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%)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00728351
First received: July 31, 2008
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: vildagliptin + metformin Drug: metformin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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. |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- FPG reduction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Body weight change from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Changes in the fasting lipid profile [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 317 |
| Study Start Date: | June 2008 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: vildagliptin + metformin | Drug: vildagliptin + metformin |
| Active Comparator: metformin |
Drug: metformin
1000 bid metformin
|
Eligibility| Ages Eligible for Study: | 18 Years to 78 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728351
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Hide Study LocationsLocations
| United States, Arkansas | |
| Pine Bluff, Arkansas, United States, 71603 | |
| United States, California | |
| Long Beach, California, United States, 90806 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80209 | |
| United States, Maine | |
| Bangor, Maine, United States, 04401 | |
| United States, Montana | |
| Billings, Montana, United States, 59102 | |
| United States, New Jersey | |
| Novartis Investigative Site | |
| New Brunswick, New Jersey, United States, 08903 | |
| Trenton, New Jersey, United States, 08611 | |
| United States, North Carolina | |
| Wilmington, North Carolina, United States, 28409 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Uniontown, Pennsylvania, United States | |
| United States, South Carolina | |
| Taylors, South Carolina, United States, 29687 | |
| United States, Texas | |
| Houston, Texas, United States, 77081 | |
| Houston, Texas, United States, 77074 | |
| Houston, Texas, United States, 77023 | |
| United States, Virginia | |
| Norfolk, Virginia, United States, 23510 | |
| United States, Washington | |
| Wenatchee, Washington, United States, 98801 | |
| France | |
| Cabinet d'Endocrinologie-Maladies Métaboliques | |
| Annecy, France, 74000 | |
| Service Endocrinologic & Metabolisme | |
| Paris, France, 75013 | |
| Polycliniques des minguettes | |
| Venissieux, France, 69200 | |
| Germany | |
| Hausärztliche Praxis | |
| Aschaffenburg, Germany, 63739 | |
| AVK | |
| Berlin, Germany, 12157 | |
| Klinische Forschung Berlin Mitte GmbH | |
| Berlin, Germany, 10117 | |
| Gemeinschaftspraxis | |
| Celle, Germany, 29221 | |
| Malteser KM | |
| Duisburg, Germany, 42259 | |
| Untertrintroper Hausarztzentrum | |
| Essen, Germany, 45359 | |
| Gefrees, Germany, 95482 | |
| Diabeteszentrum Billstedt/Horn | |
| Hamburg, Germany, 22119 | |
| Diabetologische Schwerpunktpraxis | |
| Hamburg, Germany, 22119 | |
| St. Elisabeth Krankenhaus Leipzig | |
| Leipzig, Germany, 04229 | |
| Diabetes-Schwerpunktpraxis Studienambulanz | |
| Leipzig, Germany, 04257 | |
| Institut für Diabetes-forschung Münster | |
| Münster, Germany, 48145 | |
| Praxis Dr. Alawi | |
| Saarlouis, Germany, 66740 | |
| DDT | |
| Siegen, Germany, 57072 | |
| Diabetologische Schwerpunktpraxis | |
| Sinsheim, Germany, 74889 | |
| Praxis | |
| Wangen, Germany, 88239 | |
| Hungary | |
| Budapest, Hungary | |
| Synexus Magyarorszag | |
| Budapest, Hungary, 1036 | |
| Uzsoki Hospital | |
| Budapest, Hungary, 1145 | |
| Europ-Med Orvosi Szolgaltato Kft | |
| Budaörs, Hungary, 2040 | |
| Kenezy Hospital | |
| Debrecen, Hungary | |
| Gyngyosi Korhaz Kft | |
| Gyongyos, Hungary, 3200 | |
| Petz Aladar County | |
| Györ, Hungary, 9024 | |
| Selye Janos Korhaz es Rendelointezet | |
| Komarom, Hungary, 2900 | |
| DIAPED Kft., MRC | |
| Meggyesalja u., Hungary, 122 | |
| Josa Andras Teaching Hospital | |
| Nyiregyhaza, Hungary, 4400 | |
| Vas Megyei Markuscvszky Lajos Korhaz | |
| Szombathely, Hungary, 9700 | |
| Zala County Hospital | |
| Zalaegerszeg, Hungary | |
| Poland | |
| NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok | |
| Bialystok, Poland, 15-435 | |
| Gdanska Poradnia Cukrzycowa | |
| Gdansk, Poland, 80-858 | |
| Gabinet Kardiologiczny Mediplus | |
| Gdynia, Poland, 81-423 | |
| NZOZ "Esculap" S.C. | |
| Gniewkowo, Poland, 88-140 | |
| SZPZOZ Szpital Zachodni im. Jana Pawla II | |
| Grodzisk Mazowiecki, Poland, 05-825 | |
| NZOZ Terapia Optima | |
| Katowice, Poland, 40-752 | |
| Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca | |
| Leczyca, Poland, 99-100 | |
| Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy | |
| Leczyca, Poland, 99-100 | |
| Instytut Cantrum Zdrowia Matki Polki | |
| Lodz, Poland, 93-338 | |
| NZOZ Special-Med | |
| Lublin, Poland, 20-044 | |
| Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza | |
| Poznan, Poland, 60-569 | |
| Centrum Leczenia Chorob Cywilizacyjnych | |
| Warszawa, Poland, 02-777 | |
| Lecznica Prosen-SMO NZOZ | |
| Warszawa, Poland, 01-231 | |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 | |
| Wroclaw, Poland, 50-367 | |
| NZCZ Regionalna Poradnia Diabetologiczna | |
| Wroclaw, Poland, 50-127 | |
| Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM | |
| Zabrze, Poland, 41-800 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00728351 History of Changes |
| Other Study ID Numbers: | CLMF237A2309 |
| Study First Received: | July 31, 2008 |
| Last Updated: | January 2, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Type 2 diabetes, vildagliptin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vildagliptin Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013