Pivotal Trial Results Announced for Empagliflozin in Diabetes
Boehringer Ingelheim and Lilly announced top-line results for four completed Phase 3 clinical trials for empagliflozin, being studied for treatment of patients with type 2 diabetes (T2D). Empagliflozin is an investigational sodium glucose co-transporter-2 (SGLT-2) inhibitor.
These four pivotal studies from the empagliflozin trial program were:
- Study 1245.20 (n=986) evaluated 10mg and 25mg doses of empagliflozin as monotherapy vs. placebo for 24 weeks.
- Study 1245.23 (n=1,504) compared 10mg and 25mg doses of empagliflozin as an add-on to metformin and metformin plus sulfonylurea vs. placebo for 24 weeks.
- Study 1245.19 (n=499) assessed 10mg and 25mg doses of empagliflozin as an add-on to pioglitazone (Actos; Takeda) and pioglitazone plus metformin (Actoplus Met; Takeda) vs. placebo for 24 weeks.
- Study 1245.36 (n=741) evaluated 25mg dose of empagliflozin in patients with type 2 diabetes with mild, moderate or severe renal impairment, and 10mg dose in those with mild renal impairment vs. placebo for 52 weeks.
In all four studies, the primary efficacy endpoint, defined as significant change in HbA1c from baseline compared to placebo, was met with empagliflozin (10mg and 25mg) taken once daily.