Mon Jan 7, 2013 11:54am EST
(Reuters) – Eli Lilly and Co and Boehringer Ingelheim pronounced on Monday that an initial diagnosis for form 2 diabetes, empagliflozin, met a primary idea of significantly obscure blood sugarine levels in 4 late-stage trials.
The companies pronounced they design to record for regulatory examination of a drug in a United States, Europe and Japan in 2013 and will benefaction minute information from a trials this year and next.
The trials complicated empagliflozin during 10 milligrams and 25 mg alone and in multiple with other common diabetes treatments, such as metformin and Takeda Pharmaceutical Co’s Actos, opposite a placebo. One of a trials tested a Lilly drug in patients with marred kidney function.
Empagliflozin belongs to a new category of diabetes treatments called SGLT2 inhibitors that work by restraint reabsorption of glucose by a kidney and increases glucose excretion in a urine to reduce blood sugar.
An advisory row to a U.S. Food and Drug Administration this week is scheduled to plead a Johnson Johnson drug from a same category called canagliflozin, that is available an capitulation decision.
Dapagliflozin, a drug from AstraZeneca Plc and Bristol-Myers Squibb Co that belongs to a same SGLT2 class, had progressing been deserted by a FDA over reserve concerns, such as liver problems.
Lilly and Boehringer pronounced occurrence of inauspicious side effects was identical for remedy and both doses of empagliflozin. However, genital infections occurred some-more mostly with a diagnosis than with placebo, as had been seen in progressing studies with a category of drugs.
The empagliflozin Phase III program, including a vast heart reserve study, involves some-more that 14,500 patients, a companies said.
Boehringer and Lilly are collaborating on several diabetes drugs. On Monday, they pronounced usually Lilly would continue with growth of one of a treatments, famous as LY2605541.
About 371 million people worldwide are estimated to have diabetes. Type 2 is a many common form of a quick flourishing disease, accounting for about 90 percent of all cases.
Lilly shares were down about 0.4 percent during $51.34 in late morning trade on a New York Stock Exchange
(Reporting By Bill Berkrot and Caroline Humer; Editing by Maureen Bavdek and Sofina Mirza-Reid)