Clinical Trials

Date: 2017-06-12

Type of information: Initiation of development program

phase:

Announcement: initiation of development program

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 kidney disease

Therapeutic area: Kidney diseases - Renal diseases

Country:

Trial details:

Latest news:

• On June 12, 2017, Boehringer Ingelheim and Eli Lilly announced plans to conduct a new, large clinical outcomes trial investigating Jardiance® (empagliflozin) tablets for the treatment of people with chronic kidney disease. The trial will enroll people with chronic kidney disease both with and without type 2 diabetes. The landmark EMPA-REG OUTCOME® trial also showed that Jardiance® reduced the risk for new-onset or worsening of kidney disease by 39 percent versus placebo when added to standard of care in adults with type 2 diabetes and established cardiovascular disease. Based on these results, BI and Lilly decided to formally investigate the potential of Jardiance® in people with chronic kidney disease. This and other ongoing mechanistic studies will allow the companies to further explore the potential mechanisms - including the reduction in glomerular pressure - by which empagliflozin may impact renal outcomes in those with chronic kidney disease.