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

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ClinicalTrials.gov Identifier: NCT01357148
Recruitment Status : 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].)
First Posted : May 20, 2011
Results First Posted : March 7, 2012
Last Update Posted : August 10, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Sitagliptin Phosphate/Metformin HCl (JANUMET®)

Study Type : Observational
Actual Enrollment : 143 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sitagliptin Phosphate/Metformin HCl (JANUMET®) Post Marketing Surveillance Protocol
Study Start Date : March 2009
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Participants treated with sitagliptin phosphate/metformin HCl Drug: Sitagliptin Phosphate/Metformin HCl (JANUMET®)
Participants prescribed Sitagliptin Phosphate/Metformin HCl (JANUMET®) in routine clinical practice.

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

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

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01357148     History of Changes
Other Study ID Numbers: 0431A-235
First Posted: May 20, 2011    Key Record Dates
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
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action