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.
- 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.
- Data on file, MSD.