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Late Breaking Data Released at ADA Showed that the Investigational,Use of Januvia and Metformin as Initial Combination Therapy,Provided Significant Glucose Lowering Efficacy over 54 Weeks in,Patients with Type 2 Diabetes

gle 600 mg oral dose of cyclosporine increased the AUC and Cmax of sitagliptin by approximately 29% and 68%, respectively. These modest changes in sitagliptin pharmacokinetics were not considered to be clinically meaningful. The renal clearance of sitagliptin was also not meaningfully altered. Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility A two-year carcinogenicity study was conducted in male and female rats given oral doses of sitagliptin of 50, 150, and 500 mg/kg/day. There was an increased incidence of combined liver adenoma/carcinoma in males and females and of liver carcinoma in females at 500 mg/kg. This dose results in exposures approximately 60 times the human exposure at the maximum recommended daily adult human dose (MRHD) of 100 mg/day based on AUC comparisons. Liver tumors were not observed at 150 mg/kg, approximately 20 times the human exposure at the MRHD. A two-year carcinogenicity study was conducted in male and female mice given oral doses of sitagliptin of 50, 125, 250, and 500 mg/kg/day. There was no increase in the incidence of tumors in any organ up to 500 mg/kg, approximately 70 times human exposure at the MRHD. Sitagliptin was not mutagenic or clastogenic with or without metabolic activation in the Ames bacterial mutagenicity assay, a Chinese hamster ovary (CHO) chromosome aberration assay, an in vitro cytogenetics assay in CHO, an in vitro rat hepatocyte DNA alkaline elution assay, and an in vivo micronucleus assay. In rat fertility studies with oral gavage doses of 125, 250, and 1000 mg/kg, males were treated for 4 weeks prior to mating, during mating, up to scheduled termination (approximately 8 weeks total) and females were treated 2 weeks prior to mating through gestation day 7. No adverse effect on fertility was observed at 125 mg/kg (approximately 12 times
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Breaking Medicine Technology:Unichem Pharmaceuticals (USA), Inc. Issues a Voluntary Nationwide Recall of Hydrochlorothiazide Tablets Due to the Potential Presence of Foreign Tablets 2Amgen Announces Appointment Of Fred Hassan To Board Of Directors 2Amgen Announces Appointment Of Fred Hassan To Board Of Directors 3Rx-to-OTC Switches -- Game Changers for the U.S. OTC Drugs Market through 2019, Sees Kline 2Rx-to-OTC Switches -- Game Changers for the U.S. OTC Drugs Market through 2019, Sees Kline 3
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Breaking Medicine News(10 mins):Health News:Nashville Otolaryngologist Dr. David Gilpin Launches Balloon Sinuplasty Website 2Health News:Nashville Otolaryngologist Dr. David Gilpin Launches Balloon Sinuplasty Website 3Health News:Finally…First Ever Professional Training Event for Doctors and Nurses Wanting to Offer Medical Marijuana Recommendations to Patients 2Health News:Finally…First Ever Professional Training Event for Doctors and Nurses Wanting to Offer Medical Marijuana Recommendations to Patients 3Health News:Finally…First Ever Professional Training Event for Doctors and Nurses Wanting to Offer Medical Marijuana Recommendations to Patients 4Health News:Finally…First Ever Professional Training Event for Doctors and Nurses Wanting to Offer Medical Marijuana Recommendations to Patients 5Health News:Manatee County’s Opioid Task Force Calls for More Funding and Face to Face Counseling After Overdose 2Health News:Manatee County’s Opioid Task Force Calls for More Funding and Face to Face Counseling After Overdose 3Health News:WCA Offers Shockwave; The Marketing Module for Hospital Wound Care Programs 2Health News:WCA Offers Shockwave; The Marketing Module for Hospital Wound Care Programs 3Health News:WCA Offers Shockwave; The Marketing Module for Hospital Wound Care Programs 4Health News:River Valley Physician Dr. Aggarwal is Making Changes to his Practice 2
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