, uncontrolled high blood pressure, or other significant disease
  • Patient is taking prohibited medication(s) and is unable to stop taking them for the duration of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389896

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

Publications:
Miller M, Dobs A, Yuan Z, Battisti WP, Palmisano J. The effect of simvastatin on triglyceride-rich lipoproteins in patients with type 2 diabetic dyslipidemia: a SILHOUETTE trial sub-study. Curr Med Res Opin. 2006 Feb;22(2):343-50.
Miller M, Dobs A, Yuan Z, Battisti WP, Borisute H, Palmisano J. Effectiveness of simvastatin therapy in raising HDL-C in patients with type 2 diabetes and low HDL-C. Curr Med Res Opin. 2004 Jul;20(7):1087-94.

Study ID Numbers: 2006_536
Study First Received: October 18, 2006
Last Updated: October 9, 2007
ClinicalTrials.gov Identifier: NCT00389896  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Simvastatin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Dyslipidemias

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
 Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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