NCT00371007

Brief Summary

A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Trial Health

100
On Track

Trial Health Score

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

Enrollment
126

participants targeted

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

Timeline
Completed

Started Jun 2004

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

June 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

August 31, 2006

Last Update Submit

March 31, 2017

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c, safety and tolerability

Secondary Outcomes (1)

  • Plasma glucose

Interventions

MK0431, sitagliptin phosphate / Duration of Treatment: 12 WeeksDRUG
Comparator : placebo (unspecified) / Duration of Treatment: 12 WeeksDRUG

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients have type 2 diabetes mellitus
  • On diet/exercise therapy

You may not qualify if:

  • Patients have type 1 diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nonaka K, Kakikawa T, Sato A, Okuyama K, Fujimoto G, Kato N, Suzuki H, Hirayama Y, Ahmed T, Davies MJ, Stein PP. Efficacy and safety of sitagliptin monotherapy in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract. 2008 Feb;79(2):291-8. doi: 10.1016/j.diabres.2007.08.021. Epub 2007 Oct 22.

    PMID: 17933414BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin PhosphateDuration of Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

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

August 31, 2006

First Posted

September 1, 2006

Study Start

June 1, 2004

Primary Completion

April 25, 2005

Study Completion

April 25, 2005

Last Updated

April 4, 2017

Record last verified: 2017-03