Clinical Studies

Efficacy and Safety of the Dipeptidyl Peptidase-4 Inhibitor, Sitagliptin, Compared With the Sulfonylurea, Glipizide, in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone: A Randomized, Double-Blind, Non-Inferiority Trial

Nauck MA, Meininger G, Sheng D, et al; for Sitagliptin Study 024 Group. Diabetes Obes Metab. 2007;9:194–205.

Effect of Initial Combination Therapy With Sitagliptin, a Dipeptidyl Peptidase-4 Inhibitor, and Metformin on Glycemic Control in Patients With Type 2 Diabetes

Goldstein BJ, Feinglos MN, Lunceford JK, et al; for Sitagliptin 036 Study Group. Diabetes Care. 2007;30(8):1979–1987.

Efficacy and Safety of the Dipeptidyl Peptidase-4 Inhibitor, Sitagliptin, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Glimepiride Alone or on Glimepiride and Metformin

Hermansen K, Kipnes M, Luo E, et al; for Sitagliptin Study 035 Group. Diabetes Obes Metab. 2007;9(5):733–745.

Safety and Efficacy of Sitagliptin in Patients With Type 2 Diabetes and Chronic Renal Insufficiency

Chan JCN, Scott R, Arjona Ferreira JC, et al. Diabetes Obes Metab. 2008;10(7):545–555.

 

Selected Important Risk Information
When JANUVIA was used in combination with a sulfonylurea or insulin, medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo. Therefore, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.

The incidence (and rate) of hypoglycemia based on all reports of symptomatic hypoglycemia were: 12.2% (0.59 episodes/patient-year) for JANUVIA 100 mg in combination with glimepiride (with or without metformin), 1.8% (0.24 episodes/patient-year) for placebo in combination with glimepiride (with or without metformin), 15.5% (1.06 episodes/patient-year) for JANUVIA 100 mg in combination with insulin (with or without metformin), and 7.8% (0.51 episodes/patient-year) for placebo in combination with insulin (with or without metformin).

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