Trial · NCT00790205
Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)
NCT00790205, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2016-04-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sitagliptin Cardiovascular Outcomes Study (MK-0431-082). Trials, record NCT00790205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00790205
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)
- NCT number
- NCT00790205
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 14,671 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Sitagliptin, Placebo
- First posted
- 2008-11-13
- Last updated
- 2021-11-23
- Other registries' IDs
- eudract:2008-006719-20
- Results first posted
- 2016-04-15
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) | Up to 5 years | Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization. |
| Primary | Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population) | Up to 5 years | Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization. |
| Secondary | Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population) | Up to 5 years | CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke. |
| Secondary | Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population) | Up to 5 years | CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke. |
| Secondary | Percent Incidence of All-cause Mortality (Per Protocol Population) | Up to 5 years | Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause. |
| Secondary | Percent Incidence of All-cause Mortality (Intent to Treat Population) | Up to 5 years | Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause. |
| Secondary | Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population) | Up to 5 years | Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF. |
| Secondary | Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population) | Up to 5 years | Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF. |
| Secondary | Change From Baseline in Renal Function Over Time (Per Protocol Population) | Baseline and up to 5 years | Change in renal function based on estimated glomerular filtration rate \[eGFR\] using the Modification of Diet in Renal Disease \[MDRD\] method. |
| Secondary | Change From Baseline in Renal Function Over Time (Intent to Treat Population) | Baseline and up to 5 years | Change in renal function based on eGFR using the MDRD method. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) | Up to 5 years | Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population) | Up to 5 years | Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population) | Up to 5 years | Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population) | Up to 5 years | Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. | Percentage of participants | NUMBER |
| SECONDARY | Percent Incidence of All-cause Mortality (Per Protocol Population) | Up to 5 years | Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. | Percentage of participants | NUMBER |
| SECONDARY | Percent Incidence of All-cause Mortality (Intent to Treat Population) | Up to 5 years | Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. | Percentage of participants | NUMBER |
| SECONDARY | Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population) | Up to 5 years | Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. | Percentage of participants | NUMBER |
| SECONDARY | Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population) | Up to 5 years | Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Renal Function Over Time (Per Protocol Population) | Baseline and up to 5 years | Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value. | mL/min/1.73 m^2 | MEAN |
| SECONDARY | Change From Baseline in Renal Function Over Time (Intent to Treat Population) | Baseline and up to 5 years | Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants with a baseline value. | mL/min/1.73 m^2 | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) | Sitagliptin | 9.6 | Percentage of participants | ||
| Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) | Placebo | 9.6 | Percentage of participants | ||
| Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population) | Sitagliptin | 11.4 | Percentage of participants | ||
| Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population) | Placebo | 11.6 | Percentage of participants | ||
| Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population) | Sitagliptin | 8.4 | Percentage of participants | ||
| Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population) | Placebo | 8.3 | Percentage of participants | ||
| Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population) | Sitagliptin | 10.2 | Percentage of participants | ||
| Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population) | Placebo | 10.2 | Percentage of participants | ||
| Percent Incidence of All-cause Mortality (Per Protocol Population) | Sitagliptin | 4.7 | Percentage of participants | ||
| Percent Incidence of All-cause Mortality (Per Protocol Population) | Placebo | 4.3 | Percentage of participants |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitagliptin | 7,332 | |
| Overall Study | STARTED | Placebo | 7,339 | |
| Overall Study | Treated | Sitagliptin | 7,266 | |
| Overall Study | Treated | Placebo | 7,274 | |
| Overall Study | COMPLETED | Sitagliptin | 6,972 | |
| Overall Study | COMPLETED | Placebo | 6,905 | |
| Overall Study | NOT COMPLETED | Sitagliptin | 360 | |
| Overall Study | NOT COMPLETED | Placebo | 434 |
Source ClinicalTrials.gov
Adverse events1,464
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Sitagliptin | 23 | 7,266 | 24 |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 23 | 7,274 | 23 |
| serious | Anaemia vitamin B12 deficiency | Blood and lymphatic system disorders | Sitagliptin | 1 | 7,266 | 1 |
| serious | Anaemia vitamin B12 deficiency | Blood and lymphatic system disorders | Placebo | 0 | 7,274 | 0 |
| serious | Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | Sitagliptin | 0 | 7,266 | 0 |
| serious | Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | Placebo | 1 | 7,274 | 1 |
| serious | Haemolytic anaemia | Blood and lymphatic system disorders | Sitagliptin | 1 | 7,266 | 1 |
| serious | Haemolytic anaemia | Blood and lymphatic system disorders | Placebo | 0 | 7,274 | 0 |
| serious | Haemorrhagic anaemia | Blood and lymphatic system disorders | Sitagliptin | 0 | 7,266 | 0 |
| serious | Haemorrhagic anaemia | Blood and lymphatic system disorders | Placebo | 1 | 7,274 | 1 |
1 to 10 of 1,464Source ClinicalTrials.gov
See all 1,464 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Sitagliptin | 0 | 7,266 |
| Total, other adverse events | Placebo | 0 | 7,274 |
| Total, serious adverse events | Sitagliptin | 928 | 7,266 |
| Total, serious adverse events | Placebo | 909 | 7,274 |
Source ClinicalTrials.gov
Papers19
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sitagliptin vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00790205
GET https://conductscience.org/api/trials/v1/NCT00790205/results?page=2