Trial · NCT01243424
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes
NCT01243424, Phase 3, Completed, Boehringer Ingelheim; results first posted 2020-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes. Trials, record NCT01243424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01243424
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes
- NCT number
- NCT01243424
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 6,103 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- linagliptin, glimepiride, linagliptin placebo, glimepiride placebo
- First posted
- 2010-11-18
- Last updated
- 2020-01-07
- Other registries' IDs
- eudract:2009-013157-15
- Results first posted
- 2020-01-07
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The First 3-point Major Adverse Cardiovascular Events (3P-MACE) | From randomization until individual day of trial completion, up to 432 weeks | The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented. |
| Secondary | The First 4-point (4P)- MACE | From randomization until individual day of trial completion, up to 432 weeks | The first key secondary endpoint was time to first occurrence of any of the following adjudicated components of the composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal stroke, non-fatal MI (excluding silent MI), or hospitalisation for unstable angina pectoris. |
| Secondary | Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase | From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase) | The second key secondary endpoint was a composite endpoint of treatment sustainability, defined as the percentage of patients taking trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, without \>2% weight gain, and without moderate/severe hypoglycaemic episodes during maintenance phase. |
| Secondary | Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase | From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase) | The third key secondary endpoint was a composite endpoint of treatment sustainability, defined as percentage of patients who were on trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, and without \>2% weight gain during maintenance phase. |
| Secondary | Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE | From randomization until individual day of trial completion, up to 432 weeks | Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) and non-fatal stroke is presented as secondary CV endpoint. |
| Secondary | Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE | From randomization until individual day of trial completion, up to 432 weeks | Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), non-fatal stroke, and hospitalisation for unstable angina pectoris is presented as secondary CV endpoint. |
| Secondary | Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events | From start of the treatment until 7 days after the end of treatment, up to 433 weeks | Percentage of participants with occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of: * CV death (including fatal stroke and fatal MI) * non-fatal MI * non-fatal stroke * hospitalisation for unstable angina pectoris * TIA * hospitalisation for heart failure * hospitalisation for coronary revascularisation procedures (CABG, PCI) |
| Secondary | Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events | From start of the treatment until 7 days after the end of treatment, up to 433 weeks | Time to first occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of: * CV death (including fatal stroke and fatal MI) * non-fatal MI * non-fatal stroke * hospitalisation for unstable angina pectoris * Transient ischaemic attack (TIA) * hospitalisation for heart failure * hospitalisation for coronary revascularisation procedures (CABG, PCI) |
| Secondary | Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c) | Baseline and week 432 | Change from baseline to final visit in HbA1c is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. |
| Secondary | Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG) | Baseline and week 432 | Change from baseline to final visit in fasting plasma glucose (FPG) is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The First 3-point Major Adverse Cardiovascular Events (3P-MACE) | From randomization until individual day of trial completion, up to 432 weeks | Treated set (TS): All patients treated with at least one dose of trial drug. | Events/ 1000 patients-years | NUMBER |
| SECONDARY | The First 4-point (4P)- MACE | From randomization until individual day of trial completion, up to 432 weeks | TS | Events/ 1000 patients-years | NUMBER |
| SECONDARY | Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase | From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase) | TS without duplicates (TS w/o duplicates), patients who are off-drug or died prior to regular study stop were handled as non-completers considered failure (NCF). | Percentage of participants (%) | NUMBER |
| SECONDARY | Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase | From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase) | TS w/o duplicates (NCF) | Percentage of participants (%) | NUMBER |
| SECONDARY | Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE | From randomization until individual day of trial completion, up to 432 weeks | TS | Percentage of participants (%) | NUMBER |
| SECONDARY | Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE | From randomization until individual day of trial completion, up to 432 weeks | TS | Percentage of participants (%) | NUMBER |
| SECONDARY | Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events | From start of the treatment until 7 days after the end of treatment, up to 433 weeks | TS | Percentage of participants (%) | NUMBER |
| SECONDARY | Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events | From start of the treatment until 7 days after the end of treatment, up to 433 weeks | TS | Events/ 1000 patients-years | NUMBER |
| SECONDARY | Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c) | Baseline and week 432 | TS w/o duplicates considering all available data | Percentage glycosylated hemoglobin (%) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG) | Baseline and week 432 | TS w/o duplicates considering all available data | Milligram/ deciliter (mg/dL) | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The First 3-point Major Adverse Cardiovascular Events (3P-MACE) | Linagliptin | 20.7 | Events/ 1000 patients-years | ||
| The First 3-point Major Adverse Cardiovascular Events (3P-MACE) | Glimepiride | 21.2 | Events/ 1000 patients-years | ||
| The First 4-point (4P)- MACE | Linagliptin | 23.4 | Events/ 1000 patients-years | ||
| The First 4-point (4P)- MACE | Glimepiride | 23.7 | Events/ 1000 patients-years | ||
Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase | Linagliptin | 16.0 | 95% Confidence Interval 14.7 to 17.3 | Percentage of participants (%) | |
Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase | Glimepiride | 10.2 | 95% Confidence Interval 9.1 to 11.3 | Percentage of participants (%) | |
Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase | Linagliptin | 17.4 | 95% Confidence Interval 16.1 to 18.8 | Percentage of participants (%) | |
Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase | Glimepiride | 14.1 | 95% Confidence Interval 12.9 to 15.4 | Percentage of participants (%) | |
| Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE | Linagliptin | 11.8 | 95% Confidence Interval 10.7 to 13.0 | Percentage of participants (%) | |
| Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE | Glimepiride | 12.0 | 95% Confidence Interval 10.9 to 13.2 | Percentage of participants (%) |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Discontinuation From Study (Treated Set) | STARTED | Linagliptin | 3,028 | |
| Discontinuation From Study (Treated Set) | STARTED | Glimepiride | 3,014 | |
| Discontinuation From Study (Treated Set) | Patient Died (Other Cause Than CV Death) | Linagliptin | 123 | |
| Discontinuation From Study (Treated Set) | Patient Died (Other Cause Than CV Death) | Glimepiride | 146 | |
| Discontinuation From Study (Treated Set) | Treated | Linagliptin | 3,023 | |
| Discontinuation From Study (Treated Set) | Treated | Glimepiride | 3,010 | |
| Discontinuation From Study (Treated Set) | COMPLETED | Linagliptin | 2,899 | |
| Discontinuation From Study (Treated Set) | COMPLETED | Glimepiride | 2,895 | |
| Discontinuation From Study (Treated Set) | NOT COMPLETED | Linagliptin | 129 | |
| Discontinuation From Study (Treated Set) | NOT COMPLETED | Glimepiride | 119 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events2,714
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 | Anaemia | Blood and lymphatic system disorders | Linagliptin | 208 | 3,023 | |
| other | Anaemia | Blood and lymphatic system disorders | Glimepiride | 178 | 3,010 | |
| other | Cataract | Eye disorders | Linagliptin | 219 | 3,023 | |
| other | Cataract | Eye disorders | Glimepiride | 203 | 3,010 | |
| other | Constipation | Gastrointestinal disorders | Linagliptin | 195 | 3,023 | |
| other | Constipation | Gastrointestinal disorders | Glimepiride | 173 | 3,010 | |
| other | Diarrhoea | Gastrointestinal disorders | Linagliptin | 365 | 3,023 | |
| other | Diarrhoea | Gastrointestinal disorders | Glimepiride | 324 | 3,010 | |
| other | Nausea | Gastrointestinal disorders | Linagliptin | 157 | 3,023 | |
| other | Nausea | Gastrointestinal disorders | Glimepiride | 164 | 3,010 |
1 to 10 of 2,714Source ClinicalTrials.gov
See all 2,714 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Linagliptin | 308 | 3,023 |
| Total, all-cause mortality | Glimepiride | 336 | 3,010 |
| Total, other adverse events | Linagliptin | 2,376 | 3,023 |
| Total, other adverse events | Glimepiride | 2,504 | 3,010 |
| Total, serious adverse events | Linagliptin | 1,403 | 3,023 |
| Total, serious adverse events | Glimepiride | 1,448 | 3,010 |
Source ClinicalTrials.gov
Papers11
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 |
|---|---|
| Linagliptin vs Glimepiride: deaths from any cause | Trial comparisons |
| Linagliptin vs Glimepiride: 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/NCT01243424
GET https://conductscience.org/api/trials/v1/NCT01243424/results?page=2