Date: 2013-01-07
Type of information:
phase: 3
Announcement: results
Company: Boehringer Ingelheim (Germany) - Eli Lilly (USA)
Product: empagliflozin (BI 10773)
Action mechanism: Empagliflozin inhibits SGLT-2 (sodium-dependent glucose co-transporter-2), which blocks glucose reuptake in the kidney, thereby removing excess glucose through the urine.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial
details: These four pivotal studies from the empagliflozin trial program are:
• Study 1245.20 (n=986) evaluated 10 mg and 25 mg doses of empagliflozin as monotherapy versus placebo for 24 weeks.
• Study 1245.23 (n=1,504) compared 10 mg and 25 mg doses of empagliflozin as an add-on to metformin and metformin plus sulfonylurea versus placebo for 24 weeks.
• Study 1245.19 (n=499) assessed 10 mg and 25 mg doses of empagliflozin as an add-on to pioglitazone and pioglitazone plus metformin versus placebo for 24 weeks.
• Study 1245.36 (n=741) evaluated 25 mg dose of empagliflozin in patients with type 2 diabetes with mild, moderate or severe renal impairment, and 10 mg dose in those with mild renal impairment versus placebo for 52 weeks.
Empagliflozin is being investigated in adults with type 2 diabetes in a Phase III clinical trial program that will enroll over 14,500 patients. In total, this program comprises eight multinational clinical trials, including a large cardiovascular outcome trial.
Latest
news: Boehringer Ingelheim and Eli Lilly have top-line results for four completed Phase III clinical trials for empagliflozin. In all four studies, the primary efficacy endpoint, defined as significant change in HbA1c from baseline compared to placebo, was met with empagliflozin (10 and 25 mg) taken once daily.
Incidence of adverse events was similar for placebo, empagliflozin 10mg and 25mg. Genital infections occurred more often with empagliflozin (both dosages) compared with placebo. This safety information is consistent with findings reported in the Phase II study results for empagliflozin.
The pivotal studies for empagliflozin completed in 2012, and Boehringer Ingelheim and Lilly anticipate filing for regulatory review in the U.S., Europe and Japan in 2013. Boehringer Ingelheim and Lilly plan to present detailed data disclosures for many of these studies at scientific medical meetings and publications in 2013 and 2014.
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on four pipeline compounds including empaglifozin.
