MK0916 in Patients With Type 2 Diabetes and Metabolic Syn... | NCT00543595

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

NCT00543595

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

May 22, 2015Estimated

Enrollment

154Actual

Phase

Phase 2

Conditions

Diabetes Mellitus, Type 2
Metabolic Syndrome

Interventions

MK0916

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007_643

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

May 2005Actual

Completion Date

May 2005Actual

First Submitted Date

Oct 5, 2007

First Submission Date that Met QC Criteria

Oct 12, 2007

First Posted Date

Oct 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2015

Last Update Posted Date

May 22, 2015Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

154Actual

Name	Type	Description	Arm Group Labels	Other Names
MK0916	Drug

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21272190	Result	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D003924	Diabetes Mellitus, Type 2
D024821	Metabolic Syndrome