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Table A1: Study design and inclusion/exclusion criteria for studies used in pooled analysis of efficacy and safety of vildagliptin monotherapy
DurationTreatment armsAge (y)A1C (%)FPG (mmol/L)BMI
(kg/m2)ExclusionStudy 1 ADDIN REFMGR.CITE Dejager200775404Vildagliptin in drug-naive patients with type 2 diabetes: a 24-week, double-blind, randomized, placebo-controlled, multiple-dose study.Journal75404Vildagliptin in drug-naive patients with type 2 diabetes: a 24-week, double-blind, randomized, placebo-controlled, multiple-dose study.Dejager,S.Razac,S.Foley,J.E.Schweizer,A.2007patientspatienttype 2type 2 diabetesdiabetesArandomizedstudyIn File218223Horm Metab Res393K:\\II\75404.pdfHormone and Metabolic ResearchHorm Metab Res1(1)24 wkVilda 50 mg qd18-807.5-10.0<1522-45ALT, AST >3x ULNVilda 50 mg bidDirect bilirubin >1.3x ULNVilda 100 mg qd Serum creatinine >220 mol/LplaceboTSH outside normal rangeTG > 7.9 mmol/LStudy 2 ADDIN REFMGR.CITE Pi-Sunyer200775158Efficacy and tolerability of vildagliptin monotherapy in drug-naive patients with type 2 diabetesJournal75158Efficacy and tolerability of vildagliptin monotherapy in drug-naive patients with type 2 diabetesPi-Sunyer,F.X.Schweizer,A.Mills,D.Dejager,S.2007/1/11-adverse eventadverse eventsassessmentBIDbody weightclinicaldiabetesefficacyfrequencygroupgroupshemoglobinhospitalhypoglycemiamedicinemonotherapyNew YorkpatientpatientsplaceboQDrandomizedstudytolerabilitytype 2type 2 diabetesUSAWAweightIn File132138Diabetes Res Clin Pract761Department of Medicine, St. Luke's/Roosevelt Hospital Center, 1111 Amsterdam Avenue-Room 1020, New York, NY 10025, USAK:\\GG\75158.pdfDiabetes Research and Clinical PracticeDiabetes Res Clin Pract1(2)24 wkVilda 50 mg qd18-807.5-10.0<1522-45ALT, AST >3x ULNVilda 50 mg bidDirect bilirubin >1.3x ULNVilda 100 mg qdSerum creatinine >220 mol/LplaceboTSH outside normal rangeTG > 7.9 mmol/LStudy 3 ADDIN REFMGR.CITE Rosenstock200775403Efficacy and tolerability of initial combination therapy with vildagliptin and pioglitazone compared to component monotherapy in patients with type 2 diabetesJournal75403Efficacy and tolerability of initial combination therapy with vildagliptin and pioglitazone compared to component monotherapy in patients with type 2 diabetesRosenstock,J.Baron,M.A.Camisasca,R.P.Cressier,F.Couturier,A.Dejager,S.2007/3/1combinationcombination therapydiabetesefficacyMEDCONmonotherapypatientpatientspioglitazonetherapytolerabilitytype 2type 2 diabetesIn File175185Diabetes Obes Metab92K:\\II\75403.pdfDiabetes, Obesity and MetabolismDiabetes Obes MetabDiabetes, Obesity & Metabolism1(3)24 wkVilda 100 mg qd18-807.5-10.0<1522-45ALT, AST >2.5x ULNPio 30 mg qdDirect bilirubin >1.3x ULNVilda 50 mg + Pio 15 mg qdSerum creatinine >220 mol/LVilda 100 mg + Pio 30 mg qdClin. sign. TSH outside normal rangeTG > 7.9 mmol/LStudy 4 ADDIN REFMGR.CITE Rosenstock200775401Comparison of vildagliptin and rosiglitazone monotherapy in patients with type 2 diabetes: a 24-week, double-blind, randomized trialJournal75401Comparison of vildagliptin and rosiglitazone monotherapy in patients with type 2 diabetes: a 24-week, double-blind, randomized trialRosenstock,J.Baron,M.A.Dejager,S.Mills,D.Schweizer,A.2007comparisonrosiglitazonemonotherapypatientspatienttype 2type 2 diabetesdiabetesArandomizedrandomized trialtrialIn File217223Diabetes Care302Diabetes Care1(4)24 wkVilda 50 mg bid18-807.5-11.0<1522-45ALT, AST >2.5x ULNRosi 8 mg qdDirect bilirubin >1.3x ULNSerum creatinine >220 mol/LTSH outside normal rangeTG >7.9 mmol/LStudy 5 ADDIN REFMGR.CITE Schweizer200777608Comparison between vildagliptin and metformin to sustain reductions in HbA1c over one year in drug-naïve patients with type 2 diabetesJournal77608Comparison between vildagliptin and metformin to sustain reductions in HbA1c over one year in drug-naïve patients with type 2 diabetesSchweizer,A.Couturier,A.Foley,J.E.Dejager,S.2007/5/17comparisonmetforminHbA1conepatientspatienttype 2type 2 diabetesdiabetesIn FileDiabet MedK:\\JJ\77608.pdfDiabetic MedicineDiabet Med1(5)52 wkVilda 50 mg bid18-787.5-11.0<1522-45ALT, AST > 3 x U L N M e t u p t o 1 0 0 0 m g b i d D i r e c t b i l i r u b i n > 1 . 3 x U L N S e r u m c r e a t i n i n e > 1 3 2 m o l / L C l i n . s i g n . T S H o u t s i d e n o r m a l r a n g e T G > 7 . 9 m m o l / L S t u d y 6 1 2 w k V i l d a 5 0 m g q d e"1 8 9 . 0 - 1 1 . 0 2 2 - 4 5 A L T , A S T > 2 . 5 x U L N N C T V i l d a 5 0 mg bidDirect bilirubin >1.3x ULN00101673Pio 30 mg qdSerum creatinine >220 mol/LTSH outside normal rangeC-peptide <2.0 nmol/LTG > 7.9 mmol/LStudy 7 ADDIN REFMGR.CITE Ristic200564305Improved glycaemic control with dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes: vildagliptin (LAF237) dose responseJournal64305Improved glycaemic control with dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes: vildagliptin (LAF237) dose responseRistic,S.Byiers,S.Foley,J.Holmes,D.2005controldiabetesdose-responsedose responseglycaemic controlinhibitionpatientpatientsPDFtype 2type 2 diabetesIn File692698Diabetes Obes Metab7L:\\64305.pdfDiabetes, Obesity and MetabolismDiabetes Obes MetabDiabetes, Obesity & Metabolism1(6)12 wkVilda 100 mg qd30-756.8-10.0<1522-42ALT, AST, alk. phos. >2x ULNVilda 50 mg qdDirect bilirubin >1.3x ULNVilda 25 mg qdSerum creatinine >220 mol/LVilda 25 mg bidTSH outside normal rangePlaceboC-peptide <2.0 nmol/LTG >4.5 mmol/LStudy 8 ADDIN REFMGR.CITE Pratley200670421Twelve-week monotherapy with the DPP-4 inhibitor vildagliptin improves glycemic control in subjects with type 2 diabetesJournal70421Twelve-week monotherapy with the DPP-4 inhibitor vildagliptin improves glycemic control in subjects with type 2 diabetesPratley,R.E.Jauffret-Kamel,S.Galbreath,E.Holmes,D.2006controldiabetesglycemic controlinhibitormonotherapyPDFtype 2type 2 diabetesIn File423428Horm Metab Res38K:\\G\70421.pdfHormone and Metabolic ResearchHorm Metab Res1(7)12 wkVilda 25 mg bid e"3 0 6 . 8 - 1 1 . 0 <