Januvia(sitagliptin)

Januvia (sitagliptin) is a medication approved in the U.S. on October 16th, 2006, for the treatment of type 2 diabetes. Clinical studies included 5200 patients with type 2 diabetes, with a mean age of 55 years. Pre-approval clinical safety and efficacy studies involved 3884 patients, including 725 patients aged 65 years and over, and 61 patients aged 75 years and over.

Efficacy findings from regulatory reviews indicate that sitagliptin resulted in an HbA1c change from baseline of -0.5% and a difference from placebo of -0.6%. Another study showed an HbA1c change from baseline of -0.6% and a difference from placebo of -0.8%. Patients achieving A1C <7% was 36% in one study, compared to 16% in another. Fasting Plasma Glucose (FPG) change from baseline was -13 mg/dL, with a difference from placebo of -20 mg/dL. The 2-hour Postprandial Glucose (PPG) change from baseline was -49 mg/dL, with a difference from placebo of -47 mg/dL.

Safety concerns noted in the reviews include acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis. The pancreatitis reporting rate for sitagliptin was 70 cases per million-person years based on OSE data. The incidence of hypoglycemia ranged from 4.9% to 32.0%. There were 15 postmarketing reports of cutaneous vasculitis for sitagliptin or sitagliptin/metformin FDC, with 8 serious reports and 7 non-serious reports. The FDA AERS database reported 88 cases of pancreatitis and 2 cases of necrotizing pancreatitis associated with sitagliptin.