Trial · NCT01354990
A Post Marketing Safety Study of Sitagliptin (JANUVIA®) (MK-0431-234)
NCT01354990, Completed, Merck Sharp & Dohme LLC; results first posted 2012-06-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Post Marketing Safety Study of Sitagliptin (JANUVIA®) (MK-0431-234). Trials, record NCT01354990. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01354990
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Post Marketing Safety Study of Sitagliptin (JANUVIA®) (MK-0431-234)
- NCT number
- NCT01354990
- Status
- Completed
- Enrollment
- 2,974 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Sitagliptin (JANUVIA®)
- First posted
- 2011-05-17
- Last updated
- 2015-08-27
- Results first posted
- 2012-06-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With an Adverse Event | Up to approximately 28 months | |
| Primary | Age of Participants Prescribed Sitagliptin | Up to approximately 28 months | |
| Primary | Number of Participants With Concomitant Therapies | Up to approximately 28 months | |
| Primary | Number of Participants With Concomitant Conditions | Up to approximately 28 months |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With an Adverse Event | Up to approximately 28 months | participants | NUMBER | |
| PRIMARY | Age of Participants Prescribed Sitagliptin | Up to approximately 28 months | years | MEAN | |
| PRIMARY | Number of Participants With Concomitant Therapies | Up to approximately 28 months | participants | NUMBER | |
| PRIMARY | Number of Participants With Concomitant Conditions | Up to approximately 28 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With an Adverse Event | Sitagliptin Phosphate (JANUVIA®) | 25 | participants | ||
| Age of Participants Prescribed Sitagliptin | Sitagliptin Phosphate (JANUVIA®) | 55 | Standard Deviation 12.2 | years | |
| Number of Participants With Concomitant Therapies | Sitagliptin Phosphate (JANUVIA®) | 1878 | participants | ||
| Number of Participants With Concomitant Conditions | Sitagliptin Phosphate (JANUVIA®) | 752 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitagliptin Phosphate (JANUVIA®) | 2,974 | |
| Overall Study | COMPLETED | Sitagliptin Phosphate (JANUVIA®) | 2,974 | |
| Overall Study | NOT COMPLETED | Sitagliptin Phosphate (JANUVIA®) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin Phosphate (JANUVIA®) | ||
| Total, other adverse events | Sitagliptin Phosphate (JANUVIA®) | 0 | 2,974 |
| Total, serious adverse events | Sitagliptin Phosphate (JANUVIA®) | 0 | 2,974 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01354990
GET https://conductscience.org/api/trials/v1/NCT01354990/registered