Reason for request

Renewal of inclusion

In type 2 diabetics with renal impairment, low actual benefit in monotherapy and in combination with a sulfonylurea

Insufficient actual benefit in combination with insulin

 

»  In type 2 diabetics with moderate renal impairment for whom metformin is contraindicated, JANUVIA 50 mg and XELEVIA 50 mg have Marketing Authorisation to improve glycaemic control in monotherapy, in dual therapy in combination with a sulfonylurea or with insulin.

»  For patients with moderate renal impairment (CrCl ≥ 30 to < 50 ml/min), the dosage is 50 mg sitagliptin once daily.

»  In dual therapy with insulin or a sulfonylurea, in the absence of any clinical data, the efficacy/adverse effect ratio of JANUVIA 50 mg and XELEVIA 50 mg is poorly established in type 2 diabetics with moderate renal impairment. Sitagliptin 50 mg can possibly be combined with a sulfonylurea, but is not recommended with insulin.

 


Clinical Benefit

Substantial

-

Low
Insufficient
Comments

Therapeutic use

-

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