Trial · NCT02692716
A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes
NCT02692716, Phase 3, Completed, Novo Nordisk A/S; results first posted 2020-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes. Trials, record NCT02692716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02692716
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes
- NCT number
- NCT02692716
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,183 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Interventions
- semaglutide, placebo
- First posted
- 2016-02-26
- Last updated
- 2022-07-20
- Other registries' IDs
- eudract:2015-003563-10
- Results first posted
- 2020-02-27
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke | Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Number of participants experiencing a first event of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment. |
| Secondary | Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure | Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Participants experiencing first occurrence of an expanded composite CV endpoint \[defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, UAP (unstable angina pectoris) requiring hospitalisation or heart failure requiring hospitalisation\] are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment. |
| Secondary | Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint | Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Participants experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospitalisation or heart failure requiring hospitalisation) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment. |
| Secondary | Time From Randomisation to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, Non-fatal Myocardial Infarction or Nonfatal Stroke | Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Participants experiencing first occurrence of a composite CV endpoint (defined as all-cause death, non-fatal myocardial infarction or nonfatal stroke) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment. |
| Secondary | Time From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial Infarction | Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Number of participants experiencing a first event of a fatal or non-fatal myocardial infarction are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment. |
| Secondary | Time From Randomisation to First Occurrence of Fatal or Non-fatal Stroke | Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Number of participants experiencing a first event of a fatal or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment. |
| Secondary | Time From Randomisation to All-cause Death | Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 5 weeks of follow-up period. | Number of all-cause deaths in the study are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment. |
| Secondary | Time to First AE Leading to Permanent Trial Product Discontinuation | Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window. | Number of participants who permanently discontinued trial product in ths study are presented. Results are based on the on-treatment observation period which starts at the date of first dose on trial product; ends on last date on trial product +38 days (ascertainment window). |
| Secondary | Number of Serious Adverse Events | Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window. | Number of serious adverse events were recorded from week 0 to week 87 in the study. Results are based on the on-treatment observation period which started at the date of first dose on trial product and ended on last date on trial product +38 days (ascertainment window). |
| Secondary | Change in Eye Examination Category | Week -3, End of treatment | Participants with eye examination findings, normal, abnormal non clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -3) and end of treatment visit (week 83) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment. |
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 | Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke | Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure | Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Overall number of participants analyzed = FAS which comprised all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint | Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Overall number of participants analyzed = FAS which comprised all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time From Randomisation to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, Non-fatal Myocardial Infarction or Nonfatal Stroke | Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Overall number of participants analyzed = FAS which comprised all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial Infarction | Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Overall number of participants analyzed = FAS which comprised all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time From Randomisation to First Occurrence of Fatal or Non-fatal Stroke | Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period. | Overall number of participants analyzed = FAS which comprised all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time From Randomisation to All-cause Death | Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 5 weeks of follow-up period. | Overall number of participants analyzed = FAS which comprised all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First AE Leading to Permanent Trial Product Discontinuation | Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window. | Overall number of participants analyzed = FAS which comprised all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Serious Adverse Events | Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window. | Overall number of participants analyzed = FAS which comprised all randomised participants. | Events | NUMBER |
| SECONDARY | Change in Eye Examination Category | Week -3, End of treatment | Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke | Oral Semaglutide | 61 | Participants | ||
| Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke | Placebo | 76 | Participants | ||
Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure | Oral Semaglutide | 83 | Participants | ||
Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure | Placebo | 100 | Participants | ||
| Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint | Oral Semaglutide | Cardiovascular death | 15 | Participants | |
| Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint | Placebo | Cardiovascular death | 30 | Participants | |
| Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint | Oral Semaglutide | Non-fatal myocardial infarction | 37 | Participants | |
| Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint | Placebo | Non-fatal myocardial infarction | 31 | Participants | |
| Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint | Oral Semaglutide | Non-fatal stroke | 12 | Participants | |
| Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint | Placebo | Non-fatal stroke | 16 | Participants |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Semaglutide | 1,591 | |
| Overall Study | STARTED | Placebo | 1,592 | |
| Overall Study | Full Analysis Set (FAS) | Oral Semaglutide | 1,591 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 1,592 | |
| Overall Study | Exposed | Oral Semaglutide | 1,591 | |
| Overall Study | Exposed | Placebo | 1,591 | |
| Overall Study | COMPLETED | Oral Semaglutide | 1,586 | |
| Overall Study | COMPLETED | Placebo | 1,586 | |
| Overall Study | NOT COMPLETED | Oral Semaglutide | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events840
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 | Abdominal pain | Gastrointestinal disorders | Oral Semaglutide | 2 | 1,591 | 2 |
| serious | Abdominal pain | Gastrointestinal disorders | Placebo | 2 | 1,591 | 2 |
| serious | Abdominal pain upper | Gastrointestinal disorders | Oral Semaglutide | 1 | 1,591 | 1 |
| serious | Abdominal pain upper | Gastrointestinal disorders | Placebo | 0 | 1,591 | 0 |
| serious | Abscess limb | Infections and infestations | Oral Semaglutide | 1 | 1,591 | 1 |
| serious | Abscess limb | Infections and infestations | Placebo | 0 | 1,591 | 0 |
| serious | Accidental overdose | Injury, poisoning and procedural complications | Oral Semaglutide | 1 | 1,591 | 1 |
| serious | Accidental overdose | Injury, poisoning and procedural complications | Placebo | 0 | 1,591 | 0 |
| serious | Acute coronary syndrome | Cardiac disorders | Oral Semaglutide | 1 | 1,591 | 1 |
| serious | Acute coronary syndrome | Cardiac disorders | Placebo | 0 | 1,591 | 0 |
1 to 10 of 840Source ClinicalTrials.gov
See all 840 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Semaglutide | 23 | 1,591 |
| Total, all-cause mortality | Placebo | 45 | 1,591 |
| Total, other adverse events | Oral Semaglutide | 0 | 1,591 |
| Total, other adverse events | Placebo | 0 | 1,591 |
| Total, serious adverse events | Oral Semaglutide | 301 | 1,591 |
| Total, serious adverse events | Placebo | 358 | 1,591 |
Source ClinicalTrials.gov
Papers14
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral Semaglutide vs Placebo: Time From Randomisation to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, Non-fatal Myocardial Infarction or Nonfatal Stroke | Trial comparisons |
Oral Semaglutide vs Placebo: Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure | Trial comparisons |
| Oral Semaglutide vs Placebo: Time to First AE Leading to Permanent Trial Product Discontinuation | Trial comparisons |
| Oral Semaglutide vs Placebo: Time From Randomisation to All-cause Death | Trial comparisons |
Oral Semaglutide vs Placebo: Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke | Trial comparisons |
| Oral Semaglutide vs Placebo: Time From Randomisation to First Occurrence of Fatal or Non-fatal Stroke | Trial comparisons |
| Oral Semaglutide vs Placebo: Time From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial Infarction | Trial comparisons |
| Oral Semaglutide vs Placebo: deaths from any cause | Trial comparisons |
| Oral Semaglutide 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/NCT02692716
GET https://conductscience.org/api/trials/v1/NCT02692716/results?page=2