An observational study in Diabetes Mellitus, Type 2, sponsored by Merck Sharp & Dohme LLC. Completed. Per ClinicalTrials.gov, last updated 2015-08-27.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Observational
The primary objective of this study is to obtain safety information on the use of sitagliptin (JANUVIA®) from endocrinologists, diabetologists, internists, and general practitioners.
9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.
This study's enrollment of 2,974 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with type 2 diabetes mellitus who are treated with sitagliptin as per the standard of care in a physician's practice
Inclusion Criteria:
mellitus
Drug: Sitagliptin (JANUVIA®)
Participants prescribed Sitagliptin (JANUVIA®) in routine clinical practice.
Number of Participants With an Adverse Event
Time frame: Up to approximately 28 months
Age of Participants Prescribed Sitagliptin
Time frame: Up to approximately 28 months
Number of Participants With Concomitant Therapies
Time frame: Up to approximately 28 months
Number of Participants With Concomitant Conditions
Time frame: Up to approximately 28 months
This was a postmarketing, safety study of participants with Type 2 diabetes mellitus prescribed sitagliptin phosphate (JUNUVIA®) in clinical practices in the Philippines.
| Milestone | Sitagliptin Phosphate (JANUVIA®) |
|---|---|
| Started | 2974 |
| Completed | 2974 |
| Not completed | 0 |
| participants | Sitagliptin Phosphate (JANUVIA®) |
|---|---|
| Number of Participants With an Adverse Event | 25 |
| years | Sitagliptin Phosphate (JANUVIA®) |
|---|---|
| Age of Participants Prescribed Sitagliptin | 55 ± 12.2 |
| participants | Sitagliptin Phosphate (JANUVIA®) |
|---|---|
| Number of Participants With Concomitant Therapies | 1878 |
| participants | Sitagliptin Phosphate (JANUVIA®) |
|---|---|
| Number of Participants With Concomitant Conditions | 752 |
Collected over Up to approximately 28 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sitagliptin Phosphate (JANUVIA®) | — | 0/2,974 (0%) | 0/2,974 (0%) |
| Age, Customized(participants) | Sitagliptin Phosphate (JANUVIA®) |
|---|---|
| 0 - 19 | 0 ± 12.2 |
| 20 - 99 | 2926 |
| Unspecified | 48 |
| Sex/Gender, Customized(participants) | Sitagliptin Phosphate (JANUVIA®) |
|---|---|
| Female | 1577 |
| Male | 1351 |
| Unspecified | 46 |
No study locations are listed for this record.
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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