Back to resultsMK0916 in Patients With Type 2 Diabetes and Metabolic Syndrome (0916-005)
Primary Purpose
Diabetes Mellitus, Type 2, Metabolic Syndrome
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0916
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00543595
Brief Title
MK0916 in Patients With Type 2 Diabetes and Metabolic Syndrome (0916-005)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0916
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21272190
Citation
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.
Results Reference
result
Learn more about this trial
MK0916 in Patients With Type 2 Diabetes and Metabolic Syndrome (0916-005)
We'll reach out to this number within 24 hrs