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

Sitagliptin Phosphate/Metformin HCl (JANUMET®) Post Marketing Surveillance Protocol

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01357148
Enrollment
143
Registered
2011-05-20
Start date
2009-03-31
Completion date
2010-05-31
Last updated
2015-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

Interventions

DRUGSitagliptin Phosphate/Metformin HCl (JANUMET®)

Participants prescribed Sitagliptin Phosphate/Metformin HCl (JANUMET®) in routine clinical practice.

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of Participants With an Adverse EventUp to approximately 28 months
Age of Participants Prescribed Sitagliptin Phosphate/Metformin HClUp to approximately 28 months
Number of Participants With Concomitant ConditionsUp to approximately 28 months
Number of Participants Taking Concomitant MedicationsUp to approximately 28 months

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Sitagliptin Phosphate/Metformin HCl
Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
143
Total143

Baseline characteristics

CharacteristicSitagliptin Phosphate/Metformin HCl
Age, Continuous51 years
STANDARD_DEVIATION 13.2
Sex/Gender, Customized
Female
74 participants
Sex/Gender, Customized
Male
66 participants
Sex/Gender, Customized
Unspecified
3 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 143
serious
Total, serious adverse events
0 / 143

Outcome results

Primary

Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl

Time frame: Up to approximately 28 months

ArmMeasureValue (MEAN)Dispersion
Sitagliptin Phosphate/Metformin HClAge of Participants Prescribed Sitagliptin Phosphate/Metformin HCl51 yearsStandard Deviation 13.2
Primary

Number of Participants Taking Concomitant Medications

Time frame: Up to approximately 28 months

ArmMeasureValue (NUMBER)
Sitagliptin Phosphate/Metformin HClNumber of Participants Taking Concomitant Medications86 participants
Primary

Number of Participants With an Adverse Event

Time frame: Up to approximately 28 months

ArmMeasureValue (NUMBER)
Sitagliptin Phosphate/Metformin HClNumber of Participants With an Adverse Event6 participants
Primary

Number of Participants With Concomitant Conditions

Time frame: Up to approximately 28 months

ArmMeasureValue (NUMBER)
Sitagliptin Phosphate/Metformin HClNumber of Participants With Concomitant Conditions100 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026