Diabetes Mellitus, Type 2
Conditions
Brief summary
The primary objective of this study is to obtain safety information on the use of sitagliptin (JANUVIA®) from endocrinologists, diabetologists, internists, and general practitioners.
Interventions
Participants prescribed Sitagliptin (JANUVIA®) in routine clinical practice.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- Must be taking sitagliptin (JANUVIA™) for the treatment of type 2 diabetes mellitus \- Treating physician must agree to provide information regarding the participants treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With an Adverse Event | Up to approximately 28 months |
| Age of Participants Prescribed Sitagliptin | Up to approximately 28 months |
| Number of Participants With Concomitant Therapies | Up to approximately 28 months |
| Number of Participants With Concomitant Conditions | Up to approximately 28 months |
Participant flow
Recruitment details
This was a postmarketing, safety study of participants with Type 2 diabetes mellitus prescribed sitagliptin phosphate (JUNUVIA®) in clinical practices in the Philippines.
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin Phosphate (JANUVIA®) Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice. | 2,974 |
| Total | 2,974 |
Baseline characteristics
| Characteristic | Sitagliptin Phosphate (JANUVIA®) |
|---|---|
| Age, Customized 0 - 19 | 0 participants 12.2 |
| Age, Customized 20 - 99 | 2926 participants |
| Age, Customized Unspecified | 48 participants |
| Sex/Gender, Customized Female | 1577 participants |
| Sex/Gender, Customized Male | 1351 participants |
| Sex/Gender, Customized Unspecified | 46 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2,974 |
| serious Total, serious adverse events | 0 / 2,974 |
Outcome results
Primary
Age of Participants Prescribed Sitagliptin
Time frame: Up to approximately 28 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin Phosphate (JANUVIA®) | Age of Participants Prescribed Sitagliptin | 55 years | Standard Deviation 12.2 |
Primary
Number of Participants With an Adverse Event
Time frame: Up to approximately 28 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin Phosphate (JANUVIA®) | Number of Participants With an Adverse Event | 25 participants |
Primary
Number of Participants With Concomitant Conditions
Time frame: Up to approximately 28 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin Phosphate (JANUVIA®) | Number of Participants With Concomitant Conditions | 752 participants |
Primary
Number of Participants With Concomitant Therapies
Time frame: Up to approximately 28 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin Phosphate (JANUVIA®) | Number of Participants With Concomitant Therapies | 1878 participants |