Evidence to support the use of vildagliptin monotherapy in the treatment of type 2 diabetes mellitus

Figures & data

Table 1 Vildagliptin monotherapy studies

Study	Study description	Randomized patients*	Treatment duration**	Reference
1	Placebo-controlled dose-ranging study (efficacy/safety) in drug-naïve T2DM patients (HbA1c 7.5%–10.0%)	354	24 weeks	^Citation34
2	Placebo-controlled dose-ranging study (efficacy/safety) in drug-naïve T2DM patients (HbA1c 7.5%–10.0%)	632	24 weeks	^Citation25
3	Placebo-controlled long-term efficacy/safety study in drug-naïve T2DM patients with mild hyperglycemia (HbA1c 6.2%–7.5%)	306	52 weeks	^Citation31
4	Placebo-controlled 52-week extension to study 3	131	104 weeks	^Citation30
5	Placebo-controlled mechanistic study in drug-naïve T2DM patients with mild hyperglycemia (HbA1c ≤ 7.5%)	89	52 weeks	^Citation36
6	Placebo-controlled efficacy/mechanistic study in diet-controlled T2DM patients (HbA1c 6.3%–10.0%)	40	4 weeks	^Citation38
7	Placebo-controlled mechanistic study in drug-naïve T2DM patients (HbA1c 6.5%–10.0%)	31	4 weeks	^Citation39
8	Placebo-controlled mechanistic study in drug-naïve T2DM patients (HbA1c ≤ 7.5%)	30	4 weeks	^Citation40
9	Active-controlled (metformin) long-term efficacy/safety study in drug-naïve T2DM patients (HbA1c 7.5%–11.0%)	780	52 weeks	^Citation32
10	Active-controlled (metformin) 52-week extension to study 9	463	104 weeks	^Citation27
11	Active-controlled (metformin) efficacy/safety study in drug-naïve elderly (≥65 years) T2DM patients (HbA1c 7.0%–9.0%)	335	24 weeks	^Citation33
12	Active-controlled (gliclazide) long-term efficacy/safety study in drug-naïve T2DM patients (HbA1c 7.5%–11%)	1092	104 weeks	^Citation26
13	Active-controlled (acarbose) efficacy/safety study in drug-naïve T2DM patients (HbA1c 7.5%–11%)	661	24 weeks	^Citation28
14	Active-controlled (rosiglitazone) efficacy/safety study in drug-naïve T2DM patients (HbA1c 7.5%–11%)	786	24 weeks	^Citation29
15	Active-controlled (voglibose) efficacy/safety study in Japanese T2DM patients (HbA1c 6.5%–10%)	380	12 weeks	^Citation37
16	Placebo-controlled study in subjects with IGT	179	12 weeks	^Citation49
17	Uncontrolled study in subjects with IFG	22	6 weeks	^Citation50
18	Pooled monotherapy analysis in patients < and ≥65 years	NA	≥24 weeks	^Citation10
19	Pooled monotherapy analysis in patients < and ≥75 years	NA	≥24 weeks	^Citation45

Notes:

* For extension studies, patients who entered extension;

** For extension studies, duration of core + extension study.

Abbreviations: HbA_1c, glycosylated hemoglobin; IGT, impaired glucose tolerance; IFG, impaired fasting glucose; NA, not applicable; T2DM, type 2 diabetes.

Figure 1 Time course of mean HbA_1c during one year of treatment with vildagliptin 50 mg once daily (closed triangles) or placebo (open circles).

Notes: Vildagliptin: n = 153 at baseline and 138 at week 52; placebo: n = 149 at baseline and 131 at week 52. Mean ± standard error. ***P < 0.0001 versus placebo. Adapted with permission from Scherbaum et al.³¹

Figure 2 Change from baseline in HbA_1c (A), fasting plasma glucose (B), and weight (C) with vildagliptin 50 mg twice daily in a pooled monotherapy population in patients stratified by age.⁴⁵ *P < 0.05 versus baseline; baseline values for patients <75 years and ≥75 years were 8.7% and 8.3%, respectively (A); 10.5 mmol/L and 9.7 mmol/L (B); and 86.1 kg and 74.9 kg (C).

Pi-SunyerFXSchweizerAMillsDDejagerSEfficacy and tolerability of vildagliptin monotherapy in drug-naive patients with type 2 diabetesDiabetes Res Clin Pract20077613213817223217

 PubMed Web of Science ®Google Scholar

DejagerSRazacSFoleyJESchweizerAVildagliptin in drug-naive patients with type 2 diabetes: a 24-week, double-blind, randomized, placebo-controlled, multiple-dose studyHorm Metab Res20073921822317373638

 PubMed Web of Science ®Google Scholar

ScherbaumWASchweizerAMariAEfficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemiaDiabetes Obes Metab20081067568218248490

 PubMed Web of Science ®Google Scholar

ScherbaumWASchweizerAMariAEvidence that vildagliptin attenuates deterioration of glycaemic control during 2-year treatment of patients with type 2 diabetes and mild hyperglycaemiaDiabetes Obes Metab2008101114112418355325

 PubMed Web of Science ®Google Scholar

FoleyJEBunckMCMoller-GoedeDLBeta cell function following 1 year vildagliptin or placebo treatment and after 12 week washout in drug-naive patients with type 2 diabetes and mild hyperglycaemia: a randomised controlled trialDiabetologia2011541985199121547496

 PubMed Web of Science ®Google Scholar

AhrenBLandin-OlssonMJanssonPASvenssonMHolmesDSchweizerAInhibition of dipeptidyl peptidase-4 reduces glycemia, sustains insulin levels, and reduces glucagon levels in type 2 diabetesJ Clin Endocrinol Metab2004892078208415126524

 PubMed Web of Science ®Google Scholar

MatikainenNManttariSSchweizerAVildagliptin therapy reduces postprandial intestinal triglyceride-rich lipoprotein particles in patients with type 2 diabetesDiabetologia2006492049205716816950

 PubMed Web of Science ®Google Scholar

AhrenBSchweizerADejagerSVildagliptin enhances islet responsiveness to both hyper- and hypoglycemia in patients with type 2 diabetesJ Clin Endocrinol Metab2009941236124319174497

 PubMed Web of Science ®Google Scholar

SchweizerACouturierAFoleyJEDejagerSComparison between vildagliptin and metformin to sustain reductions in HbA(1c) over 1 year in drug-naive patients with Type 2 diabetesDiabet Med20072495596117509069

 PubMed Web of Science ®Google Scholar

GokeBHershonKKerrDEfficacy and safety of vildagliptin monotherapy during 2-year treatment of drug-naive patients with type 2 diabetes: comparison with metforminHorm Metab Res20084089289518726829

 PubMed Web of Science ®Google Scholar

SchweizerADejagerSBosiEComparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes: a 24-week, double-blind, randomized trialDiabetes Obes Metab20091180481219476473

 PubMed Web of Science ®Google Scholar

FoleyJESreenanSEfficacy and safety comparison between the DPP-4 inhibitor vildagliptin and the sulfonylurea gliclazide after two years of monotherapy in drug-naive patients with type 2 diabetesHorm Metab Res20094190590919705345

 PubMed Web of Science ®Google Scholar

PanCYangWBaronaJPComparison of vildagliptin and acarbose monotherapy in patients with type 2 diabetes: a 24-week, double-blind, randomized trialDiabet Med20082543544118341596

 PubMed Web of Science ®Google Scholar

RosenstockJBaronMADejagerSMillsDSchweizerAComparison of vildagliptin and rosiglitazone monotherapy in patients with type 2 diabetes: a 24-week, double-blind, randomized trialDiabetes Care20073021722317259484

 PubMed Web of Science ®Google Scholar

IwamotoYKashiwagiAYamadaNEfficacy and safety of vildagliptin and voglibose in Japanese patients with type 2 diabetes: a 12-week, randomized, double-blind, active-controlled studyDiabetes Obes Metab20101270070820590747

 PubMed Web of Science ®Google Scholar

RosenstockJFoleyJERendellMEffects of the dipeptidyl peptidase-IV inhibitor vildagliptin on incretin hormones, islet function, and postprandial glycemia in subjects with impaired glucose toleranceDiabetes Care200831303517947341

 PubMed Web of Science ®Google Scholar

UtzschneiderKMTongJMontgomeryBThe dipeptidyl peptidase- 4 inhibitor vildagliptin improves beta-cell function and insulin sensitivity in subjects with impaired fasting glucoseDiabetes Care20083110811317909087

 PubMed Web of Science ®Google Scholar

PratleyRERosenstockJPi-SunyerFXManagement of type 2 diabetes in treatment-naive elderly patients: benefits and risks of vildagliptin monotherapyDiabetes Care2007303017302217878242

 PubMed Web of Science ®Google Scholar

SchweizerADejagerSFoleyJEShaoQKothnyWClinical experience with vildagliptin in the management of type 2 diabetes in a patient population ≥75 years: a pooled analysis from a database of clinical trialsDiabetes Obes Metab201113556421114604

 PubMed Web of Science ®Google Scholar