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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00832624
First received: January 28, 2009
Last updated: April 15, 2011
Last verified: April 2011
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
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 April 21, 2014