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A Post Marketing Safety Study of Sitagliptin Phosphate/Metformin Hydrochloride (JANUMET®) (MK-0431A-235)

This study has been terminated.
(Completion of MK-0431A-235 was rendered unnecessary, as the local oversight authority accepted in its stead the results of another study [MK-0431-234].)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357148
First Posted: May 20, 2011
Last Update Posted: August 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The primary objective of this study is to obtain safety information on the use of sitagliptin phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists, diabetologists, internists, and general practitioners.

Condition Intervention
Diabetes Mellitus, Type 2 Drug: Sitagliptin Phosphate/Metformin HCl (JANUMET®)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sitagliptin Phosphate/Metformin HCl (JANUMET®) Post Marketing Surveillance Protocol

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With an Adverse Event [ Time Frame: Up to approximately 28 months ]
  • Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl [ Time Frame: Up to approximately 28 months ]
  • Number of Participants With Concomitant Conditions [ Time Frame: Up to approximately 28 months ]
  • Number of Participants Taking Concomitant Medications [ Time Frame: Up to approximately 28 months ]

Enrollment: 143
Study Start Date: March 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants treated with sitagliptin phosphate/metformin HCl Drug: Sitagliptin Phosphate/Metformin HCl (JANUMET®)
Participants prescribed Sitagliptin Phosphate/Metformin HCl (JANUMET®) in routine clinical practice.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with type 2 diabetes mellitus who are treated with sitagliptin phosphate/metformin HCl as per the standard of care in a physician's practice
Criteria

Inclusion Criteria:

  • Must be taking sitagliptin phosphate/metformin HCl (JANUMET®) for the treatment of type 2 diabetes mellitus
  • Treating physician must agree to provide information regarding the participant's treatment
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01357148     History of Changes
Other Study ID Numbers: 0431A-235
First Submitted: May 18, 2011
First Posted: May 20, 2011
Results First Submitted: February 1, 2012
Results First Posted: March 7, 2012
Last Update Posted: August 10, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action