NCT00389896

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2001

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2001

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2002

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

October 18, 2006

Last Update Submit

August 12, 2024

Conditions

HDL Cholesterol

Outcome Measures

Primary Outcomes (1)

  • HDL-C raising effects after 6 weeks

    6 weeks

Secondary Outcomes (1)

  • Effect on other lipids and lipoproteins at 6 weeks

    6 weeks

Interventions

MK0733 / Duration of Treatment: 18 WeeksDRUG
Comparator: placebo (unspecified) / Duration of Treatment: 18 WeeksDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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. doi: 10.1185/030079906X80521.

    PMID: 16466606BACKGROUND

  • 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. doi: 10.1185/030079904125004105.

    PMID: 15265253BACKGROUND

MeSH Terms

Interventions

Duration of Therapy

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2006

First Posted

October 19, 2006

Study Start

July 26, 2001

Primary Completion

October 4, 2002

Study Completion

October 4, 2002

Last Updated

August 15, 2024

Record last verified: 2022-02