Comparison of vildagliptin and sitagliptin in patients with type 2 diabetes and severe renal impairment: a randomised clinical trial. Leading brands available in india for Sitagliptin is SITPIN and for Vildagliptin is VILDAZYME promoted by Edinburgh Pharmaceuticals

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Aims/Hypothesis - 

There are limited data comparing dipeptidyl peptidase-4 (DPP-4) inhibitors directly. We compared the safety and efficacy of vildagliptin and sitagliptin in patients with type 2 diabetes and severe renal impairment (RI).




Methods - 

This study was a parallel-arm, randomized, multicenter, double-blind, 24 week study conducted in 87 centers across Brazil and the USA. Patients with type 2 diabetes, either drug naïve or treated with any glucose-lowering agents, who had inadequate glycaemic control (HbA1c 6.5–10.0% [48–86 mmol/mol]) and an estimated GFR <30 ml min−1 [1.73 m]−2 were randomized (via interactive voice response technology) to vildagliptin 50 mg once daily or sitagliptin 25 mg once daily. These doses are recommended in this patient population and considered maximally effective. Participants, investigators and the sponsor were blinded to group assignment. Efficacy endpoints included change in HbA1c and fasting plasma glucose (FPG) at all visits and the primary safety endpoint was assessment of treatment-emergent adverse events.




Results - 

In total, 148 patients were randomized, 83 to vildagliptin and 65 to sitagliptin. All patients were analyses. After 24 weeks, the adjusted mean change in HbA1c was −0.54% (5.9 mmol/mol) from a baseline of 7.52% (59 mmol/mol) with vildagliptin and −0.56% (6.1 mmol/mol) from a baseline of 7.80% (62 mmol/mol) with sitagliptin (p = 0.874). FPG decreased by 0.47 ± 0.37 mmol/l with vildagliptin and increased by 0.16 ± 0.43 mmol/l with sitagliptin (p = 0.185). Both treatments were well tolerated with overall similar safety profiles.

Conclusions/Interpretation - 

At their recommended doses for severe RI, vildagliptin (50 mg once daily) compared with sitagliptin (25 mg once daily) demonstrated similar efficacy and both drugs were well tolerated. This study provides further support for the use of DPP-4 inhibitors in patients with severe RI.

Trial registration: ClinicalTrials.gov NCT00616811 (completed)

Funding: This study was planned and conducted by Novartis

Electronic Supplementary Material - 

The online version of this article (doi:10.1007/s00125-015-3655-z) contains peer-reviewed but unedited supplementary material, which is available to authorized users.

courtsey :Wolfgang Kothny,corresponding author Valentina Lukashevich, James E. Foley, Marc S. Rendell, and Anja Schweizer

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