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

Diabetes Mellitus, Type 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543595
• Other study ID #: 0916-005
• Secondary ID: 2007_643
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2007
• Last updated: May 21, 2015
• Start date: August 2004
• Est. completion date: May 2005

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• MK0916

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Feig PU, Shah S, Hermanowski-Vosatka A, Plotkin D, Springer MS, Donahue S, Thach C, Klein EJ, Lai E, Kaufman KD. Effects of an 11ß-hydroxysteroid dehydrogenase type 1 inhibitor, MK-0916, in patients with type 2 diabetes mellitus and metabolic syndrome. Di — View Citation