Comparison of vildagliptin and sitagliptin in patients with type 2 diabetes and severe renal impairment

a randomised clinical trial

Wolfgang Kothny, Valentina Lukashevich, James E. Foley, Marc S. Rendell, Anja Schweizer

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

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, randomised, multicentre, double-blind, 24 week study conducted in 87 centres across Brazil and the USA. Patients with type 2 diabetes, either drug naive 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 −1 [1.73 m]−2 were randomised (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 randomised, 83 to vildagliptin and 65 to sitagliptin. All patients were analysed. 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

Original languageEnglish
Pages (from-to)2020-2026
Number of pages7
JournalDiabetologia
Volume58
Issue number9
DOIs
StatePublished - Sep 7 2015

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Type 2 Diabetes Mellitus
Randomized Controlled Trials
Kidney
Dipeptidyl-Peptidase IV Inhibitors
Safety
Glucose
Fasting
Double-Blind Method
Pharmaceutical Preparations
Brazil
vildagliptin
Sitagliptin Phosphate
Research Personnel
Technology
Therapeutics
Population

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Comparison of vildagliptin and sitagliptin in patients with type 2 diabetes and severe renal impairment : a randomised clinical trial. / Kothny, Wolfgang; Lukashevich, Valentina; Foley, James E.; Rendell, Marc S.; Schweizer, Anja.

In: Diabetologia, Vol. 58, No. 9, 07.09.2015, p. 2020-2026.

Research output: Contribution to journalArticle

Kothny, Wolfgang ; Lukashevich, Valentina ; Foley, James E. ; Rendell, Marc S. ; Schweizer, Anja. / Comparison of vildagliptin and sitagliptin in patients with type 2 diabetes and severe renal impairment : a randomised clinical trial. In: Diabetologia. 2015 ; Vol. 58, No. 9. pp. 2020-2026.
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AU - Rendell, Marc S.

AU - Schweizer, Anja

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N2 - 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, randomised, multicentre, double-blind, 24 week study conducted in 87 centres across Brazil and the USA. Patients with type 2 diabetes, either drug naive 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 −1 [1.73 m]−2 were randomised (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 randomised, 83 to vildagliptin and 65 to sitagliptin. All patients were analysed. 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

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