Trial · NCT01959529
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
NCT01959529, Phase 3, Completed, Novo Nordisk A/S; results first posted 2017-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events. Trials, record NCT01959529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01959529
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
- NCT number
- NCT01959529
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7,637 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Interventions
- insulin degludec, insulin glargine
- First posted
- 2013-10-10
- Last updated
- 2019-07-24
- Other registries' IDs
- eudract:2013-002371-17
- Results first posted
- 2017-11-17
Source ClinicalTrials.gov
Registered outcomes4
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): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke | From randomisation to individual end of trial date (maximum patient year observation: 2.75 years) | Time from randomisation to first occurrence of an event adjudication committee (EAC)-confirmed 3-component major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke. Events with EAC-confirmed onset date between randomisation and individual end of trial were included in the analyses. The number of subjects experiencing first EAC-confirmed MACEs, date between randomisation to the end of trial, both days included were presented. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months. |
| Secondary | Number of EAC-confirmed Severe Hypoglycaemic Episodes | From randomisation to individual end of trial (maximum patient year observation: 2.75 years) | Number of severe hypoglycaemic episodes from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months. |
| Secondary | Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no) | From randomisation to individual end of trial date (maximum patient year observation: 2.75 years) | Occurrence of at least one EAC-confirmed severe hypoglycaemic episode within a subject from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. |
| Secondary | Change in Glycosylated Haemoglobin (HbA1c) | Randomisation to 24 months | Mean change in HbA1c from week 0 to month 24. |
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 | Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke | From randomisation to individual end of trial date (maximum patient year observation: 2.75 years) | The analysis was based on the FAS, which included all randomised subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of EAC-confirmed Severe Hypoglycaemic Episodes | From randomisation to individual end of trial (maximum patient year observation: 2.75 years) | The analysis was based on the FAS, which included all randomised subjects. | Number of severe episodes | NUMBER |
| SECONDARY | Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no) | From randomisation to individual end of trial date (maximum patient year observation: 2.75 years) | The analysis was based on the FAS, which included all randomised subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Glycosylated Haemoglobin (HbA1c) | Randomisation to 24 months | The analysis was based on the FAS. The number of subjects analysed are the number of subjects with the available data after 24 months. | percentage of HbA1c | MEAN |
Source ClinicalTrials.gov
Results by group14
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): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke | Insulin Degludec | First EAC-confirmed MACE | 325 | Participants | |
| Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke | Insulin Glargine | First EAC-confirmed MACE | 356 | Participants | |
| Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke | Insulin Degludec | Myocardial infarction (non-fatal) | 143 | Participants | |
| Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke | Insulin Glargine | Myocardial infarction (non-fatal) | 163 | Participants | |
| Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke | Insulin Degludec | Stroke (non-fatal) | 68 | Participants | |
| Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke | Insulin Glargine | Stroke (non-fatal) | 74 | Participants | |
| Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke | Insulin Degludec | Cardiovascular death | 114 | Participants | |
| Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke | Insulin Glargine | Cardiovascular death | 119 | Participants | |
| Number of EAC-confirmed Severe Hypoglycaemic Episodes | Insulin Degludec | 280 | Number of severe episodes | ||
| Number of EAC-confirmed Severe Hypoglycaemic Episodes | Insulin Glargine | 472 | Number of severe episodes |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Insulin Degludec | 3,818 | |
| Overall Study | STARTED | Insulin Glargine | 3,819 | |
| Overall Study | Exposed | Insulin Degludec | 3,809 | |
| Overall Study | Exposed | Insulin Glargine | 3,806 | |
| Overall Study | COMPLETED | Insulin Degludec | 3,742 | |
| Overall Study | COMPLETED | Insulin Glargine | 3,747 | |
| Overall Study | NOT COMPLETED | Insulin Degludec | 76 | |
| Overall Study | NOT COMPLETED | Insulin Glargine | 72 |
Source ClinicalTrials.gov
Adverse events2,182
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 abscess | Infections and infestations | Insulin Degludec | 0 | 3,818 | 0 |
| serious | Abdominal abscess | Infections and infestations | Insulin Glargine | 1 | 3,819 | 1 |
| serious | Abdominal discomfort | Gastrointestinal disorders | Insulin Degludec | 0 | 3,818 | 0 |
| serious | Abdominal discomfort | Gastrointestinal disorders | Insulin Glargine | 1 | 3,819 | 1 |
| serious | Abdominal hernia | Gastrointestinal disorders | Insulin Degludec | 1 | 3,818 | 1 |
| serious | Abdominal hernia | Gastrointestinal disorders | Insulin Glargine | 1 | 3,819 | 1 |
| serious | Abdominal hernia obstructive | Gastrointestinal disorders | Insulin Degludec | 0 | 3,818 | 0 |
| serious | Abdominal hernia obstructive | Gastrointestinal disorders | Insulin Glargine | 2 | 3,819 | 2 |
| serious | Abdominal hernia repair | Surgical and medical procedures | Insulin Degludec | 0 | 3,818 | 0 |
| serious | Abdominal hernia repair | Surgical and medical procedures | Insulin Glargine | 1 | 3,819 | 1 |
1 to 10 of 2,182Source ClinicalTrials.gov
See all 2,182 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Insulin Degludec | ||
| Total, all-cause mortality | Insulin Glargine | ||
| Total, other adverse events | Insulin Degludec | 0 | 3,818 |
| Total, other adverse events | Insulin Glargine | 0 | 3,819 |
| Total, serious adverse events | Insulin Degludec | 1,473 | 3,818 |
| Total, serious adverse events | Insulin Glargine | 1,517 | 3,819 |
Source ClinicalTrials.gov
Papers15
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Insulin Degludec vs Insulin Glargine: Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no) | Trial comparisons |
| Insulin Degludec vs Insulin Glargine: 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/NCT01959529
GET https://conductscience.org/api/trials/v1/NCT01959529/events?page=2