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

Terminated

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Sitagliptin Phosphate/Metformin HCl (JANUMET®)

• 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

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-05-19
• Study First Posted: 2011-05-20
• Results First Submitted: 2012-02-01
• Results First Submitted QC: 2012-02-01
• Results First Posted: 2012-03-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-07
• Last Update Posted: 2015-08-10

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
Number of Participants With Concomitant Conditions	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