Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00728351

Collaborator

(none)

317

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

Brief Summary

The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: vildagliptin + metformin Drug: metformin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

317 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vildagliptin + metformin	Drug: vildagliptin + metformin
Active Comparator: metformin	Drug: metformin 1000 bid metformin

Arm

Intervention/Treatment

Experimental: vildagliptin + metformin

Drug: vildagliptin + metformin

Active Comparator: metformin

Drug: metformin

1000 bid metformin

Outcome Measures

Primary Outcome Measures

HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy [24 weeks]

Secondary Outcome Measures

FPG reduction [24 weeks]
Safety and tolerability [24 weeks]
Body weight change from baseline [24 weeks]
Changes in the fasting lipid profile [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

History of T2DM treated with Metformin

Exclusion Criteria:

FPG >= 260 mg/dL (14.4mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Pine Bluff	Arkansas	United States	71603
2		Long Beach	California	United States	90806
3		Denver	Colorado	United States	80209
4		Bangor	Maine	United States	04401
5		Billings	Montana	United States	59102
6	Novartis Investigative Site	New Brunswick	New Jersey	United States	08903
7		Trenton	New Jersey	United States	08611
8		Wilmington	North Carolina	United States	28409
9		Oklahoma City	Oklahoma	United States	73104
10		Uniontown	Pennsylvania	United States
11		Taylors	South Carolina	United States	29687
12		Houston	Texas	United States	77023
13		Houston	Texas	United States	77074
14		Houston	Texas	United States	77081
15		Norfolk	Virginia	United States	23510
16		Wenatchee	Washington	United States	98801
17	Cabinet d'Endocrinologie-Maladies Métaboliques	Annecy		France	74000
18	Service Endocrinologic & Metabolisme	Paris		France	75013
19	Polycliniques des minguettes	Venissieux		France	69200
20	Hausärztliche Praxis	Aschaffenburg		Germany	63739
21	Klinische Forschung Berlin Mitte GmbH	Berlin		Germany	10117
22	AVK	Berlin		Germany	12157
23	Gemeinschaftspraxis	Celle		Germany	29221
24	Malteser KM	Duisburg		Germany	42259
25	Untertrintroper Hausarztzentrum	Essen		Germany	45359
26		Gefrees		Germany	95482
27	Diabeteszentrum Billstedt/Horn	Hamburg		Germany	22119
28	Diabetologische Schwerpunktpraxis	Hamburg		Germany	22119
29	St. Elisabeth Krankenhaus Leipzig	Leipzig		Germany	04229
30	Diabetes-Schwerpunktpraxis Studienambulanz	Leipzig		Germany	04257
31	Institut für Diabetes-forschung Münster	Münster		Germany	48145
32	Praxis Dr. Alawi	Saarlouis		Germany	66740
33	DDT	Siegen		Germany	57072
34	Diabetologische Schwerpunktpraxis	Sinsheim		Germany	74889
35	Praxis	Wangen		Germany	88239
36	Synexus Magyarorszag	Budapest		Hungary	1036
37	Uzsoki Hospital	Budapest		Hungary	1145
38		Budapest		Hungary
39	Europ-Med Orvosi Szolgaltato Kft	Budaörs		Hungary	2040
40	Kenezy Hospital	Debrecen		Hungary
41	Gyngyosi Korhaz Kft	Gyongyos		Hungary	3200
42	Petz Aladar County	Györ		Hungary	9024
43	Selye Janos Korhaz es Rendelointezet	Komarom		Hungary	2900
44	DIAPED Kft., MRC	Meggyesalja U.		Hungary	122
45	Josa Andras Teaching Hospital	Nyiregyhaza		Hungary	4400
46	Vas Megyei Markuscvszky Lajos Korhaz	Szombathely		Hungary	9700
47	Zala County Hospital	Zalaegerszeg		Hungary
48	NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok	Bialystok		Poland	15-435
49	Gdanska Poradnia Cukrzycowa	Gdansk		Poland	80-858
50	Gabinet Kardiologiczny Mediplus	Gdynia		Poland	81-423
51	NZOZ "Esculap" S.C.	Gniewkowo		Poland	88-140
52	SZPZOZ Szpital Zachodni im. Jana Pawla II	Grodzisk Mazowiecki		Poland	05-825
53	NZOZ Terapia Optima	Katowice		Poland	40-752
54	Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy	Leczyca		Poland	99-100
55	Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca	Leczyca		Poland	99-100
56	Instytut Cantrum Zdrowia Matki Polki	Lodz		Poland	93-338
57	NZOZ Special-Med	Lublin		Poland	20-044
58	Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza	Poznan		Poland	60-569
59	Lecznica Prosen-SMO NZOZ	Warszawa		Poland	01-231
60	Centrum Leczenia Chorob Cywilizacyjnych	Warszawa		Poland	02-777
61	NZCZ Regionalna Poradnia Diabetologiczna	Wroclaw		Poland	50-127
62	Samodzielny Publiczny Szpital Kliniczny Nr 1	Wroclaw		Poland	50-367
63	Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM	Zabrze		Poland	41-800