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

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).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: vildagliptin; Drug: Metformin; Drug: Placebo of vildagliptin

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.

• Study Type: Interventional
• Enrollment (Actual): 2004
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1120AAC
    • Novartis Investigative Site
  • Cordoba, Argentina, X5000AAW
    • Novartis Investigative Site
  • Corrientes, Argentina, 3400
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1056ABJ
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1425AGC
      • Novartis Investigative Site
    • San Isidro, Buenos Aires, Argentina, 1642
      • Novartis Investigative Site
  • Capital Federal
    • Caba, Capital Federal, Argentina, C1179AAB
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• Australia
  • New South Wales
    • Brookvale, New South Wales, Australia, 2100
      • Novartis Investigative Site
    • Woy Woy, New South Wales, Australia, 2256
      • Novartis Investigative Site
  • Queensland
    • Morayfield, Queensland, Australia, 4506
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• Austria
  • Wien, Austria, A-1130
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• Brazil
  • CE
    • Fortaleza, CE, Brazil, 60170-320
      • Novartis Investigative Site
    • Fortaleza, CE, Brazil, 60430-350
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  • DF
    • Brasilia, DF, Brazil, 71625-009
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  • GO
    • Goiania, GO, Brazil, 74935-530
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  • PA
    • Belem, PA, Brazil, 66073-000
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  • PR
    • Curitiba, PR, Brazil, 80810-040
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  • RS
    • Porto Alegre, RS, Brazil, 90430 001
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  • SP
    • Mogi das Cruzes, SP, Brazil, 08780-090
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 05403 000
      • Novartis Investigative Site
    • Sao Paulo, SP, Brazil, 04023-900
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    • São Paulo, SP, Brazil, 01224-000
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    • São Paulo, SP, Brazil, 01244-030
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• Bulgaria
  • Gabrovo, Bulgaria, 5300
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  • Kazanlak, Bulgaria, 6100
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  • Plovdiv, Bulgaria, 4002
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  • Razgrad, Bulgaria
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  • Ruse, Bulgaria, 7200
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  • Smolian, Bulgaria, 4700
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  • Sofia, Bulgaria, 1431
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  • Sofia, Bulgaria, 1606
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  • Sofia, Bulgaria
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• Colombia
  • Baranquilla, Colombia
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  • Bogotá, Colombia
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  • Bolivar
    • Cartagena, Bolivar, Colombia
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  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 110221
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• Czechia
  • Brandys Nad Labem, Czechia, 250 01
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  • Praha, Czechia, 149 01
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  • Czech Republic
    • Pisek, Czech Republic, Czechia, 397 01
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    • Prague 5, Czech Republic, Czechia, 150 30
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• Dominican Republic
  • Santo Domingo, Dominican Republic
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  • Republica Dominicana
    • Santo Domingo, Republica Dominicana, Dominican Republic
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• Estonia
  • Saku, Estonia, 75501
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  • Tallinn, Estonia, 10117
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  • Tallinn, Estonia, 11315
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  • Tallinn, Estonia, 11911
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  • Tallinn, Estonia, 13415
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• Finland
  • Kerava, Finland, 04200
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  • Kouvola, Finland, 45100
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  • Tampere, Finland, 33100
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  • Suomi
    • Lahti, Suomi, Finland, 15110
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• Germany
  • Aschaffenburg, Germany, 63739
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  • Dresden, Germany, 01307
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  • Duesseldorf, Germany, 40225
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  • Essen, Germany, 45276
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  • Essen, Germany, 45329
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  • Esslingen am Neckar, Germany, 73728
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  • Fulda, Germany, 36037
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  • Gelnhausen, Germany, 63571
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  • Kamp-Lintfort, Germany, 47475
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  • Koeln, Germany, 51069
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  • Ludwigshafen, Germany, 67059
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  • Neuwied, Germany, 56564
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  • Saint Ingbert - Oberwuerzbach, Germany, 66386
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  • Wangen, Germany, 88239
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  • Hainburg
    • Hainstadt, Hainburg, Germany, 63512
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• Guatemala
  • Clinica, Guatemala, 605
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  • Guatemala City, Guatemala, 01010
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  • Guatemala City, Guatemala, 010014
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• Hong Kong
  • Hong Kong, Hong Kong
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  • HongKong, Hong Kong
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• Hungary
  • Budapest, Hungary, 1042
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  • Budapest, Hungary, 1212
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  • Csongrad, Hungary, 6640
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  • Eger, Hungary, H-3300
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  • Kalocsa, Hungary, 6300
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  • Szeged, Hungary, H 6725
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  • Veszprem, Hungary, H 8200
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  • Zala
    • Zalaegerszeg, Zala, Hungary, 8900
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• India
  • Chandigarh, India, 160 012
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  • Delhi
    • New Delhi, Delhi, India, 110076
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  • Karnataka
    • Bangalore, Karnataka, India, 560003
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    • Bangalore, Karnataka, India, 560034
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    • Bangalore, Karnataka, India, 560043
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  • Kerala
    • Kochi, Kerala, India, 682 041
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  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 452010
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  • Maharashtra
    • Pune, Maharashtra, India, 411004
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    • Pune, Maharashtra, India, 411011
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  • Rajasthan
    • Jaipur, Rajasthan, India, 302015
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    • Jaipur, Rajasthan, India, 302023
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  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 086
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  • Tamilnadu
    • Chennai, Tamilnadu, India, 600008
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• Israel
  • Heifa, Israel
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  • Jerusalem, Israel, 91192
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  • Kfar Saba, Israel, 4428164
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  • Rehovot, Israel, 7610001
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  • Sefad, Israel, 13100
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  • Tel Aviv, Israel, 6209804
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  • Tel Giborim, Holon, Israel, 58100
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• Italy
  • BS
    • Montichiari, BS, Italy, 25018
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  • CB
    • Campobasso, CB, Italy, 86100
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  • GE
    • Arenzano, GE, Italy, 16011
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  • MI
    • Milano, MI, Italy, 20132
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    • Milano, MI, Italy, 20100
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  • PV
    • Casorate Primo, PV, Italy, 27022
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  • RM
    • Roma, RM, Italy, 00161
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    • Roma, RM, Italy, 00133
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• Korea, Republic of
  • Daejeon, Korea, Republic of, 301-804
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  • Incheon, Korea, Republic of, 403-720
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  • Seoul, Korea, Republic of, 150-713
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  • Gyeonggi-do
    • Incheon, Gyeonggi-do, Korea, Republic of, 21431
      • Novartis Investigative Site
    • Suwon, Gyeonggi-do, Korea, Republic of, 442-723
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    • Uijeongbu-Si, Gyeonggi-do, Korea, Republic of, 480-717
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  • Korea
    • Seoul, Korea, Korea, Republic of, 03312
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  • Seocho Gu
    • Seoul, Seocho Gu, Korea, Republic of, 06591
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• Latvia
  • Daugavpils, Latvia, LV-5417
    • Novartis Investigative Site
  • Riga, Latvia, LV 1002
    • Novartis Investigative Site
  • Riga, Latvia, 1057
    • Novartis Investigative Site
  • LV
    • Jelgava, LV, Latvia, 3001
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    • Liepaja, LV, Latvia, 3401
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    • Ogre, LV, Latvia, 5001
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    • Riga, LV, Latvia, 1011
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    • Riga, LV, Latvia, 1002
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    • Talsi, LV, Latvia, 3201
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• Lithuania
  • Jonava, Lithuania, 55268
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  • Kaunas, Lithuania, 48259
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  • Kaunas, Lithuania, 51270
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  • Vilnius, Lithuania, LT-08661
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  • LT
    • Vilnius, LT, Lithuania
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  • LTU
    • Kaunas, LTU, Lithuania, LT 50161
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• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Novartis Investigative Site
  • Kuala Lumpur, Malaysia, 56000
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  • Kelantan
    • Kota Bahru, Kelantan, Malaysia, 16150
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• Mexico
  • Aguascalientes, Mexico, 20230
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  • Distrito Federal, Mexico, 14000
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  • Durango, Mexico, 34000
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  • Querétaro, Mexico, 76000
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  • Distrito Federal
    • Ciudad De Mexico, Distrito Federal, Mexico, 11850
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    • Mexico D.F, Distrito Federal, Mexico, 03100
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    • México, Distrito Federal, Mexico, 03800
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  • Morelos
    • Cuautla, Morelos, Mexico, 62746
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    • Cuernavaca, Morelos, Mexico, 62250
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• Norway
  • Enebakk, Norway, 1912
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  • Fetsund, Norway, 1900
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  • Honefoss, Norway, 3515
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  • Oslo, Norway, 0424
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  • Spikkestad, Norway, 3430
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• Panama
  • Panama City, Panama
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  • Panama City, Panama, 0834-01862
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• Peru
  • Arequipa, Peru
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  • La Libertad
    • Trujillo, La Libertad, Peru
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  • Lima
    • Cercado De Lima, Lima, Peru, 01
      • Novartis Investigative Site
    • Chorrillos, Lima, Peru, 09
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    • Magdalena, Lima, Peru, 17
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    • San Isidro, Lima, Peru, 27
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    • San Martin de Porres, Lima, Peru, 31
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• Philippines
  • Marikina City, Philippines, 1800
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  • Pasay City, Philippines, 1300
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  • Pasig City, Philippines, 1600
    • Novartis Investigative Site
  • San Juan City, Philippines, 1500
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  • Metro Manila
    • Marikina, Metro Manila, Philippines, 1810
      • Novartis Investigative Site
    • Quezon City, Metro Manila, Philippines, 1109
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• Poland
  • Poznan, Poland, 60-821
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  • Poznan, Poland, 61-251
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  • Poznan, Poland, 61-655
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  • Wroclaw, Poland, 50-349
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  • Zabrze, Poland, 41-800
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• Romania
  • Bucharest, Romania, 020045
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  • Bucharest, Romania, 020475
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  • Bucuresti, Romania
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  • Timisoara, Romania
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  • Bihor
    • Oradea, Bihor, Romania, 410001
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  • Jud. Bihor
    • Oradea, Jud. Bihor, Romania, 410619
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  • Jud. Prahova
    • Ploiesti, Jud. Prahova, Romania, 100097
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• Russian Federation
  • Moscow, Russian Federation, 101990
    • Novartis Investigative Site
  • 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, 194044
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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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• Slovakia
  • Banska Bystrica, Slovakia, 974 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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  • Zilina, Slovakia, 012 07
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  • Slovak Republic
    • 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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• South Africa
  • Alberton, South Africa, 1449
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  • Cape Town, South Africa, 7925
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  • Durban, South Africa, 4030
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  • Durban, South Africa, 4126
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  • Gauteng, South Africa
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  • Johannesburg, South Africa, 1820
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  • Johannesburg, South Africa, 2188
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  • Pretoria, South Africa, 0184
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  • Pretoria, South Africa, 1022
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• Spain
  • Barcelona, Spain, 08020
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  • Barcelona
    • Sant Adria Del Besos, Barcelona, Spain, 08930
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    • Santa Coloma De Gramanet, Barcelona, Spain, 08921
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  • Cataluña
    • Barcelona, Cataluña, Spain, 08025
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• Taiwan
  • Hsintien, Taiwan, 231
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  • Taichung, Taiwan, 40705
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  • Taipei, Taiwan, 114
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  • Taoyuan, Taiwan, 33305
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• Turkey
  • Adana, Turkey, 01330
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  • Antalya, Turkey, 07070
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  • Denizli, Turkey, 20070
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  • Diskapi / Ankara, Turkey, 06770
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  • Istanbul, Turkey, 34093
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  • Izmir, Turkey, 35040
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  • Izmir, Turkey, 35340
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  • Kahramanmaras, Turkey, 46100
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vilda 50mg bid + metformin; Metformin + vildagliptin	Drug: vildagliptin; One tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food.; Other Names: LAF237; Drug: Metformin; Twice daily (bid) regimen during or after meals at the same time as vildagliptin.
Experimental: Placebo + metformin; Metformin + Placebo of vildagliptin	Drug: Metformin; Twice daily (bid) regimen during or after meals at the same time as vildagliptin.; Drug: Placebo of vildagliptin; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Loss in Glycemic Control During Period 1	The rate of loss in glycemic control was estimated using the slope of HbA1c over time (years). HbA1c data collected from Week 26 up to and including the end of Period 1 visit was included in the analysis. Baseline HbA1c was the sample obtained on day 1, or the sample obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurement was missing. End of Period 1 was defined as the final post-baseline assessment obtained at any visit within Period 1 (scheduled or unscheduled), up to the last scheduled visit.	Visit 5 (Week 26) to End of Period 1
Rate of Loss in Glycemic Control in HbA1c Over Time During Period 2	The rate of loss in glycemic control was estimated using the slope of HbA1c over time (years). HbA1c data collected from 26 weeks after the start of Period 2 to the end of Period 2 were included in the analysis, for participants who started insulin therapy in Period 3 or discontinued during Period 2 due to being unable or unwilling to initiate insulin therapy in period 3. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis.	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	Rate of loss in glycemic control was estimated using the slope of FPG over time (years). FPG (fasting plasma glucose) data from Week 26 to the end of Period 1 was included in the analysis. Baseline FPG was the sample obtained on day 1, or the sample obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurement is missing. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis.	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	Rate of loss in glycemic control was estimated using the slope of FPG over time (years). FPG (fasting plasma glucose) data from 26 weeks after the start of Period 2 to then end of Period 2 was included in the analysis. Only participants who started insulin therapy in Period 3 or discontinued during Period 2 due to being unable or unwilling to initiate insulin therapy in period 3 were included. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis.	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	The rate of change of beta cell function was assessed using the slope of AUC of ISR/G over time (years) where AUC of ISR/G is defined as (Area under curve of Insulin secretion rate (derived using c-peptide))/(Area under curve of Glucose), using meal-test data from 0 to 120 minutes. Baseline AUC of ISR/G was derived based on samples obtained on day 1, or samples obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurements were missing. Three analyses were included, using data from Week 13 to the end of Period 1, end of Period 2 and end of study, respectively.	Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
Rate of Change in Insulin Sensitivity From Baseline to End of Study	The rate of change of insulin sensitivity is assessed using the slope of OGIS over time (years) where Oral glucose insulin sensitivity (OGIS) was calculated as a function of glucose and insulin, using meal-test data from 0 to 120 minutes. Baseline OGIS is derived based on samples obtained on day 1, or samples obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurements are missing. Three analyses were included, using data from Week 13 to the end of Period 1, end of Period 2 and end of study, respectively.	Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
Percentage of Participants With Adverse Events, Serious Adverse Events and Death	Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) in each treatment arm to demonstrate that LAF237 is safe for the treatment of naïve patients with type 2 diabetes mellitus through the monitoring of relevant clinical and laboratory safety parameters.	From first dose of study treatment until End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2012
• Primary Completion (Actual): April 4, 2019
• Study Completion (Actual): April 4, 2019

Study Registration Dates

• First Submitted: February 3, 2012
• First Submitted That Met QC Criteria: February 3, 2012
• First Posted (Estimate): February 7, 2012

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; Elderly Patients; Vildagliptin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Vildagliptin
• Other Study ID Numbers: CLAF237A23156; 2011-003712-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No