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As an adjunct to diet and exercise for appropriate patients with type 2 diabetes

Significant HbA1c Reductions

Study Design: A multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety of adding sitagliptin 100 mg once daily to metformin ≥1500 mg/day in 190 patients with type 2 diabetes inadequately controlled on metformin (HbA1c ≥8%–≤11%). The primary end point was HbA1c change from baseline at 18 weeks.1

CI=confidence interval; FAS=full-analysis-set; LS=least squares.


  • Januvia and Janumet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
  • Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis. If pancreatitis is suspected, Januvia or Janumet should be discontinued; if confirmed, Januvia or Janumet should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Resolution of pancreatitis has been observed after discontinuation of sitagliptin, but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported.
  • Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea. Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea or insulin may be considered.
  • For Januvia only – Renal Impairment: Lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis.
  • Janumet is contraindicated in patients with GFR < 30mL/min and should be temporarily discontinued during conditions with the potential to alter renal function.

  1. Raz I, Chen Y, Wu M, et al. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008;24(2):537–550.
  2. Data on file, MSD.