Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02580591 | Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3) | PHASE3 | COMPLETED | 977 | — | — | Dec 22, 2015 | Sep 20, 2017 | Nov 2, 2018 | 189 | United States, Australia +22 |
| NCT02414958 | Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2) | PHASE3 | COMPLETED | 730 | — | — | Jun 30, 2015 | Oct 23, 2017 | Jan 3, 2019 | 131 | United States, Australia +15 |
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.
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.
Change from baseline in glycated haemoglobin (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 randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.
Change from baseline in glycated haemoglobin (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 randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.
| Arm | Type | Description |
|---|---|---|
| Empagliflozin low dose | EXPERIMENTAL | - |
| Empagliflozin high dose | EXPERIMENTAL | - |
| Empagliflozin medium dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Empagliflozin | DRUG | - |
| Placebo | DRUG | For blinding purposes |
Inclusion criteria: * Signed and dated written informed consent * Male or female patient receiving insulin for the treatment of documented diagnosis of type 1 diabetes mellitus (T1DM) \> 1 year * C-peptide value of \< 0.7 ng/mL * Use of Multiple Daily Injections (MDI) of insulin or insulin pump use...