Trial · NCT02580591
Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
NCT02580591, Phase 3, Completed, Boehringer Ingelheim; results first posted 2018-11-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3). Trials, record NCT02580591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02580591
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
- NCT number
- NCT02580591
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 977 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Empagliflozin, Placebo
- First posted
- 2015-10-20
- Last updated
- 2018-11-02
- Other registries' IDs
- eudract:2014-005256-26
- Results first posted
- 2018-11-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) | Baseline to week 26 | Change from baseline in Glycated hemoglobin (HbA1c) for full analysis set (FAS) (observed cases \[OC\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline. |
| Primary | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD)) | Baseline to week 26 | Change from baseline in Glycated hemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data \[OC-AD\]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline. |
| Secondary | Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG) | Week 5 to Week 26, Week 1 to Week 26 | Rate per patient-year of investigator-reported symptomatic hypoglycemic adverse events (AEs) with confirmed plasma glucose (PG) \<54 milligram per deciliter (mg/dL) (\<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycemic AEs (i.e. all investigator-reported AEs that had confirmed PG \<54 mg/dL \[\<3.0 mmol/L\] with symptoms reported and all severe hypoglycemic events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate. This is key secondary endpoints. |
| Secondary | Change From Baseline in Body Weight at Week 26 | Baseline to week 26 | Change from baseline in body weight is presented With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline. |
| Secondary | Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26 | Baseline to week 26 | Change from baseline in Total daily insulin dose (TDID) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline. |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26 | Baseline to week 26 | Change from baseline in Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) | Baseline to week 26 | Full analysis set (FAS) (observed cases \[OC\]): Patients in the Treated Set (TS) who had a baseline and at least 1 on-treatment HbA1c measurement. | Percentage (%) | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD)) | Baseline to week 26 | Modified intention-to-treat set (mITT) (observed case - all data \[OC-AD\]): Patients in the TS who had a baseline and at least 1 post-baseline HbA1c measurement. | Percentage (%) | LEAST_SQUARES_MEAN |
| SECONDARY | Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG) | Week 5 to Week 26, Week 1 to Week 26 | FAS (OC) | Events per patient year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at Week 26 | Baseline to week 26 | FAS (OC) | Kilogram (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26 | Baseline to week 26 | FAS (OC) | Unit/kilogram (U/kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26 | Baseline to week 26 | FAS observed cases excluding data after change in use of anti-hypertensives (OC-H) | Millimeters of mercury (mmHg) | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) | Placebo Matching Empagliflozin | 0.20 | Standard Error 0.05 | Percentage (%) | |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) | Empagliflozin 2.5 Milligram (mg) | -0.09 | Standard Error 0.05 | Percentage (%) | |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) | Empagliflozin 10 mg | -0.25 | Standard Error 0.05 | Percentage (%) | |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC]) | Empagliflozin 25 mg | -0.33 | Standard Error 0.05 | Percentage (%) | |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD)) | Placebo Matching Empagliflozin | 0.21 | Standard Error 0.05 | Percentage (%) | |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD)) | Empagliflozin 2.5 Milligram (mg) | -0.06 | Standard Error 0.05 | Percentage (%) | |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD)) | Empagliflozin 10 mg | -0.23 | Standard Error 0.05 | Percentage (%) | |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD)) | Empagliflozin 25 mg | -0.30 | Standard Error 0.05 | Percentage (%) | |
| Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG) | Placebo Matching Empagliflozin | Week 5 to 26 | 6.13 | 95% Confidence Interval 4.83 to 7.78 | Events per patient year |
| Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG) | Empagliflozin 2.5 Milligram (mg) | Week 5 to 26 | 5.77 | 95% Confidence Interval 4.53 to 7.34 | Events per patient year |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Matching Empagliflozin | 242 | |
| Overall Study | STARTED | Empagliflozin 2.5 Milligram (mg) | 242 | |
| Overall Study | STARTED | Empagliflozin 10 mg | 248 | |
| Overall Study | STARTED | Empagliflozin 25 mg | 245 | |
| Overall Study | Treated | Placebo Matching Empagliflozin | 241 | |
| Overall Study | Treated | Empagliflozin 2.5 Milligram (mg) | 241 | |
| Overall Study | Treated | Empagliflozin 10 mg | 248 | |
| Overall Study | Treated | Empagliflozin 25 mg | 245 | |
| Overall Study | COMPLETED | Placebo Matching Empagliflozin | 224 | |
| Overall Study | COMPLETED | Empagliflozin 2.5 Milligram (mg) | 232 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events236
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 | Placebo Matching Empagliflozin | 24 | 241 | |
| other | Nasopharyngitis | Infections and infestations | Empagliflozin 2.5 Milligram (mg) | 23 | 241 | |
| other | Nasopharyngitis | Infections and infestations | Empagliflozin 10 mg | 22 | 248 | |
| other | Nasopharyngitis | Infections and infestations | Empagliflozin 25 mg | 26 | 245 | |
| other | Urinary tract infection | Infections and infestations | Placebo Matching Empagliflozin | 12 | 241 | |
| other | Urinary tract infection | Infections and infestations | Empagliflozin 2.5 Milligram (mg) | 12 | 241 | |
| other | Urinary tract infection | Infections and infestations | Empagliflozin 10 mg | 9 | 248 | |
| other | Urinary tract infection | Infections and infestations | Empagliflozin 25 mg | 16 | 245 | |
| other | Blood ketone body increased | Investigations | Placebo Matching Empagliflozin | 3 | 241 | |
| other | Blood ketone body increased | Investigations | Empagliflozin 2.5 Milligram (mg) | 4 | 241 |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Matching Empagliflozin | 0 | 241 |
| Total, all-cause mortality | Empagliflozin 2.5 Milligram (mg) | 0 | 241 |
| Total, all-cause mortality | Empagliflozin 10 mg | 0 | 248 |
| Total, all-cause mortality | Empagliflozin 25 mg | 1 | 245 |
| Total, other adverse events | Placebo Matching Empagliflozin | 153 | 241 |
| Total, other adverse events | Empagliflozin 2.5 Milligram (mg) | 146 | 241 |
| Total, other adverse events | Empagliflozin 10 mg | 172 | 248 |
| Total, other adverse events | Empagliflozin 25 mg | 162 | 245 |
| Total, serious adverse events | Placebo Matching Empagliflozin | 16 | 241 |
| Total, serious adverse events | Empagliflozin 2.5 Milligram (mg) | 13 | 241 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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.
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/NCT02580591
GET https://conductscience.org/api/trials/v1/NCT02580591/results?page=2