Diabetes Mellitus, Type 2 Clinical Trial
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.
| NCT number | NCT00728351 |
| Other study ID # | CLMF237A2309 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | June 2008 |
| Verified date | January 2013 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 317 |
| Est. completion date | |
| Est. primary completion date | February 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 78 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Cabinet d'Endocrinologie-Maladies Métaboliques | Annecy | |
| France | Service Endocrinologic & Metabolisme | Paris | |
| France | Polycliniques des minguettes | Venissieux | |
| Germany | Hausärztliche Praxis | Aschaffenburg | |
| Germany | AVK | Berlin | |
| Germany | Klinische Forschung Berlin Mitte GmbH | Berlin | |
| Germany | Gemeinschaftspraxis | Celle | |
| Germany | Malteser KM | Duisburg | |
| Germany | Untertrintroper Hausarztzentrum | Essen | |
| Germany | Diabeteszentrum Billstedt/Horn | Hamburg | |
| Germany | Diabetologische Schwerpunktpraxis | Hamburg | |
| Germany | Diabetes-Schwerpunktpraxis Studienambulanz | Leipzig | |
| Germany | St. Elisabeth Krankenhaus Leipzig | Leipzig | |
| Germany | Institut für Diabetes-forschung Münster | Münster | |
| Germany | Praxis Dr. Alawi | Saarlouis | |
| Germany | DDT | Siegen | |
| Germany | Diabetologische Schwerpunktpraxis | Sinsheim | |
| Germany | Praxis | Wangen | |
| Hungary | Europ-Med Orvosi Szolgaltato Kft | Budaörs | |
| Hungary | Synexus Magyarorszag | Budapest | |
| Hungary | Uzsoki Hospital | Budapest | |
| Hungary | Kenezy Hospital | Debrecen | |
| Hungary | Gyngyosi Korhaz Kft | Gyongyos | |
| Hungary | Petz Aladar County | Györ | |
| Hungary | Selye Janos Korhaz es Rendelointezet | Komarom | |
| Hungary | DIAPED Kft., MRC | Meggyesalja U. | |
| Hungary | Josa Andras Teaching Hospital | Nyiregyhaza | |
| Hungary | Vas Megyei Markuscvszky Lajos Korhaz | Szombathely | |
| Hungary | Zala County Hospital | Zalaegerszeg | |
| Poland | NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny Bialystok | Bialystok | |
| Poland | Gdanska Poradnia Cukrzycowa | Gdansk | |
| Poland | Gabinet Kardiologiczny Mediplus | Gdynia | |
| Poland | NZOZ "Esculap" S.C. | Gniewkowo | |
| Poland | SZPZOZ Szpital Zachodni im. Jana Pawla II | Grodzisk Mazowiecki | |
| Poland | NZOZ Terapia Optima | Katowice | |
| Poland | Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy | Leczyca | |
| Poland | Zespól Opieki Zdrowotnej w Leczycy, Poradnia Diabetologiczna Leczyca | Leczyca | |
| Poland | Instytut Cantrum Zdrowia Matki Polki | Lodz | |
| 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 | Lecznica Prosen-SMO NZOZ | Warszawa | |
| Poland | NZCZ Regionalna Poradnia Diabetologiczna | Wroclaw | |
| Poland | Samodzielny Publiczny Szpital Kliniczny Nr 1 | Wroclaw | |
| Poland | Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM | Zabrze | |
| United States | Novartis Investigative Site | New Brunswick | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, France, Germany, Hungary, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy | 24 weeks | ||
| Secondary | FPG reduction | 24 weeks | ||
| Secondary | Safety and tolerability | 24 weeks | ||
| Secondary | Body weight change from baseline | 24 weeks | ||
| Secondary | Changes in the fasting lipid profile | 24 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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