Clinical trial NCT01528254: VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Vildagliptin
Elderly Patients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 2004
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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 started in Period 1.
* Period 1 (vildagliptin/metformin combination versus metformin): At Visit 3, patients were randomized 1:1 to one of the following study regimens:

  * Metformin up to 1000 mg bid plus vildagliptin 50mg bid or
  * Metformin up to 1000 mg bid plus matching placebo bid

The duration of Period 1 could differ between patients depending on the time when the second of two HbA1c measurements taken at two consecutive visits after randomisation confirmed HbA1c ≥ 7.0%.

• Period 2 (vildagliptin/metformin combination versus vildagliptin add-on to metformin): In the case of two consecutive HbA1c measurements ≥7.0% from two consecutive study visits during Period 1, patients who were randomised to the placebo arm in Period 1 received vildagliptin 50 mg bid. Patients who were randomised to the active vildagliptin 50 mg bid arm in Period 1 continued to receive vildagliptin 50 mg bid. All patients continued to take their metformin dose unchanged. Period 2 remained masked to the patient and both patients and investigators remained masked to the treatment allocation in Period 1.

If, during Period 2, therapy intensification was required in accordance with the local guidelines, the patient entered Period 3. The duration of Period 2 could differ between patients. End of Period 2 was considered when insulin treatment was initiated, or alternatively when the patient was discontinued because insulin treatment was not initiated in Period 3.

• Period 3 (insulin initiation): In Period 3, patients were to be initiated on open-label insulin. The study drug regimen continued unchanged and remained masked to the patient in Period 3 and both patients and investigators remained masked to the treatment allocation in Period 1.

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.

Primary outcomes:
measure: Time to Initial Treatment Failure
timeFrame: Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
Secondary outcomes:
measure: Rate of Loss in Glycemic Control During Period 1
timeFrame: Visit 5 (Week 26) to End of Period 1
measure: Rate of Loss in Glycemic Control in HbA1c Over Time During Period 2
timeFrame: From 26 weeks after start of Period 2 to end of Period 2
measure: Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) During Period 1
timeFrame: Visit 5 (Week 26) to End of Period 1
measure: Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) Over Time During Period 2
timeFrame: From 26 weeks after start of Period 2 to end of Period 2
measure: Rate of Loss of Beta Cell Function From Baseline to End of Study
timeFrame: Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
measure: Rate of Change in Insulin Sensitivity From Baseline to End of Study
timeFrame: Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
measure: Percentage of Participants With Adverse Events, Serious Adverse Events and Death
timeFrame: From first dose of study treatment until End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: San Isidro
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Corrientes
country: Argentina
facility: Novartis Investigative Site
city: Brookvale
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Woy Woy
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Morayfield
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Fortaleza
country: Brazil
facility: Novartis Investigative Site
state: CE
city: Fortaleza
country: Brazil
facility: Novartis Investigative Site
state: CE
city: Brasilia
country: Brazil
facility: Novartis Investigative Site
state: DF
city: Goiania
country: Brazil
facility: Novartis Investigative Site
state: GO
city: Belem
country: Brazil
facility: Novartis Investigative Site
state: PA
city: Curitiba
country: Brazil
facility: Novartis Investigative Site
state: PR
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Mogi das Cruzes
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Gabrovo
country: Bulgaria
facility: Novartis Investigative Site
city: Kazanlak
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Razgrad
country: Bulgaria
facility: Novartis Investigative Site
city: Ruse
country: Bulgaria
facility: Novartis Investigative Site
city: Smolian
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Cartagena
country: Colombia
facility: Novartis Investigative Site
state: Bolivar
city: Bogota
country: Colombia
facility: Novartis Investigative Site
state: Cundinamarca
city: Baranquilla
country: Colombia
facility: Novartis Investigative Site
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
city: Pisek
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Prague 5
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Brandys Nad Labem
country: Czechia
facility: Novartis Investigative Site
city: Praha
country: Czechia
facility: Novartis Investigative Site
city: Santo Domingo
country: Dominican Republic
facility: Novartis Investigative Site
state: Republica Dominicana
city: Santo Domingo
country: Dominican Republic
facility: Novartis Investigative Site
city: Saku
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Lahti
country: Finland
facility: Novartis Investigative Site
state: Suomi
city: Kerava
country: Finland
facility: Novartis Investigative Site
city: Kouvola
country: Finland
facility: Novartis Investigative Site
city: Tampere
country: Finland
facility: Novartis Investigative Site
city: Hainstadt
country: Germany
facility: Novartis Investigative Site
state: Hainburg
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Esslingen am Neckar
country: Germany
facility: Novartis Investigative Site
city: Fulda
country: Germany
facility: Novartis Investigative Site
city: Gelnhausen
country: Germany
facility: Novartis Investigative Site
city: Kamp-Lintfort
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
country: Germany
facility: Novartis Investigative Site
city: Neuwied
country: Germany
facility: Novartis Investigative Site
city: Saint Ingbert - Oberwuerzbach
country: Germany
facility: Novartis Investigative Site
city: Wangen
country: Germany
facility: Novartis Investigative Site
city: Clinica
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: HongKong
country: Hong Kong
facility: Novartis Investigative Site
city: Zalaegerszeg
country: Hungary
facility: Novartis Investigative Site
state: Zala
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Csongrad
country: Hungary
facility: Novartis Investigative Site
city: Eger
country: Hungary
facility: Novartis Investigative Site
city: Kalocsa
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Veszprem
country: Hungary
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Kochi
country: India
facility: Novartis Investigative Site
state: Kerala
city: Indore
country: India
facility: Novartis Investigative Site
state: Madhya Pradesh
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Jaipur
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Jaipur
country: India
facility: Novartis Investigative Site
state: Rajasthan
city: Chennai
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Chennai
country: India
facility: Novartis Investigative Site
state: Tamilnadu
city: Chandigarh
country: India
facility: Novartis Investigative Site
city: Heifa
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Kfar Saba
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Sefad
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Tel Giborim, Holon
country: Israel
facility: Novartis Investigative Site
city: Montichiari
country: Italy
facility: Novartis Investigative Site
state: BS
city: Campobasso
country: Italy
facility: Novartis Investigative Site
state: CB
city: Arenzano
country: Italy
facility: Novartis Investigative Site
state: GE
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Casorate Primo
country: Italy
facility: Novartis Investigative Site
state: PV
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Uijeongbu-Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seocho Gu
city: Daejeon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Jelgava
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Liepaja
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Ogre
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Talsi
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
state: LT
city: Jonava
country: Lithuania
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Kota Bahru
country: Malaysia
facility: Novartis Investigative Site
state: Kelantan
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Ciudad De Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Mexico D.F
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: México
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Cuautla
country: Mexico
facility: Novartis Investigative Site
state: Morelos
city: Cuernavaca
country: Mexico
facility: Novartis Investigative Site
state: Morelos
city: Aguascalientes
country: Mexico
facility: Novartis Investigative Site
city: Distrito Federal
country: Mexico
facility: Novartis Investigative Site
city: Durango
country: Mexico
facility: Novartis Investigative Site
city: Querétaro
country: Mexico
facility: Novartis Investigative Site
city: Enebakk
country: Norway
facility: Novartis Investigative Site
city: Fetsund
country: Norway
facility: Novartis Investigative Site
city: Honefoss
country: Norway
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Spikkestad
country: Norway
facility: Novartis Investigative Site
city: Panama City
country: Panama
facility: Novartis Investigative Site
city: Panama City
country: Panama
facility: Novartis Investigative Site
city: Trujillo
country: Peru
facility: Novartis Investigative Site
state: La Libertad
city: Cercado De Lima
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Chorrillos
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Magdalena
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Isidro
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Martin de Porres
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Arequipa
country: Peru
facility: Novartis Investigative Site
city: Marikina
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: Marikina City
country: Philippines
facility: Novartis Investigative Site
city: Pasay City
country: Philippines
facility: Novartis Investigative Site
city: Pasig City
country: Philippines
facility: Novartis Investigative Site
city: San Juan City
country: Philippines
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Zabrze
country: Poland
facility: Novartis Investigative Site
city: Oradea
country: Romania
facility: Novartis Investigative Site
state: Bihor
city: Oradea
country: Romania
facility: Novartis Investigative Site
state: Jud. Bihor
city: Ploiesti
country: Romania
facility: Novartis Investigative Site
state: Jud. Prahova
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Timisoara
country: Romania
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: N.Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Penza
country: Russian Federation
facility: Novartis Investigative Site
city: Petrozavodsk
country: Russian Federation
facility: Novartis Investigative Site
city: Ryazan
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
country: Russian Federation
facility: Novartis Investigative Site
city: St-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St.- Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Lucenec
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Namestovo
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Roznava
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Sala
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Trebisov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Zilina
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Levice
country: Slovakia
facility: Novartis Investigative Site
city: Nové Zámky
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Sabinov
country: Slovakia
facility: Novartis Investigative Site
city: Sered
country: Slovakia
facility: Novartis Investigative Site
city: Sturovo
country: Slovakia
facility: Novartis Investigative Site
city: Zilina
country: Slovakia
facility: Novartis Investigative Site
city: Alberton
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Durban
country: South Africa
facility: Novartis Investigative Site
city: Durban
country: South Africa
facility: Novartis Investigative Site
city: Gauteng
country: South Africa
facility: Novartis Investigative Site
city: Johannesburg
country: South Africa
facility: Novartis Investigative Site
city: Johannesburg
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Sant Adria Del Besos
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Santa Coloma De Gramanet
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Hsintien
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taoyuan
country: Taiwan
facility: Novartis Investigative Site
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Antalya
country: Turkey
facility: Novartis Investigative Site
city: Denizli
country: Turkey
facility: Novartis Investigative Site
city: Diskapi / Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kahramanmaras
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Vencio 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.
citation: Matthews 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.
citation: Matthews 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.
citation: Matthews 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.