A Post Marketing Safety Study of Sitagliptin Phosphate/Metformin Hydrochloride (JANUMET®) (MK-0431A-235)
Terminated
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01357148
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 143
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants treated with sitagliptin phosphate/metformin HCl Sitagliptin Phosphate/Metformin HCl (JANUMET®) -
- Primary Outcome Measures
Name Time Method Number of Participants With an Adverse Event Up to approximately 28 months Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl Up to approximately 28 months Number of Participants Taking Concomitant Medications Up to approximately 28 months Number of Participants With Concomitant Conditions Up to approximately 28 months
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the safety profile of sitagliptin phosphate/metformin HCl in type 2 diabetes management?
How does the DPP-4 inhibitor and biguanide combination in JANUMET® compare to standard-of-care treatments for type 2 diabetes in terms of adverse event profiles?
Are there specific biomarkers that predict patient response to sitagliptin/metformin combination therapy in type 2 diabetes mellitus?
What are the potential drug-drug interactions and adverse event management strategies for sitagliptin phosphate/metformin HCl in post-marketing surveillance?
How does the safety profile of JANUMET® compare to other DPP-4 inhibitor/metformin combination therapies in type 2 diabetes treatment?