Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BI 10773 low dose · 2 trials · 1 indication
Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke. Percentage of patients with the event are presented.
Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment
| Arm | Type | Description |
|---|---|---|
| BI 10773 low dose | EXPERIMENTAL | BI 10773 tablets once daily |
| BI 10773 high dose | EXPERIMENTAL | BI 10773 tablets once daily |
| Placebo | PLACEBO_COMPARATOR | Placebo tablets matching BI 10773 |
| Name | Type | Description |
|---|---|---|
| BI 10773 low dose | DRUG | BI 10773 tablets once daily |
| Placebo BI 10773 high dose | DRUG | Placebo tablets identical to BI 10773 |
| BI 10773 high dose | DRUG | BI 10773 tablets once daily |
| Placebo BI 10773 low dose | DRUG | Placebo tablets identical to BI 10773 |
| BI 10773 placebo | DRUG | BI 10773 placebo |
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male or female patients on diet and exercise regimen who are drug naive or pre treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization. 3. Glycosylated...
BI 10773 low dose is used for the treatment of Type 2 Diabetes Mellitus. It is a small molecule being developed by Eli Lilly and Company for this metabolic condition. The drug has been studied in clinical trials involving patients with Type 2 diabetes.
BI 10773 low dose is a small molecule drug. The specific molecular target of BI 10773 low dose is not provided in the available information. It is being investigated for its efficacy and safety in patients with Type 2 Diabetes Mellitus.
BI 10773 low dose is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug for the treatment of Type 2 Diabetes Mellitus.
BI 10773 low dose is in Phase 3 clinical development. It has completed two clinical trials, including a Phase 3 cardiovascular outcome trial. The drug is investigational and has not been approved by regulatory authorities based on the available information.
BI 10773 low dose has been studied in two completed clinical trials. The first, NCT01011868, was a Phase 2 trial evaluating the drug in combination with insulin in patients with Type 2 diabetes. The second, NCT01131676, was the Phase 3 EMPA-REG OUTCOME trial, a cardiovascular outcome event study.
BI 10773 low dose is also known as empagliflozin. The Phase 3 trial NCT01131676 is titled 'BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME),' confirming that BI 10773 is the same compound as empagliflozin.