NCT00543595

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_2 diabetes-mellitus-type-2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 15, 2007

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

9 months

First QC Date

October 5, 2007

Last Update Submit

May 21, 2015

Conditions

Diabetes Mellitus, Type 2Metabolic Syndrome

Interventions

MK0916DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have Type 2 Diabetes
  • to 65 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 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.

    PMID: 21272190RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Metabolic Syndrome

Interventions

MK-0916

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 15, 2007

Study Start

August 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

May 22, 2015

Record last verified: 2015-05