Trial Outcomes & Findings for A Post Marketing Safety Study of Sitagliptin (JANUVIA®) (MK-0431-234) (NCT NCT01354990)

Results Overview

Recruitment status

COMPLETED

Target enrollment

2974 participants

Primary outcome timeframe

Up to approximately 28 months

Results posted on

2015-08-27

Participant Flow

This was a postmarketing, safety study of participants with Type 2 diabetes mellitus prescribed sitagliptin phosphate (JUNUVIA®) in clinical practices in the Philippines.

Participant milestones

Participant milestones
Measure	Sitagliptin Phosphate (JANUVIA®) Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
Overall Study STARTED	2974
Overall Study COMPLETED	2974
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Post Marketing Safety Study of Sitagliptin (JANUVIA®) (MK-0431-234)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin Phosphate (JANUVIA®) n=2974 Participants Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
Age, Customized 0 - 19	0 participants 12.2 • n=5 Participants
Age, Customized 20 - 99	2926 participants n=5 Participants
Age, Customized Unspecified	48 participants n=5 Participants
Sex/Gender, Customized Female	1577 participants n=5 Participants
Sex/Gender, Customized Male	1351 participants n=5 Participants
Sex/Gender, Customized Unspecified	46 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 28 months

Outcome measures

Outcome measures
Measure	Sitagliptin Phosphate (JANUVIA®) n=2974 Participants Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
Number of Participants With an Adverse Event	25 participants

PRIMARY outcome

Timeframe: Up to approximately 28 months

Outcome measures

Outcome measures
Measure	Sitagliptin Phosphate (JANUVIA®) n=2974 Participants Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
Age of Participants Prescribed Sitagliptin	55 years Standard Deviation 12.2

PRIMARY outcome

Timeframe: Up to approximately 28 months

Outcome measures

Outcome measures
Measure	Sitagliptin Phosphate (JANUVIA®) n=2974 Participants Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
Number of Participants With Concomitant Therapies	1878 participants

PRIMARY outcome

Timeframe: Up to approximately 28 months

Outcome measures

Outcome measures
Measure	Sitagliptin Phosphate (JANUVIA®) n=2974 Participants Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
Number of Participants With Concomitant Conditions	752 participants

Adverse Events

Sitagliptin Phosphate (JANUVIA®)

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