Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Linagliptin/Metformin · 3 trials · 1 indication
AUC0-tz, Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 to the last quantifiable data point is presented. Standard error (SE) is a geometric SE.
AUC0-tz, Area under the concentration-time curve of the metformin in plasma over the time interval from 0 to the last quantifiable data point is presented. Standard error (SE) is a geometric SE.
AUC0-72, area under the concentration-time curve of the linagliptin in plasma over the time interval from 0 to 72 h is presented. SE is a geometric SE.
Cmax, maximum measured concentration of the empagliflozin in plasma is presented. SE is a geometric SE.
Cmax, maximum measured concentration of the linagliptin in plasma is presented. SE is a geometric SE.
Cmax, maximum measured concentration of the metformin in plasma is presented. SE is a geometric SE.
AUC 0-72 (area under concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
AUC 0-t (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
| Arm | Type | Description |
|---|---|---|
| Test treatment (T) | EXPERIMENTAL | Low strength empagliflozin/linagliptin/metformin XR fixed dose combination tablet |
| Reference treatment (R) | EXPERIMENTAL | Single tablets of empagliflozin + linagliptin + metformin XR |
| FDC first, fasted | EXPERIMENTAL | Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fasted condition |
| Single tablets first, fasted | EXPERIMENTAL | single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fasted condition |
| FDC first, fed | EXPERIMENTAL | Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fed condition |
| Single tablets first, fed | EXPERIMENTAL | single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fed condition |
| Name | Type | Description |
|---|---|---|
| Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination) | DRUG | single dose |
| Empagliflozin | DRUG | single dose |
| Linagliptin | DRUG | single dose |
| Metformin HCl | DRUG | single dose |
| Linagliptin/Metformin ER FDC | DRUG | 1x Linagliptin/Metformin FDC tablet |
| Metformin ER | DRUG | 2x Metformin ER tablets |
Inclusion Criteria: * Healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests * Age of 18...
Linagliptin is a small molecule drug being developed for Type 2 Diabetes Mellitus and has been studied in healthy subjects. It is in Phase 3 clinical development by Eli Lilly and Company. The drug has been evaluated in 11 completed trials with a total enrollment of 11,124 participants.
Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by blocking the enzyme DPP-4, which degrades incretin hormones. This increases active incretin levels, helping to regulate blood glucose by enhancing insulin secretion and reducing glucagon release in a glucose-dependent manner.
Linagliptin is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is in Phase 3 clinical development for Type 2 Diabetes Mellitus.
Linagliptin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has completed 11 clinical trials, with no active trials currently ongoing.
Linagliptin has been studied in 11 completed clinical trials. Notable trials include NCT01204294, a Phase 3 study in Japan for Type 2 Diabetes Mellitus, and several Phase 1 bioequivalence studies in healthy subjects, such as NCT02084082 and NCT02121509, which tested fixed-dose combination tablets with metformin.
Linagliptin is the generic name for the drug marketed as Tradjenta. It is a DPP-4 inhibitor used for the treatment of Type 2 Diabetes Mellitus. The drug is being developed by Eli Lilly and Company and is currently in Phase 3 clinical trials.