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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01357148
First received: May 18, 2011
Last updated: August 6, 2014
Last verified: August 2014
  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 ] [ Designated as safety issue: Yes ]
  • Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl [ Time Frame: Up to approximately 28 months ] [ Designated as safety issue: No ]
  • Number of Participants With Concomitant Conditions [ Time Frame: Up to approximately 28 months ] [ Designated as safety issue: No ]
  • Number of Participants Taking Concomitant Medications [ Time Frame: Up to approximately 28 months ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01357148     History of Changes
Other Study ID Numbers: 0431A-235
Study First Received: May 18, 2011
Results First Received: February 1, 2012
Last Updated: August 6, 2014
Health Authority: Philippines: Bureau of Food and Drugs

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

ClinicalTrials.gov processed this record on October 20, 2014