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New analysis shows that patients with Type 2 diabetes and mild renal impairment had similar improvement in blood sugar control and experienced less hypoglycemia with JANUVIA (sitagliptin) compared to sulfonylurea
Date:6/22/2013

h a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUVIA or with any other antidiabetic drug.

Design of Post-hoc Analysis

This post-hoc analysis pooled data from three randomized, double-blind studies conducted over 25-30 weeks that included 1,180 patients with type 2 diabetes and mild renal insufficiencyii. The analysis compared the effects of JANUVIA 100 mg (n=584) once daily to a sulfonylurea, either glipizide or glimepiride (n=596) in titrated doses, on change from baseline in A1C, fasting plasma glucose, body weight, and the incidence of symptomatic hypoglycemia.

Selected Important Risk Information About JANUVIA (sitagliptin) 50 mg, 100 mg tablets

JANUVIA is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.

There have been postmarketing reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUVIA. After initiating JANUVIA (sitagliptin), observe patients carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue JANUVIA and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA.

Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter. A dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with end-stage renal disease requiring hemodialysis or peritoneal dialysis. Caution should be used to ensure that the correct dose of JANUVIA is prescribed.

There have been postmarketing repor
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Contact: Pam Eisele
908-423-5042

Kim Hamilton
908-423-6831
908-391-0131

Carol Ferguson
908-423-4465

Merck


Source:Eurekalert

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