Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00860288

Collaborator

(none)

1,988

Enrollment

187

Locations

Arms

24.9

Duration (Months)

10.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as add-on therapy to metformin

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin Drug: Metformin Drug: Placebo Drug: Sitagliptin	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1988 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vildagliptin Dose 1	Drug: Vildagliptin Drug: Metformin
Experimental: Vildagliptin Dose 2	Drug: Vildagliptin Drug: Metformin
Placebo Comparator: Placebo	Drug: Metformin Drug: Placebo
Active Comparator: Sitagliptin	Drug: Metformin Drug: Sitagliptin

Outcome Measures

Primary Outcome Measures

To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment [24 weeks]

Secondary Outcome Measures

To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of sitagliptin added to metformin after 24 weeks of treatment. [24 weeks]
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment. [24 weeks]
To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of sitagliptin added to metformin. [24 weeks]
To evaluate the safety and tolerability of vildagliptin compared to placebo and sitagliptin over 24 weeks of treatment as add-on therapy to metformin in patients with T2DM. [24 weeks]
To evaluate the long-term safety and tolerability of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM. [76 weeks]
To evaluate the body weight change from baseline with vildagliptin compared to placebo and sitagliptin after 24 weeks of treatment as add-on therapy to metformin in patients with T2DM. [24 weeks]
To evaluate the long-term efficacy of vildagliptin compared to sitagliptin over the entire study duration as add-on therapy to metformin in patients with T2DM. [76 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients 18-78 years old inclusive at Visit 1
T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit 1
Patient agreement to maintain same dose of metformin throughout study
HbA1c of ≥ 7.0 and ≤ 9.5 % at Visit 1
Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1

Exclusion Criteria:

Pregnant or nursing (lactating) women
FPG ≥ 270 mg/dL ( ≥ 15.0 mmol/L)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto de Investigaciones Biomedicas	Buenos Aires	Santa Fe	Argentina	3000FNF
2	Grupo Colaborative Rosario	Rosario	Santa Fe	Argentina	S2002OJP
3	Fundación de Estudios Farmacológicos y de Medicamentos	Buenos Aires,		Argentina	C1027AAP
4	Grupo Medico Alem	Buenos Aires		Argentina	B1642DCD
5	DIM Clinical Privada	Buenos Aires		Argentina	B1704ETD
6	Clinica Medica Sin Internacion	Buenos Aires		Argentina	B1824KAJ
7	Universitaetsklinik Graz medizinische Universitaetsklinik;	Graz		Austria	8036
8	LKH Salzburg Landesklinik fuer Innere Medizin I	Salzburg		Austria	5020
9	Kindlergasse 4	Wiener Neustadt		Austria	2700
10	Kindlergasse 4	Wiener Neustadt		Austria
11	Millergasse 7	Wien		Austria	1060
12	Hanusch Krankenhaus 1. Med. Abteilung und Nephrodepartment	Wien		Austria	1140
13	Private Practice Diabetology (Dr. Coucke)	Sint-Gillis-Waas	Sint-Niklaasstraat 117	Belgium	9170
14	Private Practice Cardiology (Dr. Hollanders)	De Pinte		Belgium	9840
15	Private Practice (Vernijns)	Genk		Belgium	3600
16	Private Practice (Dr. De Meulemeester)	Gozee		Belgium	6534
17	Huisartsenpraktijk Hygeia	Hasselt		Belgium	3500
18	Private Practice (Dr. Jaak Mortelmans)	Oostham		Belgium	3945
19	Lihavuustutkimusyksikkö	Helsinki		Finland	2 A 2 00270
20	Mehiläinen Töölö Diabetesklinikka	Helsinki		Finland	47 A 00260
21	Terveystalo Kuopio	Kuopio		Finland	70100
22	Mehiläinen Lahti	Lahti		Finland	6 C 15110
23	ODL Terveys Oy, Tutkimusyksikkö,	Oulu		Finland	90100
24	Mehiläinen Riihimäki	Riihimäki		Finland	11130
25	Terveystalo Tampereen työterveys Kalmar	Tampere		Finland	33900
26	Myyrmäen terveysasema	Vantaa		Finland	01600
27	Internistische Gemeinschaftspraxis Nagel, Dietlein & Hunstiger	Augsburg		Germany	86150
28	Praxis Dr. Med. Kurt Rack	Augsburg		Germany	86150
29	Gemeinschaftspraxis S. Maxeiner/Dr. Behr/S. Rupprecht	Bad Kreuznach		Germany	55545
30	Klinische Forschung Berlin-Buch	Berlin		Germany	10117
31	Praxis Dr. Med. Ulrike Venschott-Jordan	Berlin		Germany	12247
32	Praxis Dr. Med. Monika Kiper	Berlin		Germany	12347
33	Praxis Dr. Med. Christina Bondke	Berlin		Germany	13189
34	Bibertal Klinik	Bibertal		Germany	89346
35	Gemeinschaftspraxis Dr. med. Ali Boustani	Diez		Germany	65582
36	Facharzt fuer Allgemeinmedizin	Dorsten		Germany	46282
37	Praxis Dr. Med. Anwar Ansari	Einbeck		Germany	37574
38	Hausaerzte am Stern Dr. Med. Blume / Dr. Med. Garanin	Essen		Germany	45130
39	Praxis Dr. Med. Roland Kutzke	Essen		Germany	45144
40	Praxis Dr. Med. Thorsten Rau	Essen		Germany	45276
41	Praxis Dr. Med. Joerg Luedemann / Facharzt fuer Innere Medizin - Diabetologie	Falkensee		Germany	14612
42	Praxis Dr. Med. Daniela Freise	Frankfurt		Germany	60599
43	Dial.-Med. Kerstin Steinbach	Freital		Germany	01705
44	Gemeinschaftspraxis	Fulda		Germany	36037
45	Praxis Dr. Med. Wolfgang Krause	Grimma		Germany	04668
46	Krankenhaus Hagenow, Innere Medizin	Hagenow		Germany	19230
47	MVZ-medicum Hamburg	Hamburg		Germany	20097
48	Diabetes-Zentrum Wandsbek	Hamburg		Germany	22041
49	Gemeinschaftspraxis Dr. Grüneberg, Dr.Mehring, Bitterer-Tölle	Herne		Germany	44653
50	Praxis Dr. Med. Helmut Anderten	Hildesheim		Germany	31139
51	Praxis Dr. Med. Juergen Landschulze	Kahla		Germany	07768
52	Praxis Dr. Med. Julia Chevts	Karlsruhe		Germany	76199
53	Praxis Dr. Med. Hans-Helmut Seibert	Kassel		Germany	34125
54	Praxis Dr. Med. Claudia Ulbrich	Koeln		Germany	50823
55	Dres. Klein/Minnich	Kuenzing		Germany	94550
56	Praxis Dr. Med. Birgit Hoene	Leipzig		Germany
57	Pro Scientia med	Luebeck		Germany	23562
58	Diabetes Schwerpunktpraxis	Meissen		Germany	01662
59	Praxis Dres. Prohaska / Lindner	Muehldorf		Germany	84453
60	Praxis Dr. Med. Claus-Michael Grimm	Muenchen		Germany	81373
61	Praxis Dr. Fischer & Dr. Keuthage	Muenster		Germany	48153
62	Gemeinschaftspraxis Dr. Uwe Böckmann/Dr. med. Maren Molkewehrum	Neumunster		Germany	24534
63	Praxis Dr. Med. Joachim Etter	Oberhausen		Germany	46049
64	IkFE Studiencenter Potsdam GMBH i.G.	Potsdam		Germany	14469
65	Diabetes Center Quakenbrueck	Quakenbrueck		Germany	49610
66	Praxis Dr. Altwicker, Dr. Kanis	Reinfeld		Germany	23858
67	Praxis Dr. Med. Ulrich Aigner	Rothenburg		Germany
68	Praxis Dr. Med. Sabine Sedl	Schoenberg		Germany	23923
69	Dres. Hiltensperger & Schaal	Schrobenhausen		Germany	86529
70	Praxis Hans-Joachim Herrmann/Dr. med. B. Bauer	Schwabenheim		Germany	55270
71	Praxis Dr. Med. Ottmar Herfert	Stuttgart		Germany	70469
72	Praxis Dr. Med. Doru Popa	Veitsbronn		Germany	90587
73	Gemeinschaftspraxis Gerhard Steinmaier und Dr. Med. Werner Bauer	Viernheim		Germany	68519
74	Gemeinschaftspraxis Sauter	Wangen		Germany	88239
75	Praxis Dr. Med. Rudolf Matthias Remppis	Weissenhorn		Germany	89264
76	Praxis Dr. Med. Peter Genthner	Welzheim		Germany	73642
77	Gemeinschaftspraxis Dr. med. Reinhold Schneider und Christine Schneider	Wetzlar		Germany	35584
78	Laiko General Hospital,	Athens		Greece	GR11527
79	Lamia General Hospital	Larisa		Greece	GR 35100
80	Papageorgiou General Hospital	Thessaloniki		Greece	GR56403
81	Clínica y Hospital Colón del Paciente Diabético	Guatemala City		Guatemala	01001
82	Endonutri S.A	Guatemala City		Guatemala	01010
83	Clínica y Hospital Colón del Paciente Diabético	Guatemala City		Guatemala	11-49
84	Clinica Dr. Erick Turcios	Guatemala City		Guatemala	Oficina 1114
85	Endonutri S. A.	Guatemala City		Guatemala	Oficina 909
86	Clinica Dr. Sergio Bran	Guatemala City		Guatemala
87	Szent Margit Hospita	Budapest		Hungary	1032
88	Károlyi Sándor Hospital	Budapest		Hungary	1041
89	Szent Imre Hospital	Budapest		Hungary	1115
90	Konszenzusplusz Kft.	Csongrád		Hungary	6640
91	Petz Aladar Hospital	Győr		Hungary	9023
92	Jósa Andras Hospital	Nyíregyháza		Hungary
93	Szte-Áok I	Szeged		Hungary	6720
94	Balassa Janos Hospital	Szekszárd		Hungary	7100
95	Zala Megyei Hospital	Zalaegerszeg		Hungary	8900
96	Manipal Hospital,	Bangalore	Karantaka	India	560 017
97	Health and Research Centre	Trivandrum	Kerela	India	695 001
98	Diabetes Thyroid Hormone Research Institute Pvt Ltd.	Indore	Madhya Pradesh	India	452001
99	Madras Diabetes Research Foundation	Chennai	Tamil Nadu	India	500 082
100	M. V. Hosp for Diabetes P. Ltd. 4,	Chennai		India	13
101	Medicity Hospital	Hyderabaad		India	500 036
102	Nizam's institute of medical sciences,	Hyderabaad		India	500 082
103	S. R. Kalla Memorial gastro and general hosp,	Jaipur		India	302001
104	Christian Medical College,	Vellore		India	P. O. Box. No. 3.
105	Maccabi Healthcare Services	Rishon Le Zion		Israel	75650
106	Ziv Medical Center	Safed		Israel	13100
107	U.O.C. di Diabetologia e Malattie Metaboliche	Arenzano		Italy
108	U.S.C. di Endocrinologia (Ingresso 13 - piano 2) Dip. di Medicina	Bergamo		Italy
109	U.O.C. Diabetologia Endocrinologia Dip. Medico	Campobasso		Italy
110	U.O. Medicina Generale	Casorate Primo		Italy
111	I Divisione Medicina	Catania		Italy
112	U.O. Malattie Metaboliche e Diabetologia	Chieri		Italy
113	U.O.C. di Medicina d'Urgenza e Pronto Soccorso	Cosenza		Italy
114	Servizio Diabetologia, SOD Cardiologia Geriatrica - D.A.I. del Cuore e dei Vasi	Firenze		Italy
115	Centro Diabetologico Malattie Metaboliche	Mercato San Severino		Italy
116	Divisione Malattie Metaboliche e Diabetologia	Milano		Italy
117	S. Semplice Dip. di Endocrinologia e Diabetologia Dip. di Medicina Interna	Milano		Italy
118	U.O. Medicina II - Dip. Medicina Interna	Milano		Italy
119	Unità Cardio-Metabolica e Trials Clinici Dipartimento di Medicina Interna	Milano		Italy
120	U.O. Diabetologia	Olbia		Italy
121	Centro per l'Aterosclerosi Dip. di Medicina Interna	Roma		Italy
122	U.O. Endocrinologia e Diabetologia	Roma		Italy
123	U.O.C. di Diabetologia c/o AUSL ROMA B - Sede Territoriale	Roma		Italy
124	U.O.C. di Medicina Interna B - BMI02 Dip. Scienze Cliniche - II Clinica Medica	Roma		Italy
125	S. S. di Diabetologia Dip. Med. Interna e Malattie Metaboliche	Siena		Italy
126	S.C. Prevenzione-Riabilitazione Cardiologica presso ex-Dispensario	Vibo Valentia		Italy
127	Eulji General Hospital	Seoul		Korea, Republic of
128	Kangbuk Samsung Medical center	Seoul		Korea, Republic of
129	Korea University Guro Hospital	Seoul		Korea, Republic of
130	The Catholic University of Korea Holy Family Hospital	Seoul		Korea, Republic of
131	Ajou university hospital	Suwon		Korea, Republic of
132	Daugavpils Regional Hospital	Daugavpils		Latvia	5417
133	Primary Health Centre of Jaunliepaja	Liepaja		Latvia	3401
134	Private practice of endocrinology	Ogre		Latvia	5001
135	Center of Endocrinology	Riga		Latvia	1002
136	Riga Outpatient Clinic "Dziednieciba"	Riga		Latvia	1057
137	Talsi Clinical Hospital	Talsi		Latvia	3201
138	Endocrinology Department of Vidzemes Hospital	Valmiera		Latvia	4201
139	JSC "Klinikiniai sprendimai"	Alytus		Lithuania	63257
140	Kaunas District Hospital	Kaunas		Lithuania	45130
141	Kaunas Silainiai Outpatient Clinic	Kaunas		Lithuania	48259
142	Kaunas Medical University Hospital	Kaunas		Lithuania	50009
143	Kaunas Dainavos Outpatient Clinic	Kaunas		Lithuania	51270
144	Vilnius University Hospital Santariskiu Clinics	Vilnius		Lithuania	08661
145	Private Endocrinology Clinic	Vilnius		Lithuania	09112
146	Comité Bioetico para la Investigación Clínica S.C.	Mexico City	Durango	Mexico	03300
147	Unidad Metabolica y Cardiovascular S.C.	Cuernavaca	Morelos.	Mexico
148	Clínica Eugenio Sue	Mexico City	Polanco Chapultepec	Mexico	11550
149	Clínica de Diabetes de la Secretaria de Salud de Durango	Durango		Mexico	34070
150	Arke Estudios Clinicos S.A. de C.V.	Mexico City		Mexico	06700
151	Flattum legesenter	Hønefoss		Norway	3503
152	Randesund Helsesenter	Kristiansand		Norway
153	Sinsenklinikken	Oslo		Norway	0580
154	Oslo Universitetssykehus	Oslo		Norway
155	Hinnastrekanten legekontor	Stavanger		Norway	4020
156	Vennesla legesenter	Vennesla		Norway
157	Clinica San Miguel	Arequipa		Peru
158	Clinica Geriatrica Militar	Lima		Peru
159	Clinica San Borja	LIma		Peru
160	Clinica Senor de los Milagros	Lima		Peru
161	Hospital Nacional Cayetano Heredia	Lima		Peru
162	Hospital Nacional Guillermo Almenara Irigoyen	Lima		Peru
163	Bydgoskie Centrum Diabetologii i Endokrynologii	Bydgoszcz		Poland	85 822
164	NZOZ "Specjalista" Sp z o. o.	Kutno		Poland	99 300
165	Oddzial Chorob Wewnetrznych	Mielec		Poland	39 300
166	Poradnia Lekarza Rodzinnego	Poznan		Poland	60 521
167	Poznański Ośrodek Medyczny "NOVAMED"	Poznań		Poland	60 773
168	CMI Cardiologie "Dr. Pop Calin Florin"	Baia Mare		Romania	ap. 72
169	"C. I. Parhon" Endocrinology Institute	Bucharest		Romania	district 1
170	Medical Centre "Sanatatea Ta" SRL	Bucharest		Romania	district 2
171	Medical Practice SRL	Oradea		Romania	ap. 3
172	Anamed SRL	Oradea		Romania	ap. 5
173	Emergency County Hospital Ploiesti	Ploiesti		Romania	no. 100
174	Policlinica "Dr. Citu"	Timisoara		Romania	no. 27
175	MEDISPEKTRUM s.r.o,	Bratislava	Slovak Republic	Slovakia	811 02
176	.Interna klinika, FN J.A. Reimana	Presov	Slovak Republic	Slovakia	081 81
177	Diabetologicka ambulancia,	Bratislava	Slovakia Republic	Slovakia	81272
178	Diabetologicka ambulancia	Kosice	Slovakia Republic	Slovakia	040 01
179	Diabetologicka ambulancia,	Lucenec	Slovakia Republic	Slovakia	984 01
180	NZZ Diabetologicka ambulancia	Nove Zamky	Slovakia Republic	Slovakia	940 01
181	Diabetes centrum s.r.o	Trencin	Slovakia Republic	Slovakia	911 01
182	Diabetologicka ambulancia,	Zilina	Slovakia Republic	Slovakia	010 01
183	Diametabol.s.r.o.,	Bratislava		Slovakia	821 07
184	MUDr. Margita Kiripolska s.r.o	Povazska Bystrica		Slovakia	017 01
185	Ambulatorio Militar Tipo III Paramacay. Avenida Universidad. Sector Santa Ana. Naguanagua.	Valencia	Carabobo.	Venezuela
186	Hospital Militar Dr Carlos Arvelo. Final Av. José Angel Lamas. Servicio de Endocrinología.	Caracas.		Venezuela	Piso 4. Urb.
187	Hospital Dr Miguel Perez Carreño. Servicio de Endocrinología. Sotano.	Caracas		Venezuela