VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus

Overview[ - collapse ][ - ]

Purpose The purpose of this study is 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 T2DM.
ConditionType 2 Diabetes Mellitus
InterventionDrug: Placebo to vildagliptin
Drug: vildagliptin
Drug: Metformin
PhasePhase 4
SponsorNovartis Pharmaceuticals
Responsible PartyNovartis
ClinicalTrials.gov IdentifierNCT01528254
First ReceivedFebruary 3, 2012
Last UpdatedMay 21, 2013
Last verifiedMay 2013

Tracking Information[ + expand ][ + ]

First Received DateFebruary 3, 2012
Last Updated DateMay 21, 2013
Start DateJanuary 2012
Estimated Primary Completion DateFebruary 2019
Current Primary Outcome Measures
  • Rate of loss in glycemic control over time [Time Frame: Week 26] [Designated as safety issue: No]
  • Time to initial treatment failure [Time Frame: 5 years] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Rate of loss in glycemic control in fasting plasma glucose [Time Frame: Up to 5 years] [Designated as safety issue: No]
  • Rate of loss in glycemic control in fasting plasma glucose (FPG) during period 2 [Time Frame: up to 5 years] [Designated as safety issue: No]
  • Rate of loss of beta cell function from baseline to end of study ( 5 years) [Time Frame: From baseline to end of study (5 years)] [Designated as safety issue: No]
  • Number patients with adverse events, death and serious adverse events [Time Frame: 5 years] [Designated as safety issue: Yes]
  • Rate of loss in glycemic control in over time [Time Frame: up to 5 years] [Designated as safety issue: No]
  • Rate of change in insulin sensitivity from baseline to end of study (5 years) [Time Frame: From baseline to end of study (5 years)] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleVERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
Official TitleA 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
Brief Summary
The purpose of this study is 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 T2DM.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: Placebo to vildagliptin
Drug: vildagliptin
Patients will be instructed to take one tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food.
Other Names:
LAF237Drug: Metformin
Metformin should be taken in a twice daily (bid) regimen during or after meals at the same time as vildagliptin.
Study Arm (s)
  • Active Comparator: Metformin + vildagliptin
  • Experimental: Metformin + Placebo of vildagliptin

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment2000
Estimated Completion DateFebruary 2019
Estimated Primary Completion DateFebruary 2019
Eligibility Criteria
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

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

Other protocol-defined inclusion/exclusion criteria may apply
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Novartis Pharmaceuticals
+41613241111
Location CountriesArgentina, Australia, Austria, Brazil, Bulgaria, Canada, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Estonia, Finland, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Norway, Panama, Peru, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Taiwan, Turkey

Administrative Information[ + expand ][ + ]

NCT Number NCT01528254
Other Study ID NumbersCLAF237A23156
Has Data Monitoring CommitteeNot Provided
Information Provided ByNovartis
Study SponsorNovartis Pharmaceuticals
CollaboratorsNot Provided
Investigators Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Verification DateMay 2013

Locations[ + expand ][ + ]

Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000AII
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Buenos Aires, Argentina, C1425AGC
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Buenos Aires, Argentina, C1056ABJ
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Buenos Aires, Argentina, B1642DCD
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Buenos aires, Argentina, C1120AAC
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Capital Federal, Argentina, C1179AAB
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Cordoba, Argentina, X5000AAW
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Corrientes, Argentina, W3410AVV
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Brookvale, New South Wales, Australia, 2100
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Manly, New South Wales, Australia, 2095
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Woy Woy, New South Wales, Australia, 2256
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Mermaid Beach, Queensland, Australia, 4218
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Morayfield, Queensland, Australia, 4506
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Linz, Austria, 4021
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Salzburg, Austria, A-5020
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Wien, Austria, A-1130
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Fortaleza, CE, Brazil, 60430-140
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Curitiba, PR, Brazil, 80810-040
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Mogi das Cruzes, SP, Brazil, 08780-090
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Gabrovo, Bulgaria, 5300
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Kazanlak, Bulgaria, 6100
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Plovdiv, Bulgaria, 4002
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Ruse, Bulgaria, 7200
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Sofia, Bulgaria
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Sofia, Bulgaria, 1606
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Sofia, Bulgaria, 1606
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Sofia, Bulgaria, 1431
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Calgary, Alberta, Canada, T2H 2G4
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Spruce Grove, Alberta, Canada, T7X 2V2
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Winnipeg, Manitoba, Canada, R2V 4W3
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Winnipeg, Manitoba, Canada, R3E 3P4
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Moncton, New Brunswick, Canada, E1G 1A7
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St. John's, Newfoundland and Labrador, Canada, A1A 3R5
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Halifax, Nova Scotia, Canada, B3K 2M5
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Brampton, Ontario, Canada, L6S 0C9
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Toronto, Ontario, Canada, M9V 4B4
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Toronto, Ontario, Canada, M4G 3E8
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Drummondville, Quebec, Canada, J2B 7T1
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Gatineau, Quebec, Canada, J8Y 6S8
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Mirabel, Quebec, Canada, J7J 2K8
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Sherbrooke, Quebec, Canada, J1G 5K2
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St-Romuald, Quebec, Canada, G6W 5M6
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Ste-Foy, Quebec, Canada, G1W 4R4
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Victoriaville, Quebec, Canada, G6P 6P6
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Quebec, Canada, G3K 2P8
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Cartagena, Bolivar, Colombia
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Bogota, Cundinamarca, Colombia
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Baranquilla, Colombia
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Bogotá, Colombia
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Bogotá, Colombia
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Cartago, Costa Rica, 75-100
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San Pedro, Costa Rica, 1406-1200
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Brandys Nad Labem, Czech Republic, 250 01
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Ostrava, Czech Republic, 709 00
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Pisek, Czech Republic, 397 01
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Tallinn, Estonia, 13415
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Tallinn, Estonia, 10117
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Tallinn, Estonia, 11911
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Tallinn, Estonia, 13419
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Lahti, Suomi, Finland, 15110
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Helsinki, Finland, 00930
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Kerava, Finland, 04200
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Kokkola, Finland, 67100
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Kouvola, Finland, 45100
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Kuopio, Finland, 70211
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Oulu, Finland, 90100
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Seinajoki, Finland, FIN-60220
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Guatemala City, Guatemala, 010014
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Firenze, FI, Italy, 50134
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Seoul, Korea, Republic of, 150-713
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Jelgava, LV, Latvia, 3001
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Riga, LV, Latvia, 1011
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Riga, LV, Latvia, 1002
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Daugavplis, Latvia, LV-5417
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Valmiera, Latvia, 4201
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Jonava, Lithuania, 55268
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Kaunas, Lithuania, 48259
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Kaunas, Lithuania, 51270
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Kaunas, Lithuania, 50009
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Vilnius, Lithuania, LT-10207
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Vilnius, Lithuania, LT-08661
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Kota Bahru, Kelantan, Malaysia, 16150
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Kuala Lumpur, Malaysia, 59100
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Kuala Lumpur, Malaysia, 56000
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Ciudad De Mexico, Distrito Federal, Mexico, 11850
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México, Distrito Federal, Mexico, 14000
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México, Distrito Federal, Mexico, 03800
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Pachuca, Hidalgo, Mexico, 42086
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Cuautla, Morelos, Mexico, 62746
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Fetsund, Norway, 1900
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Hønefoss, Norway, 3515
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Oslo, Norway, 0424
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Skedsmokorset, Norway, 2020
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Panama City, Panamá, Panama
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Panama City, Panamá, Panama, 0834-01862
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Magdalena, Lima, Peru, 17
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San Isidro, Lima, Peru, 27
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Santiago de Surco, Lima, Peru, 33
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Marikina, Metro Manila, Philippines, 1810
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Quezon City, Metro Manila, Philippines, 1109
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Kutno, Poland, 99-300
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Poznan, Poland, 60-823
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Poznan, Poland, 61-655
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Poznan, Poland, 61-251
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Oradea, Jud. Bihor, Romania, 410619
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Oradea, Jud. Bihor, Romania, 410032
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Bucharest, Romania, 020045
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Timisoara, Romania
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Krasnodar, Russian Federation, 350063
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Moscow, Russian Federation, 101953
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N.Novgorod, Russian Federation, 603126
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Penza, Russian Federation, 440026
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Petrozavodsk, Russian Federation, 185019
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Ryazan, Russian Federation, 390026
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Saint-Petersburg, Russian Federation, 198260
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Saint-Petersburg, Russian Federation, 198013
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Saratov, Russian Federation, 410012
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Smolensk, Russian Federation, 214019
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St-Petersburg, Russian Federation, 194358
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St.- Petersburg, Russian Federation, 199034
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Bratislava, Slovak Republic, Slovakia, 85101
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Kosice, Slovak Republic, Slovakia, 04001
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Lucenec, Slovak Republic, Slovakia, 98401
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Namestovo, Slovak Republic, Slovakia, 02901
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Roznava, Slovak Republic, Slovakia, 04801
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Sala, Slovak Republic, Slovakia, 92701
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Trebisov, Slovak Republic, Slovakia, 075 01
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Zilina, Slovak Republic, Slovakia, 010 01
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Banska Bystrica, Slovakia, 974 01
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Kosice, Slovakia, 040 01
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Kosice, Slovakia, 040 01
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Kosice, Slovakia, 040 22
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Levice, Slovakia, 934 01
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Nové Zámky, Slovakia, 940 01
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Presov, Slovakia, 080 01
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Sabinov, Slovakia, 08301
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Sered, Slovakia, 92601
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Sturovo, Slovakia, 94301
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Trnava, Slovakia, 917 01
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Zilina, Slovakia, 012 07
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Alberton, South Africa, 1449
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Cape Town, South Africa, 7925
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Cape Town, South Africa
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Durban, South Africa, 4126
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Novartis Investigative Site
Durban, South Africa, 4030
Recruiting
Novartis Investigative Site
Gauteng, South Africa
Recruiting
Novartis Investigative Site
Johannesburg, South Africa, 1820
Recruiting
Novartis Investigative Site
Kempton Park, South Africa, 1620
Withdrawn
Novartis Investigative Site
Pretoria, South Africa, 0184
Not yet recruiting
Novartis Investigative Site
Pretoria, South Africa, 1022
Not yet recruiting
Novartis Investigative Site
Pretoria, South Africa, 0002
Not yet recruiting
Novartis Investigative Site
Yungkang, Tainan, Taiwan, 710
Withdrawn
Novartis Investigative Site
Changhua, Taiwan, 500
Withdrawn
Novartis Investigative Site
Chia-Yi, Taiwan, 600
Not yet recruiting
Novartis Investigative Site
Hsintien, Taiwan, 231
Recruiting
Novartis Investigative Site
Lin-Ko, Taiwan, 33305
Recruiting
Novartis Investigative Site
Taichung, Taiwan, 40705
Recruiting
Novartis Investigative Site
Taipei, Taiwan, 114
Recruiting
Novartis Investigative Site
Adana, Turkey, 01330
Recruiting
Novartis Investigative Site
Antalya, Turkey, 07070
Not yet recruiting
Novartis Investigative Site
Diskapi / Ankara, Turkey, 06770
Recruiting
Novartis Investigative Site
Istanbul, Turkey, 34093
Not yet recruiting
Novartis Investigative Site
Istanbul, Turkey, 34304
Not yet recruiting
Novartis Investigative Site
Istanbul, Turkey, 34093
Recruiting
Novartis Investigative Site
Izmir, Turkey, 35040
Recruiting
Novartis Investigative Site
Izmir, Turkey, 35340
Recruiting
Novartis Investigative Site
Kahramanmaras, Turkey, 46100
Recruiting
Novartis Investigative Site
Karsiyaka / Izmir, Turkey, 35590
Not yet recruiting
Novartis Investigative Site
Kinikli / Denizli, Turkey, 20070
Recruiting
Novartis Investigative Site
Kocaeli, Turkey, 41380
Not yet recruiting
Novartis Investigative Site
Manisa, Turkey, 45040
Not yet recruiting
Novartis Investigative Site
Yenisehir / Izmir, Turkey
Not yet recruiting