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Comparison of vildagliptin and sitagliptin in patients with type 2 diabetes and severe renal impairment: a randomised clinical trial.

Kothny W, Lukashevich V, Foley JE, Rendell MS, Schweizer A - Diabetologia (2015)

Bottom Line: These doses are recommended in this patient population and considered maximally effective.Both treatments were well tolerated with overall similar safety profiles.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.

View Article: PubMed Central - PubMed

Affiliation: Novartis Pharma AG, Postfach, CH-4002, Basel, Switzerland, wolfgang.kothny@novartis.com.

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 <30 ml min(-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.

No MeSH data available.


Related in: MedlinePlus

Flow diagram of patient disposition. aMore than one reason for discontinuing
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Related In: Results  -  Collection


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Fig1: Flow diagram of patient disposition. aMore than one reason for discontinuing

Mentions: A total of 148 patients with type 2 diabetes and severe RI were randomised, 83 patients to vildagliptin (50 mg once daily) and 65 patients to sitagliptin (25 mg once daily), in addition to their stable background glucose-lowering medication. Of the 148 randomised patients, 117 patients completed the study, 64 (77.1%) in the vildagliptin group and 53 (81.5%) in the sitagliptin group, with the most common reasons for discontinuation being withdrawal of consent (vildagliptin 12.0%, sitagliptin 4.6%) and AEs (vildagliptin 4.8%, sitagliptin 6.2%) (Fig. 1). The recruited population with severe RI also included a limited number of patients with ESRD on haemodialysis (six patients in each treatment group).Fig. 1


Comparison of vildagliptin and sitagliptin in patients with type 2 diabetes and severe renal impairment: a randomised clinical trial.

Kothny W, Lukashevich V, Foley JE, Rendell MS, Schweizer A - Diabetologia (2015)

Flow diagram of patient disposition. aMore than one reason for discontinuing
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4526592&req=5

Fig1: Flow diagram of patient disposition. aMore than one reason for discontinuing
Mentions: A total of 148 patients with type 2 diabetes and severe RI were randomised, 83 patients to vildagliptin (50 mg once daily) and 65 patients to sitagliptin (25 mg once daily), in addition to their stable background glucose-lowering medication. Of the 148 randomised patients, 117 patients completed the study, 64 (77.1%) in the vildagliptin group and 53 (81.5%) in the sitagliptin group, with the most common reasons for discontinuation being withdrawal of consent (vildagliptin 12.0%, sitagliptin 4.6%) and AEs (vildagliptin 4.8%, sitagliptin 6.2%) (Fig. 1). The recruited population with severe RI also included a limited number of patients with ESRD on haemodialysis (six patients in each treatment group).Fig. 1

Bottom Line: These doses are recommended in this patient population and considered maximally effective.Both treatments were well tolerated with overall similar safety profiles.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.

View Article: PubMed Central - PubMed

Affiliation: Novartis Pharma AG, Postfach, CH-4002, Basel, Switzerland, wolfgang.kothny@novartis.com.

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 <30 ml min(-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.

No MeSH data available.


Related in: MedlinePlus