5 new studies at major medical meeting further demonstrate clinical experience for JANUVIA
- 9 Sep 2008Five new studies at major medical meeting further demonstrate clinical experience for JANUVIA™ (sitagliptin)
Study data show longer term efficacy and safety and tolerability profile of JANUVIA up to two years
- JANUVIA and metformin as initial combination therapy demonstrated significant glucose-lowering efficacy over two years
- Pooled analysis of 6,139 patients showed JANUVIA was generally well tolerated in clinical trials, up to two years in duration
- Investigational study of the addition of JANUVIA to the combination of metformin and rosiglitazone significantly improved blood sugar control
- 52-week study of Japanese patients with an investigational dosing regimen demonstrated treatment with JANUVIA added to ongoing pioglitazone therapy also provided significant glucose lowering
- Additional analysis demonstrated that in patients with type 2 diabetes, JANUVIA provided glycemic control regardless of baseline characteristics of age, gender, BMI, HOMA-ß and P/I ratio
WHITEHOUSE STATION, N.J., Sept. 9, 2008 – New data analyses presented at the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD) showed initial combination therapy with the dipeptidyl peptidase-4 (DPP-4) inhibitor, JANUVIA™ (sitagliptin), and metformin provided improvements in blood sugar levels (as measured by A1Ci) over two years of treatment and was generally well tolerated. Also presented at the meeting was a separate, new pooled analysis of 6,139 patients that showed that JANUVIA was generally well tolerated in clinical trials up to two years in duration.
JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUVIA has not been studied in combination with insulin. JANUVIA is contraindicated for patients with history of a serious hypersensitivity reaction to sitagliptin, including anaphylaxis and angiedema.
More than six million total prescriptions for JANUVIA have been dispensed worldwide since launch. JANUVIA has received approval in 80 countries and is available in every region around the world. The U.S. Food and Drug Administration approved JANUVIA in October 2006 and the European Medicines Agency (EMEA) approved JANUVIA in Europe in April 2007.
Initial combination of JANUVIA and metformin provided glycemic improvements out to two years






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