NCT00482079

Brief Summary

A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
743

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2003

Typical duration for phase_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

May 13, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2004

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2007

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

June 1, 2007

Last Update Submit

March 24, 2017

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (1)

  • To asses the effectiveness of MK0431 compared to placebo

    over 12 weeks

Secondary Outcomes (1)

  • To test the safety and tolerability of MK0431 in patients with type 2 diabetes

Interventions

MK0431, sitagliptin phosphate / Duration of Treatment: 21 WeeksDRUG
Comparator: placebo (unspecified) / Duration of Treatment: 21 WeeksDRUG

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21 to 70, You are a man or non-pregnant woman

You may not qualify if:

  • Have a history of type I diabetes
  • You are on a weight loss program with ongoing weight loss or taking weight loss medications
  • You have a history of minor surgery
  • You have received investigational drugs within 8 weeks of study start
  • You have hepatitis B or C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Scott R, Wu M, Sanchez M, Stein P. Efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12 weeks in patients with type 2 diabetes. Int J Clin Pract. 2007 Jan;61(1):171-80. doi: 10.1111/j.1742-1241.2006.01246.x. Epub 2006 Dec 5.

    PMID: 17156104BACKGROUND

  • Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30.

    PMID: 25633134DERIVED

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2007

First Posted

June 4, 2007

Study Start

May 13, 2003

Primary Completion

August 25, 2004

Study Completion

June 15, 2006

Last Updated

March 28, 2017

Record last verified: 2017-03