A Crossover Study to Evaluate the Efficacy of Simvastatin in Elevating HDL-C Levels in Patients With Type 2 Diabetes (0733-216)(COMPLETED)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: October 18, 2006
Last updated: May 18, 2015
Last verified: May 2015
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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 Sharp & Dohme Corp.:

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: July 2001
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00389896

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00389896     History of Changes
Other Study ID Numbers: 0733-216  2006_536 
Study First Received: October 18, 2006
Last Updated: May 18, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2016