VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
A 5-year Study to Compare the Durability of Glycemic Control of a Combination Regimen With Vildagliptin & Metformin Versus Standard-of-care Monotherapy With Metformin, Initiated in Treatment-naïve Patients With Type 2 Diabetes Mellitus
2 other identifiers
interventional
2,004
32 countries
219
Brief Summary
The purpose of this study was to determine whether the initiation of a vildagliptin plus metformin combination regimen would result in more durable glycemic control than metformin monotherapy in treatment-naïve patients with type-2 diabetes mellitus (T2DM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started Mar 2012
Longer than P75 for phase_4 type-2-diabetes-mellitus
219 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2012
CompletedFirst Posted
Study publicly available on registry
February 7, 2012
CompletedStudy Start
First participant enrolled
March 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2019
CompletedResults Posted
Study results publicly available
April 15, 2020
CompletedSeptember 24, 2020
September 1, 2020
7 years
February 3, 2012
March 30, 2020
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Initial Treatment Failure
Treatment failure was defined as two consecutive scheduled visits with HbA1c \>= 7.0% (starting from 13 weeks after randomization) and the time to treatment failure was the number of days from randomization to the second of the consecutive scheduled visits. Participants who discontinued the study for any reason during Period 1 were censored at the date of discontinuation. Participants who remained under the threshold (or whose measurement above the threshold was not confirmed at next scheduled visit) were censored at the date of last study visit.
Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
Secondary Outcomes (7)
Rate of Loss in Glycemic Control During Period 1
Visit 5 (Week 26) to End of Period 1
Rate of Loss in Glycemic Control in HbA1c Over Time During Period 2
From 26 weeks after start of Period 2 to end of Period 2
Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) During Period 1
Visit 5 (Week 26) to End of Period 1
Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) Over Time During Period 2
From 26 weeks after start of Period 2 to end of Period 2
Rate of Loss of Beta Cell Function From Baseline to End of Study
Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
- +2 more secondary outcomes
Study Arms (2)
Vilda 50mg bid + metformin
ACTIVE COMPARATORMetformin + vildagliptin
Placebo + metformin
EXPERIMENTALMetformin + Placebo of vildagliptin
Interventions
One tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food.
Twice daily (bid) regimen during or after meals at the same time as vildagliptin.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (227)
Novartis Investigative Site
CABA, Buenos Aires, C1056ABJ, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1425AGC, Argentina
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San Isidro, Buenos Aires, 1642, Argentina
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CABA, Buenos Aires F.D., C1179AAB, Argentina
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Buenos Aires, C1120AAC, Argentina
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Corrientes, 3400, Argentina
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Córdoba, X5000AAW, Argentina
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Brookvale, New South Wales, 2100, Australia
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Woy Woy, New South Wales, 2256, Australia
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Morayfield, Queensland, 4506, Australia
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Vienna, A-1130, Austria
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Fortaleza, Ceará, 60170-320, Brazil
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Fortaleza, Ceará, 60430-350, Brazil
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Brasília, Federal District, 71625-009, Brazil
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Goiânia, Goiás, 74935-530, Brazil
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Curitiba, Paraná, 80810-040, Brazil
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Belém, Pará, 66073-000, Brazil
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Porto Alegre, Rio Grande do Sul, 90430 001, Brazil
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Mogi das Cruzes, São Paulo, 08780-090, Brazil
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São Paulo, São Paulo, 01224-000, Brazil
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São Paulo, São Paulo, 01244-030, Brazil
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São Paulo, São Paulo, 04023-900, Brazil
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São Paulo, São Paulo, 05403 000, Brazil
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Smolyan, Bulgaria, 4700, Bulgaria
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Gabrovo, 5300, Bulgaria
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Kazanlak, 6100, Bulgaria
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Plovdiv, 4002, Bulgaria
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Razgrad, Bulgaria
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Rousse, 7200, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, Bulgaria
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Bogota, Cundinamarca, 110221, Colombia
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Cartagena, Departamento de Bolívar, Colombia
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Baranquilla, Colombia
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Bogotá, Colombia
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Písek, Czech Republic, 397 01, Czechia
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Prague, Czech Republic, 150 30, Czechia
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Brandýs nad Labem, 250 01, Czechia
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Prague, 149 01, Czechia
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Santo Domingo, Republica Dominicana, Dominican Republic
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Santo Domingo, Dominican Republic
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Saku, 75501, Estonia
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Tallinn, 10117, Estonia
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Tallinn, 11315, Estonia
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Tallinn, 11911, Estonia
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Tallinn, 13415, Estonia
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Lahti, Suomi, 15110, Finland
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Kerava, 04200, Finland
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Kouvola, 45100, Finland
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Tampere, 33100, Finland
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Hainstadt, Hainburg, 63512, Germany
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Aschaffenburg, 63739, Germany
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Cologne, 51069, Germany
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Dresden, 01307, Germany
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Düsseldorf, 40225, Germany
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Essen, 45276, Germany
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Essen, 45329, Germany
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Esslingen am Neckar, 73728, Germany
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Fulda, 36037, Germany
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Gelnhausen, 63571, Germany
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Kamp-Lintfort, 47475, Germany
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Ludwigshafen, 67059, Germany
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Neuwied, 56564, Germany
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Saint Ingbert - Oberwuerzbach, 66386, Germany
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Wangen, 88239, Germany
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Casorate Primo, PV, 27022, Italy
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Daugavpils, LV-5417, Latvia
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Kuala Lumpur, 56000, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Cuautla, Morelos, 62746, Mexico
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Cuernavaca, Morelos, 62250, Mexico
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Aguascalientes, 20230, Mexico
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Distrito Federal, 14000, Mexico
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Durango, 34000, Mexico
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Querétaro, 76000, Mexico
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Enebakk, 1912, Norway
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Fetsund, 1900, Norway
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Hønefoss, 3515, Norway
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Oslo, 0424, Norway
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Spikkestad, 3430, Norway
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Panama City, 0834-01862, Panama
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Panama City, Panama
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Trujillo, La Libertad, Peru
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Chorrillos, Lima region, 09, Peru
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Lima Cercado, Lima region, 01, Peru
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Magdalena, Lima region, 17, Peru
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San Isidro, Lima region, 27, Peru
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San Martín de Porres, Lima region, 31, Peru
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Arequipa, Peru
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Marikina City, National Capital Region, 1810, Philippines
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Quezon City, National Capital Region, 1109, Philippines
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Pasay, Philippines, 1300, Philippines
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Marikina City, 1800, Philippines
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Pasig, 1600, Philippines
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San Juan City, 1500, Philippines
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Poznan, 60-821, Poland
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Poznan, 61-251, Poland
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Poznan, 61-655, Poland
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Wroclaw, 50-349, Poland
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Zabrze, 41-800, Poland
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Oradea, Bihor County, 410001, Romania
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Oradea, Jud. Bihor, 410619, Romania
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Ploieşti, Jud. Prahova, 100097, Romania
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Bucharest, 020045, Romania
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Timișoara, Romania
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Moscow, 101990, Russia
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N.Novgorod, 603126, Russia
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Penza, 440026, Russia
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Petrozavodsk, 185019, Russia
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Ryazan, 390026, Russia
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Saint Petersburg, 194044, Russia
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Saint Petersburg, 194358, Russia
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Saint Petersburg, 198260, Russia
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Saint Petersburg, 199034, Russia
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Saratov, 410012, Russia
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Smolensk, 214019, Russia
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Bratislava, Slovak Republic, 85101, Slovakia
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Košice, Slovak Republic, 04001, Slovakia
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Lučenec, Slovak Republic, 98401, Slovakia
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Námestovo, Slovak Republic, 02901, Slovakia
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Rožňava, Slovak Republic, 04801, Slovakia
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Šaľa, Slovak Republic, 92701, Slovakia
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Trebišov, Slovak Republic, 075 01, Slovakia
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Žilina, Slovak Republic, 010 01, Slovakia
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Banská Bystrica, 974 01, Slovakia
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Košice, 040 01, Slovakia
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Košice, 040 22, Slovakia
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Levice, 934 01, Slovakia
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Nové Zámky, 940 01, Slovakia
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Prešov, 080 01, Slovakia
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Sabinov, 08301, Slovakia
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Sereď, 92601, Slovakia
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Štúrovo, 94301, Slovakia
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Žilina, 012 07, Slovakia
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Alberton, 1449, South Africa
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Cape Town, 7925, South Africa
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Durban, 4030, South Africa
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Durban, 4126, South Africa
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Gauteng, South Africa
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Johannesburg, 1820, South Africa
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Johannesburg, 2188, South Africa
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Pretoria, 0184, South Africa
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Pretoria, 1022, South Africa
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Incheon, Gyeonggi-do, 21431, South Korea
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Suwon, Gyeonggi-do, 442-723, South Korea
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Uijeongbu-si, Gyeonggi-do, 480-717, South Korea
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Seoul, Korea, 03312, South Korea
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Seoul, Seocho Gu, 06591, South Korea
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Daejeon, 301-804, South Korea
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Incheon, 403-720, South Korea
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Seoul, 150-713, South Korea
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Sant Adria Del Besos, Barcelona, 08930, Spain
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Santa Coloma de Gramanet, Barcelona, 08921, Spain
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Barcelona, Catalonia, 08025, Spain
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Taipei, 114, Taiwan
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Taoyuan District, 33305, Taiwan
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Related Publications (5)
Tsotra F, Kappel M, Peristeris P, Bader G, Levi E, Lister N, Malhotra A, Ostwald DA. The societal impact of early intensified treatment in patients with type 2 diabetes mellitus. J Comp Eff Res. 2022 Nov;11(16):1185-1199. doi: 10.2217/cer-2022-0110. Epub 2022 Sep 28.
PMID: 36170017DERIVEDVencio S, Manosalva JP, Mathieu C, Proot P, Lozno HY, Paldanius PM. Exploring early combination strategy in Latin American patients with newly diagnosed type 2 diabetes: a sub-analysis of the VERIFY study. Diabetol Metab Syndr. 2021 Jun 15;13(1):68. doi: 10.1186/s13098-021-00686-9.
PMID: 34130731DERIVEDMatthews D, Del Prato S, Mohan V, Mathieu C, Vencio S, Chan JCN, Stumvoll M, Paldanius PM. Insights from VERIFY: Early Combination Therapy Provides Better Glycaemic Durability Than a Stepwise Approach in Newly Diagnosed Type 2 Diabetes. Diabetes Ther. 2020 Nov;11(11):2465-2476. doi: 10.1007/s13300-020-00926-7. Epub 2020 Sep 25.
PMID: 32975711DERIVEDMatthews DR, Paldanius PM, Proot P, Chiang Y, Stumvoll M, Del Prato S; VERIFY study group. Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomised, double-blind trial. Lancet. 2019 Oct 26;394(10208):1519-1529. doi: 10.1016/S0140-6736(19)32131-2. Epub 2019 Sep 18.
PMID: 31542292DERIVEDMatthews DR, Paldanius PM, Proot P, Foley JE, Stumvoll M, Del Prato S. Baseline characteristics in the VERIFY study: a randomized trial assessing the durability of glycaemic control with early vildagliptin-metformin combination in newly diagnosed Type 2 diabetes. Diabet Med. 2019 Apr;36(4):505-513. doi: 10.1111/dme.13886. Epub 2019 Feb 12.
PMID: 30576013DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2012
First Posted
February 7, 2012
Study Start
March 30, 2012
Primary Completion
April 4, 2019
Study Completion
April 4, 2019
Last Updated
September 24, 2020
Results First Posted
April 15, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com