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An Investigational Study Released at ADA Showed that Initial,Combination Therapy with Januvia (sitagliptin) and Metformin Led to,Improvement in Markers of Beta Cell Function in Patients with Type,2 Diabetes

ttings. There are no contraindications for JANUVIA.

Sitagliptin is also a component of JANUMET(TM) (sitagliptin/metformin HCl), the first and only tablet combining a DPP-4 inhibitor and metformin for the treatment of type 2 diabetes. JANUMET is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with the combination of sitagliptin and metformin. Consistent with the labeling for metformin alone, JANUMET is contraindicated in patients with renal disease, renal dysfunction, or abnormal creatinine clearance; and acute or chronic metabolic acidosis, including diabetic ketoacidosis. JANUMET should not be used in patients with type 1 diabetes. Consistent with the labeling for metformin alone, the labeling for JANUMET contains a boxed warning for lactic acidosis, a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment.

Investigational use of JANUVIA and metformin as initial combination therapy led to improvement in markers of beta cell function in patients with type 2 diabetes (0533-P; Study #036)

In this investigational study, the effects of JANUVIA and metformin on beta cell function were examined in patients with type 2 diabetes who participated in a 24-week, placebo-controlled study in which 1,091 patients were randomized to one of six treatments: JANUVIA 50 mg/metformin 1000 mg twice daily (n=182); JANUVIA 50 mg/metformin 500 mg twice daily (n=190); metformin 1000 mg twice daily (n=182); metformin 500 mg twice daily (n=182); JANUVIA 100 mg once-daily (n=179); or placebo (n=176). Of these, a subset of 500 patients underwent frequently sampled meal tolerance tests. Beta cell function was measured using a computer model based evaluation. Parameters of beta cell function from this model allowed for the estimation of the insulin secretion r
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