WHITEHOUSE STATION (dpa-AFX) - Merck & Co Inc (MRK) on Monday said a heart safety trial of its diabetes drug Januvia (sitagliptin) met its primary endpoint, sending its shares up about 4 percent in after-hours trade.
In the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), Januvia achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint, Merck said.
Among secondary endpoints, there was no increase in hospitalization for heart failure in the sitagliptin group versus placebo, Merck said.
The complete results of TECOS will be presented on June 8 at the 75th Scientific Sessions of the American Diabetes Association.
TECOS was an event-driven trial conducted in adults with type 2 diabetes and a history of cardiovascular disease. TECOS enrolled 14,724 participants from 38 countries between December 2008 and July 2012.
The study was designed to assess the CV safety of long-term treatment with Januvia as part of usual diabetes care compared with usual care without the drug.
The primary endpoint of the trial was the composite of time to the first of any of the following confirmed events: cardiovascular-related death, nonfatal myocardial infarction, nonfatal stroke, or unstable angina requiring hospitalization.
Januvia is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.
Merck shares were gaining $2.15 or 3.77% at $59.25 in after-hours trade on the NYSE.
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