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Positive Phase III Results for Empagliflozin in Diabetes
FDA filing expected this year (Jan. 7)
Preliminary results have been announced for four completed phase III trials of empagliflozin (Boehringer Ingelheim/Eli Lilly), an investigational sodium glucose co-transporter-2 (SGLT-2) inhibitor being studied for the treatment of patients with type 2 diabetes. In all four studies, the primary efficacy endpoint — defined as a significant change in hemoglobin A1c from baseline compared with placebo — was met with empagliflozin (10 mg and 25 mg) taken once daily.
The four pivotal studies are:
- Study 1245.20 (N = 986) evaluated empagliflozin monotherapy (10 mg and 25 mg) versus placebo for 24 weeks.
- Study 1245.23 (N = 1,504) compared empagliflozin (10 mg and 25 mg) as an add-on to metformin and metformin plus sulfonylurea versus placebo for 24 weeks.
- Study 1245.19 (N = 499) assessed empagliflozin (10 mg and 25 mg) as an add-on to pioglitazone and pioglitazone plus metformin versus placebo for 24 weeks.
- Study 1245.36 (N = 741) evaluated empagliflozin 25 mg in patients with type 2 diabetes with mild, moderate, or severe renal impairment, and empagliflozin 10 mg in patients with mild renal impairment versus placebo for 52 weeks.
The incidence of adverse events was similar for empagliflozin 10 mg, empagliflozin 25 mg, and placebo. Genital infections occurred more often with empagliflozin (both doses) compared with placebo.
Approximately 25.8 million Americans and an estimated 371 million people worldwide have diabetes. Type 2 diabetes is the most common form of the disease, accounting for an estimated 90% of all cases.
It is expected that a new drug application (NDA) for empagliflozin will be filed in 2013.
Source: Eli Lilly; January 7, 2013.