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New Study Data: JANUVIA™ (sitagliptin) Significantly Reduced Blood Sugar Levels and Was Not Associated with Hypoglycemia in Elderly Patients with Type 2 Diabetes
Date:11/21/2008

glucose load or a meal.
  • a two-day study in healthy subjects, sitagliptin alone increased active GLP-1 concentrations, whereas metformin alone increased active and total GLP-1 concentrations to similar extents. Co-administration of sitagliptin and metformin had an additive effect on active GLP-1 concentrations. Sitagliptin, but not metformin, increased active GIP concentrations. It is unclear how these findings relate to changes in glycemic control in patients with type 2 diabetes.

  • studies with healthy subjects, JANUVIA did not lower blood glucose or cause hypoglycemia.

Cardiac Electrophysiology

  • a randomized, placebo-controlled crossover study, 79 healthy subjects were administered a single oral dose of JANUVIA 100mg, JANUVIA 800mg (8 times the recommended dose), and placebo. At the recommended dose of 100mg, there was no effect on the QTc interval obtained at the peak plasma concentration, or at any other time during the study. Following the 800mg dose, the maximum increase in the placebo-corrected mean change in QTc from baseline was observed at 3 hours postdose and was 8.0msec. This increase is not considered to be clinically significant. At the 800mg dose, peak sitagliptin plasma concentrations were approximately 11 times higher than the peak concentrations following a 100mg dose.

  • patients with type 2 diabetes administered JANUVIA 100mg (N=81) or JANUVIA 200mg (N=63) daily, there were no meaningful changes in QTc interval based on ECG data obtained
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 New Study Data: JANUVIA™ (sitagliptin) Significantly Reduced Blood Sugar Levels and Was Not Associated with Hypoglycemia in Elderly Patients with Type 2 Diabetes 
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