Clinical Trials

Date: 2017-03-17

Type of information: Initiation of the trial

phase: 3

Announcement: initiation of the trial

Company: Boehringer Ingelheim (Germany) Eli Lilly (USA - IN)

Product: Jardiance® (empagliflozin)

Action mechanism:

SGLT2 inhibitor. Empagliflozin inhibits SGLT-2 (sodium-dependent glucose co-transporter-2), which blocks glucose reuptake in the kidney, thereby removing excess glucose through the urine.
Empagliflozin is the first type 2 diabetes medicine to have data on the reduction of the risk of cardiovascular death included in the label in several countries. The EMPA-REG OUTCOME® trial demonstrated that empaglifozin reduced the risk of cardiovascular death by 38 percent versus placebo in patients with type 2 diabetes and established cardiovascular disease when added to standard of care (including glucose-lowering agents and cardiovascular drugs).
The product has been developed by Boehringer Ingelheim and Eli Lilly. In January 2011, the two companies have announced an alliance in the field of diabetes that centers on four pipeline compounds including empaglifozin.

Disease: chronic heart failure

Therapeutic area: Cardiovascular diseases

Country: Germany, Italy, Poland, Romania, UK (NCT03057951) France ,Germany, Italy, Netherlands, Poland, UK (NCT03057977

Trial details:

The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) HF clinical trial programme will investigate once daily empagliflozin, compared to placebo, in heart failure patients, both with and without type 2 diabetes receiving current standard of care. The programme comprises two Phase III, randomised, double-blind trials which assess heart failure in patients with preserved ejection fraction or patients with reduced ejection fraction:
EMPEROR HF-Preserved (NCT03057951) will investigate the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction.
- Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalisation for heart failure) [Time Frame: up to 38 months]
- Anticipated number of patients: 4,100
- Estimated completion: 2020
EMPEROR HF-Reduced (NCT03057977) will investigate the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction.
- Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalisation for heart failure) [Time Frame: up to 38 months]
- Anticipated number of patients: 2,800
- Estimated completion: 2020.

Latest news:

• On March 17, 2017, Boehringer Ingelheim and Eli Lilly announced that the EMPEROR HF clinical trial programme was initiated. EMPEROR HF comprises two Phase III outcome studies that will investigate empagliflozin for the treatment of people with chronic heart failure. The trials will involve not only people with type 2 diabetes, who have heart failure, but also heart failure patients who do not have diabetes. Both trials will assess the impact of treatment with empagliflozin on cardiovascular death and hospitalisation for heart failure as primary endpoints. The two trials will involve approximately 7,000 patients in total and are anticipated to complete in 2020.