Sustained A1C Reductions Over 2 Years
For appropriate patients with type 2 diabetes...
Start and stay with the power of JANUMET
In extension-study participants on 104 weeks of initial therapy, JANUMET delivered sustained A1C reductions over 2 years1
Selected Important Risk Information
JANUMET is contraindicated in patients with renal disease or renal dysfunction (serum creatinine levels ≥1.5 mg/dL in males and ≥1.4 mg/dL in females) or abnormal creatinine clearance; acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma; or history of a serious hypersensitivity reaction to JANUMET or sitagliptin (one of the components of JANUMET), such as anaphylaxis or angioedema.
Temporarily discontinue JANUMET in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. Avoid use in patients with hepatic disease. Temporarily discontinue for intercurrent serious conditions, infection, or surgery.Please read the Boxed Warning about lactic acidosis.
JANUMET: Effects of 104 weeks of initial combination therapy1,2
To assess the 104-week efficacy and safety of JANUMET in patients with type 2 diabetes who had inadequate glycemic control (A1C 7.5%–11%) on diet and exercise.
A 50-week extension study (after 24-week phase A period and 30-week phase B period of initial combination therapy with JANUMET, for a total of 104 weeks): Following completion of phases A and B, patients were asked to enroll in a 50-week extension study. Patients were eligible if they completed the initial 54-week study and took study medication with ≥75% compliance.
Enrolled patient population
Patients aged 18 to 78 years who were either on or not on an oral antihyperglycemic agent at screening, with an A1C of 7.5%–11% after wash off.
Primary: A1C change at week 104.
Select secondary: Change in FPG and PPG.
Patients who demonstrated poor glycemic control, defined as A1C >7.5% after week 54, initiated rescue therapy with open-label glyburide/glibenclamide.
References 1. Goldstein BJ, Feinglos MN, Lunceford JK, et al; for Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007;30(8):1979–1987. Dr. Goldstein is currently an employee at Merck, but was in academia at the time of publication. 2. Williams-Herman D, Johnson J, Teng R, et al. Efficacy and safety of sitagliptin and metformin as initial combination therapy and as monotherapy over 2 years in patients with type 2 diabetes. Diabetes Obes Metab. 2010;12(5):442–451.