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%)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00728351
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 317
- History of T2DM treated with Metformin
- FPG >= 260 mg/dL (14.4mmol/L)
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vildagliptin + metformin vildagliptin + metformin - metformin metformin -
- Primary Outcome Measures
Name Time Method HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy 24 weeks
- Secondary Outcome Measures
Name Time Method Body weight change from baseline 24 weeks Safety and tolerability 24 weeks FPG reduction 24 weeks Changes in the fasting lipid profile 24 weeks
Trial Locations
- Locations (45)
Polycliniques des minguettes
🇫🇷Venissieux, France
Malteser KM
🇩🇪Duisburg, Germany
Diabeteszentrum Billstedt/Horn
🇩🇪Hamburg, Germany
Kenezy Hospital
🇭🇺Debrecen, Hungary
Petz Aladar County
🇭🇺Györ, Hungary
Selye Janos Korhaz es Rendelointezet
🇭🇺Komarom, Hungary
Gdanska Poradnia Cukrzycowa
🇵🇱Gdansk, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
🇵🇱Wroclaw, Poland
Uzsoki Hospital
🇭🇺Budapest, Hungary
Cabinet d'Endocrinologie-Maladies Métaboliques
🇫🇷Annecy, France
Gemeinschaftspraxis
🇩🇪Celle, Germany
Institut für Diabetes-forschung Münster
🇩🇪Münster, Germany
Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy
🇵🇱Leczyca, Poland
NZOZ Special-Med
🇵🇱Lublin, Poland
Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza
🇵🇱Poznan, Poland
Centrum Leczenia Chorob Cywilizacyjnych
🇵🇱Warszawa, Poland
St. Elisabeth Krankenhaus Leipzig
🇩🇪Leipzig, Germany
AVK
🇩🇪Berlin, Germany
DDT
🇩🇪Siegen, Germany
Europ-Med Orvosi Szolgaltato Kft
🇭🇺Budaörs, Hungary
Zala County Hospital
🇭🇺Zalaegerszeg, Hungary
Service Endocrinologic & Metabolisme
🇫🇷Paris, France
Novartis Investigative Site
🇺🇸New Brunswick, New Jersey, United States
Hausärztliche Praxis
🇩🇪Aschaffenburg, Germany
Klinische Forschung Berlin Mitte GmbH
🇩🇪Berlin, Germany
NZOZ "Esculap" S.C.
🇵🇱Gniewkowo, Poland
Untertrintroper Hausarztzentrum
🇩🇪Essen, Germany
Vas Megyei Markuscvszky Lajos Korhaz
🇭🇺Szombathely, Hungary
NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok
🇵🇱Bialystok, Poland
Gabinet Kardiologiczny Mediplus
🇵🇱Gdynia, Poland
Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca
🇵🇱Leczyca, Poland
Diabetologische Schwerpunktpraxis
🇩🇪Sinsheim, Germany
Praxis
🇩🇪Wangen, Germany
SZPZOZ Szpital Zachodni im. Jana Pawla II
🇵🇱Grodzisk Mazowiecki, Poland
Diabetes-Schwerpunktpraxis Studienambulanz
🇩🇪Leipzig, Germany
Praxis Dr. Alawi
🇩🇪Saarlouis, Germany
Gyngyosi Korhaz Kft
🇭🇺Gyongyos, Hungary
DIAPED Kft., MRC
🇭🇺Meggyesalja U., Hungary
Josa Andras Teaching Hospital
🇭🇺Nyiregyhaza, Hungary
Lecznica Prosen-SMO NZOZ
🇵🇱Warszawa, Poland
Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM
🇵🇱Zabrze, Poland
Synexus Magyarorszag
🇭🇺Budapest, Hungary
NZOZ Terapia Optima
🇵🇱Katowice, Poland
Instytut Cantrum Zdrowia Matki Polki
🇵🇱Lodz, Poland
NZCZ Regionalna Poradnia Diabetologiczna
🇵🇱Wroclaw, Poland