Trial Outcomes & Findings for A Post Marketing Safety Study of Sitagliptin Phosphate/Metformin Hydrochloride (JANUMET®) (MK-0431A-235) (NCT NCT01357148)

Results Overview

Recruitment status

TERMINATED

Target enrollment

143 participants

Primary outcome timeframe

Up to approximately 28 months

Results posted on

2015-08-10

Participant Flow

This was a postmarketing, safety study of participants with Type 2 diabetes mellitus prescribed sitagliptin phosphate/metformin HCL (JANUMET®) in clinical practices in the Philippines from January 2009 to May 2010.

Participant milestones

Participant milestones
Measure	Sitagliptin Phosphate/Metformin HCl Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
Overall Study STARTED	143
Overall Study COMPLETED	143
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin Phosphate/Metformin HCl n=143 Participants Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
Age, Continuous	51 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex/Gender, Customized Female	74 participants n=5 Participants
Sex/Gender, Customized Male	66 participants n=5 Participants
Sex/Gender, Customized Unspecified	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 28 months

Outcome measures

Outcome measures
Measure	Sitagliptin Phosphate/Metformin HCl n=143 Participants Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
Number of Participants With an Adverse Event	6 participants

PRIMARY outcome

Timeframe: Up to approximately 28 months

Outcome measures

Outcome measures
Measure	Sitagliptin Phosphate/Metformin HCl n=143 Participants Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl	51 years Standard Deviation 13.2

PRIMARY outcome

Timeframe: Up to approximately 28 months

Outcome measures

Outcome measures
Measure	Sitagliptin Phosphate/Metformin HCl n=143 Participants Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
Number of Participants With Concomitant Conditions	100 participants

PRIMARY outcome

Timeframe: Up to approximately 28 months

Outcome measures

Outcome measures
Measure	Sitagliptin Phosphate/Metformin HCl n=143 Participants Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
Number of Participants Taking Concomitant Medications	86 participants

Adverse Events

Sitagliptin Phosphate/Metformin HCl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place