VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
Launched by NOVARTIS PHARMACEUTICALS · Feb 3, 2012
Trial Information
Current as of June 06, 2025
Completed
Keywords
ClinConnect Summary
This was a multi-center, double-blind, placebo-controlled, 2-arm, parallel group study with a run-in period and up to 5 years treatment period. Following a screening visit (Visit 1) and a screening period of up to 2 weeks, treatment-naïve patients, meeting all eligibility criteria entered the run-in period at Visit 2.
* Run-in period: At Visit 2, in all eligible patients, metformin treatment was initiated and/or up-titrated. At the end of the 3-week run-in period, patients who were able to tolerate a total dose of at least 1000 mg and up to 2000 mg daily proceeded to randomization and star...
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Type 2 Diabetes Mellitus (T2DM) diagnosed ≤ 24 months ago
- • glycosylated hemoglobin (HbA1c) ≥6.5% and ≤7.5% at Visit 1
- • Treatment-naïve.
- • Body mass index (BMI) ≥22 and ≤40 kg/m2 at Visit 1
- Key Exclusion Criteria:
- • Pregnant or nursing (lactating) women
- • Fasting plasma glucose (FPG) ≥ 270 mg/dL (≥ 15.0 mmol/L)
- • Previous or current participation in any vildagliptin clinical study.
- • History of hypersensitivity to dipeptidyl peptidase-4 (DPP-4) inhibitors.
- • Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
- • Donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period.
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durango, , Mexico
Wien, , Austria
Duesseldorf, , Germany
Roma, Rm, Italy
Seoul, Korea, Korea, Republic Of
Milano, Mi, Italy
Sao Paulo, Sp, Brazil
Essen, , Germany
Oslo, , Norway
Barcelona, Catalunya, Spain
Taichung, , Taiwan
Taoyuan, , Taiwan
Hong Kong, , Hong Kong
Taipei, , Taiwan
Dresden, , Germany
Pasay City, , Philippines
Presov, , Slovakia
Essen, , Germany
Baranquilla, , Colombia
Milano, Mi, Italy
Izmir, , Turkey
São Paulo, Sp, Brazil
Roma, Rm, Italy
Bratislava, Slovak Republic, Slovakia
Cape Town, , South Africa
Adana, , Turkey
Buenos Aires, , Argentina
Cordoba, , Argentina
Wien, , Austria
Belem, Pa, Brazil
Bogotá, , Colombia
Aschaffenburg, , Germany
Neuwied, , Germany
Budapest, , Hungary
Campobasso, Cb, Italy
Arenzano, Ge, Italy
Casorate Primo, Pv, Italy
Spikkestad, , Norway
Cercado De Lima, Lima, Peru
San Isidro, Lima, Peru
San Martin De Porres, Lima, Peru
Zilina, Slovak Republic, Slovakia
Durban, , South Africa
Gauteng, , South Africa
Barcelona, Cataluña, Spain
Kerava, , Finland
Tampere, , Finland
Moscow, , Russian Federation
Antalya, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Montichiari, Bs, Italy
Bogotá, Cundinamarca, Colombia
Petrozavodsk, , Russian Federation
N.Novgorod, , Russian Federation
Quezon City, Metro Manila, Philippines
Kahramanmaras, , Turkey
Cartagena, Bolivar, Colombia
Santo Domingo, Republica Dominicana, Dominican Republic
Pune, Maharashtra, India
Aguascalientes, , Mexico
Querétaro, , Mexico
Trujillo, La Libertad, Peru
Wroclaw, , Poland
Zabrze, , Poland
Ryazan, , Russian Federation
Saratov, , Russian Federation
Corrientes, , Argentina
Taipei, Taiwan, Roc, Taiwan
Ludwigshafen, , Germany
Levice, , Slovakia
Fulda, , Germany
Kamp Lintfort, , Germany
Indore, Madhya Pradesh, India
Penza, , Russian Federation
St. Petersburg, , Russian Federation
Banska Bystrica, , Slovakia
Bucuresti, , Romania
Hongkong, , Hong Kong
Timisoara, , Romania
Plovdiv, , Bulgaria
Szeged, , Hungary
Kfar Saba, , Israel
Chandigarh, , India
Sofia, , Bulgaria
Wangen, , Germany
Eger, , Hungary
Mexico D.F, Distrito Federal, Mexico
San Juan City, , Philippines
Alberton, , South Africa
Pretoria, , South Africa
Smolensk, , Russian Federation
Suwon, Gyeonggi Do, Korea, Republic Of
Poznan, , Poland
Arequipa, , Peru
Praha, , Czechia
Veszprem, , Hungary
Sefad, , Israel
Saint Petersburg, , Russian Federation
Lahti, Suomi, Finland
Nové Zámky, , Slovakia
Kota Bahru, Kelantan, Malaysia
Kuala Lumpur, , Malaysia
Csongrad, , Hungary
Uijeongbu Si, Gyeonggi Do, Korea, Republic Of
Trebisov, Slovak Republic, Slovakia
Caba, Buenos Aires, Argentina
Saku, , Estonia
Zalaegerszeg, Zala, Hungary
Budapest, , Hungary
Daugavpils, , Latvia
Kaunas, Ltu, Lithuania
Sabinov, , Slovakia
Brookvale, New South Wales, Australia
Morayfield, Queensland, Australia
San Isidro, Buenos Aires, Argentina
Woy Woy, New South Wales, Australia
Fortaleza, Ce, Brazil
Brasilia, Df, Brazil
Goiania, Go, Brazil
Curitiba, Pr, Brazil
Porto Alegre, Rs, Brazil
Mogi Das Cruzes, Sp, Brazil
Gabrovo, , Bulgaria
Kazanlak, , Bulgaria
Razgrad, , Bulgaria
Ruse, , Bulgaria
Smolian, , Bulgaria
Bogota, Cundinamarca, Colombia
Pisek, Czech Republic, Czechia
Prague 5, Czech Republic, Czechia
Brandys Nad Labem, , Czechia
Praha, , Czechia
Tallinn, , Estonia
Kouvola, , Finland
Hainstadt, Hainburg, Germany
Esslingen Am Neckar, , Germany
Gelnhausen, , Germany
Koeln, , Germany
Saint Ingbert Oberwuerzbach, , Germany
Clinica, , Guatemala
Guatemala City, , Guatemala
Kalocsa, , Hungary
New Delhi, Delhi, India
Bangalore, Karnataka, India
Kochi, Kerala, India
Jaipur, Rajasthan, India
Chennai, Tamil Nadu, India
Heifa, , Israel
Jerusalem, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Tel Giborim, Holon, , Israel
Incheon, Gyeonggi Do, Korea, Republic Of
Seoul, Korea, Korea, Republic Of
Daejeon, , Korea, Republic Of
Jelgava, Lv, Latvia
Liepaja, Lv, Latvia
Ogre, Lv, Latvia
Riga, Lv, Latvia
Talsi, Lv, Latvia
Vilnius, Lt, Lithuania
Jonava, , Lithuania
Ciudad De Mexico, Distrito Federal, Mexico
México, Distrito Federal, Mexico
Cuautla, Morelos, Mexico
Cuernavaca, Morelos, Mexico
Distrito Federal, , Mexico
Enebakk, , Norway
Fetsund, , Norway
Honefoss, , Norway
Panama City, , Panama
Chorrillos, Lima, Peru
Magdalena, Lima, Peru
Marikina, Metro Manila, Philippines
Marikina City, , Philippines
Pasig City, , Philippines
Poznan, , Poland
Oradea, Bihor, Romania
Ploiesti, Jud. Prahova, Romania
Bucharest, , Romania
St Petersburg, , Russian Federation
Bratislava, Slovak Republic, Slovakia
Kosice, Slovak Republic, Slovakia
Lucenec, Slovak Republic, Slovakia
Namestovo, Slovak Republic, Slovakia
Roznava, Slovak Republic, Slovakia
Sala, Slovak Republic, Slovakia
Sered, , Slovakia
Sturovo, , Slovakia
Johannesburg, , South Africa
Sant Adria Del Besos, Barcelona, Spain
Santa Coloma De Gramanet, Barcelona, Spain
Hsintien, , Taiwan
Denizli, , Turkey
Diskapi / Ankara, , Turkey
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials