Text Size

The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)

This study has been terminated.
(Business Reasons)
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00832624
First received: January 28, 2009
Last updated: April 15, 2011
Last verified: April 2011
History of Changes
  Purpose

to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin.


Condition Intervention Phase
Diabetes Mellitus Non-insulin-dependent
 Drug: sitagliptin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Non Placebo-Controlled Study To Verify the Effect of Sitagliptin In Adult Patients With Type 2 Diabetes and Inadequate Glycemic Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: Yes ]
    Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected.


Enrollment: 10
Study Start Date: November 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
sitagliptin
 Drug: sitagliptin
Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
Other Names:
  • Sitagliptin
  • Januvia
  • MK0431

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients Who Are 18 Years Of Age With Type 2 Diabetes Mellitus Who Are Either:

    • Not On Antihyperglycemic (AHa) Medication (Off For At Least 2 Months)
    • Or On A Single AHa
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832624

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00832624     History of Changes
Other Study ID Numbers: 2009_526, MK0431-118
Study First Received: January 28, 2009
Results First Received: July 6, 2010
Last Updated: April 15, 2011
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013