Trial · NCT01986881
Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004)
NCT01986881, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2021-02-15
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ConductScience Library. Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004). Trials, record NCT01986881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01986881
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004)
- NCT number
- NCT01986881
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 8,246 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Ertugliflozin, Placebo, Glycemic Rescue
- First posted
- 2013-11-19
- Last updated
- 2022-09-23
- Other registries' IDs
- eudract:2013-002518-11
- Results first posted
- 2021-02-15
Source ClinicalTrials.gov
Registered outcomes126
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke. The on-treatment approach included confirmed events that occurred between the date of first dose of study medication and the on-treatment censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, last contact date, or 365 days after the last dose). |
| Primary | Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Baseline | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C. |
| Primary | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Baseline and Week 18 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Primary | Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Baseline | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C. |
| Primary | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Baseline and Week 18 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Primary | Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Baseline | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects Week 0 A1C. |
| Primary | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Baseline and Week 18 | A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. |
| Secondary | Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Time to the occurrence of any of the following adjudicated components of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)) or hospitalization for heart failure. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). |
| Secondary | Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Time to the occurrence of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to CV death or time to censoring (the earliest of participants' end of study date or date last known to be alive). |
| Secondary | Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | Renal composite endpoint was defined as a composite of renal death, renal dialysis/transplant, or doubling of serum creatinine from baseline. The on-study approach included events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date. |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 registered outcomesOutcomes126
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | The analysis population included all participants who were randomized into the study and who received at least 1 dose of study medication. | Events per 100 Person-years | NUMBER |
| PRIMARY | Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Baseline | The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and had a measurement of the analysis endpoint at Baseline. | A1C Percentage | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Baseline and Week 18 | The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least 1 dose of study medication, and had at least 1 measurement of the analysis endpoint for the specified timepoint(s) from Baseline to Week 18. | A1C Percentage | LEAST_SQUARES_MEAN |
| PRIMARY | Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Baseline | The analysis population included all participants who were randomized, participated in the Sulfonyl Monotherapy Glycemic Sub-study, and had a measurement of the analysis endpoint at Baseline. | A1C Percentage | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) | Baseline and Week 18 | The analysis population included all participants who were randomized, participated in the Sulfonyl Monotherapy Glycemic Sub-study, received at least 1 dose of study medication, and had at least 1 measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18. | A1C Percentage | LEAST_SQUARES_MEAN |
| PRIMARY | Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Baseline | The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, and had an assessment for the analysis endpoint at Baseline. | A1C Percentage | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study) | Baseline and Week 18 | The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after Baseline. | A1C Percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | The analysis population included all randomized participants. | Events per 100 Person-years | NUMBER |
| SECONDARY | Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | The analysis population included all randomized participants. | Events per 100 Person-years | NUMBER |
| SECONDARY | Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study) | Up to approximately 6 years | The analysis population included all randomized participants. | Events per 100 Person-years | NUMBER |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 outcomesResults by group408
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study) | Ertugliflozin 5 mg (Overall Cardiovascular Study) | 3.64 | Events per 100 Person-years | ||
Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study) | Ertugliflozin 15 mg (Overall Cardiovascular Study) | 4.16 | Events per 100 Person-years | ||
Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study) | Placebo (Overall Cardiovascular Study) | 4.01 | Events per 100 Person-years | ||
Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study) | All Ertugliflozin (Overall Cardiovascular Study) | 3.90 | Events per 100 Person-years | ||
| Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Ertugliflozin 5 mg (Insulin +/- Metformin Glycemic Sub-study) | 8.45 | Standard Deviation 0.944 | A1C Percentage | |
| Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Ertugliflozin 15 mg (Insulin +/- Metformin Glycemic Sub-study) | 8.38 | Standard Deviation 0.985 | A1C Percentage | |
| Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Placebo (Ins+/-Met Sub-study) | 8.39 | Standard Deviation 0.928 | A1C Percentage | |
| Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Ertugliflozin 5 mg (Insulin +/- Metformin Glycemic Sub-study) | -0.77 | 95% Confidence Interval -0.86 to -0.67 | A1C Percentage | |
| Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Ertugliflozin 15 mg (Insulin +/- Metformin Glycemic Sub-study) | -0.84 | 95% Confidence Interval -0.93 to -0.74 | A1C Percentage | |
| Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study) | Placebo (Ins+/-Met Sub-study) | -0.19 | 95% Confidence Interval -0.29 to -0.09 | A1C Percentage |
1 to 10 of 408Source ClinicalTrials.gov
See all 408 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ertugliflozin 5 mg (Overall Cardiovascular Study) | 2,752 | |
| Overall Study | STARTED | Ertugliflozin 15 mg (Overall Cardiovascular Study) | 2,747 | |
| Overall Study | STARTED | Placebo (Overall Cardiovascular Study) | 2,747 | |
| Overall Study | Treated | Ertugliflozin 5 mg (Overall Cardiovascular Study) | 2,746 | |
| Overall Study | Treated | Ertugliflozin 15 mg (Overall Cardiovascular Study) | 2,747 | |
| Overall Study | Treated | Placebo (Overall Cardiovascular Study) | 2,745 | |
| Overall Study | Participants Enrolled in the Insulin +/- Metformin Glycemic Sub-Study | Ertugliflozin 5 mg (Overall Cardiovascular Study) | 348 | |
| Overall Study | Participants Enrolled in the Insulin +/- Metformin Glycemic Sub-Study | Ertugliflozin 15 mg (Overall Cardiovascular Study) | 370 | |
| Overall Study | Participants Enrolled in the Insulin +/- Metformin Glycemic Sub-Study | Placebo (Overall Cardiovascular Study) | 347 | |
| Overall Study | Participants Enrolled in the Sulfonylurea Monotherapy Glycemic Sub-Study | Ertugliflozin 5 mg (Overall Cardiovascular Study) | 55 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events12,144
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 |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Ertugliflozin 5 mg (Overall Cardiovascular Study) | 132 | 2,746 | 163 |
| other | Diarrhoea | Gastrointestinal disorders | Ertugliflozin 15 mg (Overall Cardiovascular Study) | 138 | 2,747 | 161 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (Overall Cardiovascular Study) | 126 | 2,745 | 153 |
| other | Diarrhoea | Gastrointestinal disorders | Ertugliflozin 5 mg (Insulin +/- Metformin Sub-study) | 7 | 348 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Ertugliflozin 15 mg (Insulin +/- Metformin Glycemic Sub-study) | 9 | 370 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (Insulin +/- Metformin Glycemic Sub-study) | 8 | 347 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Ertugliflozin 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) | 0 | 55 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Ertugliflozin 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) | 0 | 54 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study) | 1 | 48 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Ertugliflozin 5 mg (Metformin With Sulfonylurea Glycemic Sub-study) | 2 | 100 | 2 |
1 to 10 of 12,144Source ClinicalTrials.gov
See all 12,144 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ertugliflozin 5 mg (Overall Cardiovascular Study) | 228 | 2,746 |
| Total, all-cause mortality | Ertugliflozin 15 mg (Overall Cardiovascular Study) | 233 | 2,747 |
| Total, all-cause mortality | Placebo (Overall Cardiovascular Study) | 247 | 2,745 |
| Total, all-cause mortality | Ertugliflozin 5 mg (Insulin +/- Metformin Sub-study) | 4 | 348 |
| Total, all-cause mortality | Ertugliflozin 15 mg (Insulin +/- Metformin Glycemic Sub-study) | 6 | 370 |
| Total, all-cause mortality | Placebo (Insulin +/- Metformin Glycemic Sub-study) | 1 | 347 |
| Total, all-cause mortality | Ertugliflozin 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) | 0 | 55 |
| Total, all-cause mortality | Ertugliflozin 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) | 1 | 54 |
| Total, all-cause mortality | Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study) | 0 | 48 |
| Total, all-cause mortality | Ertugliflozin 5 mg (Metformin With Sulfonylurea Glycemic Sub-study) | 0 | 100 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers17
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 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.
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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.
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