Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
empagliflozin medium dose · 6 trials · 3 indications
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.
Change from baseline in HbA1c (%) at 24 weeks is presented. The term "baseline" refers to the last observation prior to randomisation of the patient. Means presented are the adjusted means. Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) model is used in the statistical analysis.
The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication.
Change from baseline in 24 hour urinary glucose excretion on Day 7 calculated as: UGE on Day 7 - UGE on baseline. Baseline is defined as the last observation prior to the first intake of any randomised trial medication.
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz).
Maximum measured concentration in plasma (Cmax).
Maximum measured concentration in plasma (tmax).
Terminal half-life in plasma (t1/2).
| Arm | Type | Description |
|---|---|---|
| Empagliflozin low dose | EXPERIMENTAL | - |
| Empagliflozin high dose | EXPERIMENTAL | - |
| Empagliflozin medium dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Empagliflozin | EXPERIMENTAL | starting dose 10mg; forced titration after 4 weeks 25mg dose |
| Name | Type | Description |
|---|---|---|
| Empagliflozin | DRUG | - |
| Placebo | DRUG | For blinding purposes |
| Empagliflozin low dose | DRUG | starting dose 10mg; forced titration after 4 weeks 25mg dose |
| Empagliflozin high dose | DRUG | starting dose 10mg; forced titration after 4 weeks 25mg dose |
| empagliflozin medium dose | DRUG | - |
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...
Empagliflozin is a small molecule being studied for chronic kidney disease, heart failure, myocardial infarction, type 2 diabetes, and type 1 diabetes. It is developed by Eli Lilly and Company (LLY) and is currently in Phase 3 clinical development for these indications.
Empagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, which works by blocking glucose reabsorption in the kidneys, leading to increased glucose excretion in urine. This mechanism helps lower blood sugar levels and may provide organ protection in conditions like chronic kidney disease and heart failure.
Empagliflozin is developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is currently in Phase 3 clinical trials for chronic kidney disease and other indications.
Empagliflozin is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The most advanced trial, EMPA-KIDNEY (NCT03594110), is a completed Phase 3 study in chronic kidney disease with 6,609 participants.
Empagliflozin has four completed clinical trials. Three are Phase 1 bioequivalence studies in healthy volunteers: NCT02266472, NCT02758171, and NCT03259490. The fourth is EMPA-KIDNEY (NCT03594110), a Phase 3 trial in chronic kidney disease with 6,609 participants across multiple countries.
Empagliflozin is the active ingredient in the brand-name drug Jardiance. While the data provided does not mention Jardiance, empagliflozin is widely known as the generic name for this medication, which is used to treat type 2 diabetes and other conditions.