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

NCT ID: NCT00389896

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-26

Study Completion Date

2002-10-04

Brief Summary

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

Detailed Description

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Conditions

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HDL Cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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MK0733 / Duration of Treatment: 18 Weeks

Intervention Type DRUG

Comparator: placebo (unspecified) / Duration of Treatment: 18 Weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type BACKGROUND
PMID: 16466606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15265253 (View on PubMed)

Other Identifiers

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2006_536

Identifier Type: -

Identifier Source: secondary_id

0733-216

Identifier Type: -

Identifier Source: org_study_id

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