Trial · NCT01703208
A Study to Assess Cardiovascular Outcomes Following Treatment With Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (MK-3102-018)
NCT01703208, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2017-12-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess Cardiovascular Outcomes Following Treatment With Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (MK-3102-018). Trials, record NCT01703208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01703208
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Cardiovascular Outcomes Following Treatment With Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (MK-3102-018)
- NCT number
- NCT01703208
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 4,202 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Omarigliptin, Placebo
- First posted
- 2012-10-10
- Last updated
- 2018-11-06
- Other registries' IDs
- eudract:2012-002414-39
- Results first posted
- 2017-12-12
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina) | Up to 156 weeks | Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction \[MI\], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015. |
| Primary | Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) | Up to 179 weeks | Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction \[MI\], and fatal and nonfatal stroke). |
| Primary | Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) | Up to 179 weeks | Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction \[MI\], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants' follow-up time to first event. |
| Primary | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 | Baseline and Week 18 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. |
| Primary | Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin) | Baseline and Week 18 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. |
| Primary | Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change | Up to Week 18 | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Primary | Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change | Up to Week 18 | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Secondary | Number of Participants With an Event of CV-Related Death | Up to 179 weeks | Participants with adjudicated and confirmed AEs of cardiovascular-related death. |
| Secondary | Number of Participants With an Event Per 100 Person-Years of CV-Related Death | Up to 179 weeks | Participants with adjudicated and confirmed AEs of cardiovascular-related death. Person-years were calculated as the sum of all participants' follow-up time to event. |
| Secondary | Number of Participants With an Event of First MI (Fatal and Non-fatal) | Up to 179 weeks | Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
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 MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina) | Up to 156 weeks | The analysis population included all randomized participants who took at least one dose of blinded study medication and were evaluated for MACE-plus events. | Participants | NUMBER |
| PRIMARY | Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) | Up to 179 weeks | The analysis population included all randomized participants who took at least one dose of blinded trial medication. | Participants | NUMBER |
| PRIMARY | Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) | Up to 179 weeks | The analysis population included all randomized participants who took at least one dose of blinded trial medication. | Participants/100 Person-years | NUMBER |
| PRIMARY | Change From Baseline in Hemoglobin A1C (A1C) at Week 18 | Baseline and Week 18 | The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement. | Percent | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin) | Baseline and Week 18 | The analysis population consists of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement. | Percentage | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change | Up to Week 18 | The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change | Up to Week 18 | The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With an Event of CV-Related Death | Up to 179 weeks | The analysis population consisted of all randomized participants who received at least one dose of blinded study medication. | Participants | NUMBER |
| SECONDARY | Number of Participants With an Event Per 100 Person-Years of CV-Related Death | Up to 179 weeks | The analysis population consisted of all participants who took at least one dose of blinded study medication. | Participants/100 person-years | NUMBER |
| SECONDARY | Number of Participants With an Event of First MI (Fatal and Non-fatal) | Up to 179 weeks | The analysis population consisted of all participants who took at least one dose of blinded study medication. | Participants | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group44
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 MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina) | Omarigliptin 25 mg | 66 | -1.14 to -0.90 | Participants | |
| Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina) | Placebo | 70 | -1.20 to -0.96 | Participants | |
| Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) | Omarigliptin 25 mg | 114 | -1.14 to -0.90 | Participants | |
| Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) | Placebo | 114 | -1.20 to -0.96 | Participants | |
| Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) | Omarigliptin 25 mg | 2.96 | -1.14 to -0.90 | Participants/100 Person-years | |
| Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) | Placebo | 2.97 | -1.20 to -0.96 | Participants/100 Person-years | |
| Change From Baseline in Hemoglobin A1C (A1C) at Week 18 | Omarigliptin 25 mg | -0.58 | 95% Confidence Interval 0.82 | Percent | |
| Change From Baseline in Hemoglobin A1C (A1C) at Week 18 | Placebo | -0.16 | 95% Confidence Interval 0.88 | Percent | |
| Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin) | Omarigliptin 25 mg | -0.50 | 95% Confidence Interval -0.57 to -0.42 | Percentage | |
| Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin) | Placebo | -0.11 | 95% Confidence Interval -0.19 to -0.03 | Percentage |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omarigliptin 25 mg | 2,100 | |
| Overall Study | STARTED | Placebo | 2,102 | |
| Overall Study | Treated | Omarigliptin 25 mg | 2,092 | |
| Overall Study | Treated | Placebo | 2,100 | |
| Overall Study | COMPLETED | Omarigliptin 25 mg | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Omarigliptin 25 mg | 2,100 | |
| Overall Study | NOT COMPLETED | Placebo | 2,102 |
Source ClinicalTrials.gov
Adverse events1,000
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 | Nasopharyngitis | Infections and infestations | Omarigliptin 25 mg | 123 | 2,092 | 167 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 145 | 2,100 | 195 |
| other | Upper respiratory tract infection | Infections and infestations | Omarigliptin 25 mg | 123 | 2,092 | 163 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 120 | 2,100 | 150 |
| other | Blood glucose increased | Investigations | Omarigliptin 25 mg | 97 | 2,092 | 139 |
| other | Blood glucose increased | Investigations | Placebo | 139 | 2,100 | 199 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Omarigliptin 25 mg | 530 | 2,092 | 3,990 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Placebo | 473 | 2,100 | 3,688 |
| other | Urinary tract infection | Infections and infestations | Omarigliptin 25 mg | 108 | 2,092 | 131 |
| other | Urinary tract infection | Infections and infestations | Placebo | 98 | 2,100 | 141 |
1 to 10 of 1,000Source ClinicalTrials.gov
See all 1,000 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omarigliptin 25 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Omarigliptin 25 mg | 788 | 2,092 |
| Total, other adverse events | Placebo | 794 | 2,100 |
| Total, serious adverse events | Omarigliptin 25 mg | 512 | 2,092 |
| Total, serious adverse events | Placebo | 503 | 2,100 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28893244 | RESULT |
Source PubMed
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Omarigliptin 25 mg vs Placebo: Number of Participants With an Event of Stroke (Fatal and Non-fatal) | Trial comparisons |
| Omarigliptin 25 mg vs Placebo: Number of Participants With an Event of CV-Related Death | Trial comparisons |
| Omarigliptin 25 mg vs Placebo: Number of Participants With an Event of All-Cause Death | Trial comparisons |
| Omarigliptin 25 mg vs Placebo: Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory) | Trial comparisons |
| Omarigliptin 25 mg vs Placebo: Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) | Trial comparisons |
| Omarigliptin 25 mg vs Placebo: Number of Participants With an Event of First MI (Fatal and Non-fatal) | Trial comparisons |
Omarigliptin 25 mg vs Placebo: Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina) | Trial comparisons |
| Omarigliptin 25 mg vs Placebo: serious adverse events | 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/NCT01703208
GET https://conductscience.org/api/trials/v1/NCT01703208/registered?page=2