MK0916 in Patients With Type 2 Diabetes and Metabolic Syndrome (0916-005)

NCT ID: NCT00543595

Last Updated: 2015-05-22

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

PHASE2

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-05-31

Brief Summary

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This study will test the safety and effectiveness of MK0916 in patients with Type 2 Diabetes Mellitus and Metabolic Syndrome.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0916

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have Type 2 Diabetes
* 18 to 65 years of age

Exclusion Criteria

* History of Type 1 Diabetes Mellitus
* Have been treated with insulin in the past 8 weeks
* On a weight loss program and have ongoing weight loss
* Taking weight loss medication
* Have had surgery requiring general anesthesia in the past 30 days or have a planned surgery
* Have taken another investigational drug in the last 8 weeks
* Have active liver disease
* Have a history of major surgery involving gastric or intestinal bypass
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

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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Feig PU, Shah S, Hermanowski-Vosatka A, Plotkin D, Springer MS, Donahue S, Thach C, Klein EJ, Lai E, Kaufman KD. Effects of an 11beta-hydroxysteroid dehydrogenase type 1 inhibitor, MK-0916, in patients with type 2 diabetes mellitus and metabolic syndrome. Diabetes Obes Metab. 2011 Jun;13(6):498-504. doi: 10.1111/j.1463-1326.2011.01375.x.

Reference Type RESULT
PMID: 21272190 (View on PubMed)

Other Identifiers

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2007_643

Identifier Type: -

Identifier Source: secondary_id

0916-005

Identifier Type: -

Identifier Source: org_study_id

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