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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vildagliptin + metformin | Experimental |
| |
| metformin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin + metformin | Drug |
| ||
| metformin |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| FPG reduction | 24 weeks | |
| Safety and tolerability | 24 weeks | |
| Body weight change from baseline |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pine Bluff | Arkansas | 71603 | United States | |||
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| Label | URL |
|---|---|
| Click here for more information on the clinical study | View source |
| Results for CLMF237A2309 from the Novartis Clinical Trials website | View source |
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1000 bid metformin |
|
| 24 weeks |
| Changes in the fasting lipid profile | 24 weeks |
| Long Beach |
| California |
| 90806 |
| United States |
| Denver | Colorado | 80209 | United States |
| Bangor | Maine | 04401 | United States |
| Billings | Montana | 59102 | United States |
| Novartis Investigative Site | New Brunswick | New Jersey | 08903 | United States |
| Trenton | New Jersey | 08611 | United States |
| Wilmington | North Carolina | 28409 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Uniontown | Pennsylvania | United States |
| Taylors | South Carolina | 29687 | United States |
| Houston | Texas | 77023 | United States |
| Houston | Texas | 77074 | United States |
| Houston | Texas | 77081 | United States |
| Norfolk | Virginia | 23510 | United States |
| Wenatchee | Washington | 98801 | United States |
| Cabinet d'Endocrinologie-Maladies Métaboliques | Annecy | 74000 | France |
| Service Endocrinologic & Metabolisme | Paris | 75013 | France |
| Polycliniques des minguettes | Vénissieux | 69200 | France |
| Hausärztliche Praxis | Aschaffenburg | 63739 | Germany |
| Klinische Forschung Berlin Mitte GmbH | Berlin | 10117 | Germany |
| AVK | Berlin | 12157 | Germany |
| Gemeinschaftspraxis | Celle | 29221 | Germany |
| Malteser KM | Duisburg | 42259 | Germany |
| Untertrintroper Hausarztzentrum | Essen | 45359 | Germany |
| Gefrees | 95482 | Germany |
| Diabeteszentrum Billstedt/Horn | Hamburg | 22119 | Germany |
| Diabetologische Schwerpunktpraxis | Hamburg | 22119 | Germany |
| St. Elisabeth Krankenhaus Leipzig | Leipzig | 04229 | Germany |
| Diabetes-Schwerpunktpraxis Studienambulanz | Leipzig | 04257 | Germany |
| Institut für Diabetes-forschung Münster | Münster | 48145 | Germany |
| Praxis Dr. Alawi | Saarlouis | 66740 | Germany |
| DDT | Siegen | 57072 | Germany |
| Diabetologische Schwerpunktpraxis | Sinsheim | 74889 | Germany |
| Praxis | Wangen | 88239 | Germany |
| Europ-Med Orvosi Szolgaltato Kft | Budaörs | 2040 | Hungary |
| Synexus Magyarorszag | Budapest | 1036 | Hungary |
| Uzsoki Hospital | Budapest | 1145 | Hungary |
| Budapest | Hungary |
| Kenezy Hospital | Debrecen | Hungary |
| Gyngyosi Korhaz Kft | Gyöngyös | 3200 | Hungary |
| Petz Aladar County | Győr | 9024 | Hungary |
| Selye Janos Korhaz es Rendelointezet | Komárom | 2900 | Hungary |
| DIAPED Kft., MRC | Meggyesalja U. | 122 | Hungary |
| Josa Andras Teaching Hospital | Nyíregyháza | 4400 | Hungary |
| Vas Megyei Markuscvszky Lajos Korhaz | Szombathely | 9700 | Hungary |
| Zala County Hospital | Zalaegerszeg | Hungary |
| NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok | Bialystok | 15-435 | Poland |
| Gdanska Poradnia Cukrzycowa | Gdansk | 80-858 | Poland |
| Gabinet Kardiologiczny Mediplus | Gdynia | 81-423 | Poland |
| NZOZ "Esculap" S.C. | Gniewkowo | 88-140 | Poland |
| SZPZOZ Szpital Zachodni im. Jana Pawla II | Grodzisk Mazowiecki | 05-825 | Poland |
| NZOZ Terapia Optima | Katowice | 40-752 | Poland |
| Instytut Cantrum Zdrowia Matki Polki | Lodz | 93-338 | Poland |
| NZOZ Special-Med | Lublin | 20-044 | Poland |
| Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza | Poznan | 60-569 | Poland |
| Lecznica Prosen-SMO NZOZ | Warsaw | 01-231 | Poland |
| Centrum Leczenia Chorob Cywilizacyjnych | Warsaw | 02-777 | Poland |
| NZCZ Regionalna Poradnia Diabetologiczna | Wroclaw | 50-127 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 | Wroclaw | 50-367 | Poland |
| Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM | Zabrze | 41-800 | Poland |
| Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy | Łęczyca | 99-100 | Poland |
| Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca | Łęczyca | 99-100 | Poland |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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