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Type 2 Diabetes MellitusPhase 4NCT01528254

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

A Phase 4 study testing vildagliptin and Metformin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 227 sites in 34 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
vildagliptin and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,004 participants
Where
227 sitesin 34 countries
Study dates
30 Mar 2012to 4 Apr 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

227 sites in 34 countries.

227 sites in 34 countries

Slovakia18 sites

  • Novartis Investigative Site

    Banská Bystrica, 974 01

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 85101

  • Novartis Investigative Site

    Košice, Slovak Republic, 04001

  • Novartis Investigative Site

    Košice, 040 01

  • Novartis Investigative Site

    Košice, 040 22

  • Novartis Investigative Site

    Levice, 934 01

  • Novartis Investigative Site

    Lučenec, Slovak Republic, 98401

  • Novartis Investigative Site

    Námestovo, Slovak Republic, 02901

  • Novartis Investigative Site

    Nové Zámky, 940 01

  • Novartis Investigative Site

    Prešov, 080 01

  • Novartis Investigative Site

    Rožňava, Slovak Republic, 04801

  • Novartis Investigative Site

    Sabinov, 08301

  • Novartis Investigative Site

    Šaľa, Slovak Republic, 92701

  • Novartis Investigative Site

    Sereď, 92601

  • Novartis Investigative Site

    Štúrovo, 94301

  • Novartis Investigative Site

    Trebišov, Slovak Republic, 075 01

  • Novartis Investigative Site

    Žilina, Slovak Republic, 010 01

  • Novartis Investigative Site

    Žilina, 012 07

Other trials in Slovakia

Germany15 sites

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Cologne, 51069

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Düsseldorf, 40225

  • Novartis Investigative Site

    Essen, 45276

  • Novartis Investigative Site

    Essen, 45329

  • Novartis Investigative Site

    Esslingen am Neckar, 73728

  • Novartis Investigative Site

    Fulda, 36037

  • Novartis Investigative Site

    Gelnhausen, 63571

  • Novartis Investigative Site

    Hainstadt, Hainburg, 63512

  • Novartis Investigative Site

    Kamp-Lintfort, 47475

  • Novartis Investigative Site

    Ludwigshafen, 67059

  • Novartis Investigative Site

    Neuwied, 56564

  • Novartis Investigative Site

    Saint Ingbert - Oberwuerzbach, 66386

  • Novartis Investigative Site

    Wangen, 88239

Other trials in Germany

India13 sites

  • Novartis Investigative Site

    Bangalore, Karnataka, 560003

  • Novartis Investigative Site

    Bangalore, Karnataka, 560034

  • Novartis Investigative Site

    Bangalore, Karnataka, 560043

  • Novartis Investigative Site

    Chandigarh, 160 012

  • Novartis Investigative Site

    Chennai, Tamil Nadu, 600 086

  • Novartis Investigative Site

    Chennai, Tamil Nadu, 600008

  • Novartis Investigative Site

    Indore, Madhya Pradesh, 452010

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302015

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302023

  • Novartis Investigative Site

    Kochi, Kerala, 682 041

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110076

  • Novartis Investigative Site

    Pune, Maharashtra, 411004

  • Novartis Investigative Site

    Pune, Maharashtra, 411011

Other trials in India

Brazil12 sites

  • Novartis Investigative Site

    Belém, Pará, 66073-000

  • Novartis Investigative Site

    Brasília, Federal District, 71625-009

  • Novartis Investigative Site

    Curitiba, Paraná, 80810-040

  • Novartis Investigative Site

    Fortaleza, Ceará, 60170-320

  • Novartis Investigative Site

    Fortaleza, Ceará, 60430-350

  • Novartis Investigative Site

    Goiânia, Goiás, 74935-530

  • Novartis Investigative Site

    Mogi das Cruzes, São Paulo, 08780-090

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90430 001

  • Novartis Investigative Site

    São Paulo, São Paulo, 01224-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 01244-030

  • Novartis Investigative Site

    São Paulo, São Paulo, 04023-900

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403 000

Other trials in Brazil

Russia11 sites

  • Novartis Investigative Site

    Moscow, 101990

  • Novartis Investigative Site

    N.Novgorod, 603126

  • Novartis Investigative Site

    Penza, 440026

  • Novartis Investigative Site

    Petrozavodsk, 185019

  • Novartis Investigative Site

    Ryazan, 390026

  • Novartis Investigative Site

    Saint Petersburg, 194044

  • Novartis Investigative Site

    Saint Petersburg, 194358

  • Novartis Investigative Site

    Saint Petersburg, 198260

  • Novartis Investigative Site

    Saint Petersburg, 199034

  • Novartis Investigative Site

    Saratov, 410012

  • Novartis Investigative Site

    Smolensk, 214019

Other trials in Russia

Bulgaria9 sites

  • Novartis Investigative Site

    Gabrovo, 5300

  • Novartis Investigative Site

    Kazanlak, 6100

  • Novartis Investigative Site

    Plovdiv, 4002

  • Novartis Investigative Site

    Razgrad

  • Novartis Investigative Site

    Rousse, 7200

  • Novartis Investigative Site

    Smolyan, Bulgaria, 4700

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Sofia, 1606

  • Novartis Investigative Site

    Sofia

Other trials in Bulgaria

Latvia9 sites

  • Novartis Investigative Site

    Daugavpils, LV-5417

  • Novartis Investigative Site

    Jelgava, LV, 3001

  • Novartis Investigative Site

    Liepāja, LV, 3401

  • Novartis Investigative Site

    Ogre, LV, 5001

  • Novartis Investigative Site

    Riga, LV, 1002

  • Novartis Investigative Site

    Riga, LV, 1011

  • Novartis Investigative Site

    Riga, 1057

  • Novartis Investigative Site

    Riga, LV 1002

  • Novartis Investigative Site

    Talsi, LV, 3201

Other trials in Latvia

Mexico9 sites

  • Novartis Investigative Site

    Aguascalientes, 20230

  • Novartis Investigative Site

    Cuautla, Morelos, 62746

  • Novartis Investigative Site

    Cuernavaca, Morelos, 62250

  • Novartis Investigative Site

    Distrito Federal, 14000

  • Novartis Investigative Site

    Durango, 34000

  • Novartis Investigative Site

    Mexico City, Mexico City, 03100

  • Novartis Investigative Site

    Mexico City, Mexico City, 03800

  • Novartis Investigative Site

    Mexico City, Mexico City, 11850

  • Novartis Investigative Site

    Querétaro, 76000

Other trials in Mexico

South Africa9 sites

  • Novartis Investigative Site

    Alberton, 1449

  • Novartis Investigative Site

    Cape Town, 7925

  • Novartis Investigative Site

    Durban, 4030

  • Novartis Investigative Site

    Durban, 4126

  • Novartis Investigative Site

    Gauteng

  • Novartis Investigative Site

    Johannesburg, 1820

  • Novartis Investigative Site

    Johannesburg, 2188

  • Novartis Investigative Site

    Pretoria, 0184

  • Novartis Investigative Site

    Pretoria, 1022

Other trials in South Africa

Hungary8 sites

  • Novartis Investigative Site

    Budapest, 1042

  • Novartis Investigative Site

    Budapest, 1212

  • Novartis Investigative Site

    Csongrád, 6640

  • Novartis Investigative Site

    Eger, H-3300

  • Novartis Investigative Site

    Kalocsa, 6300

  • Novartis Investigative Site

    Szeged, H 6725

  • Novartis Investigative Site

    Veszprém, H 8200

  • Novartis Investigative Site

    Zalaegerszeg, Zala County, 8900

Other trials in Hungary

Italy8 sites

  • Novartis Investigative Site

    Arenzano, GE, 16011

  • Novartis Investigative Site

    Campobasso, CB, 86100

  • Novartis Investigative Site

    Casorate Primo, PV, 27022

  • Novartis Investigative Site

    Milan, MI, 20100

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Montichiari, BS, 25018

  • Novartis Investigative Site

    Roma, RM, 00133

  • Novartis Investigative Site

    Roma, RM, 00161

Other trials in Italy

South Korea8 sites

  • Novartis Investigative Site

    Daejeon, 301-804

  • Novartis Investigative Site

    Incheon, Gyeonggi-do, 21431

  • Novartis Investigative Site

    Incheon, 403-720

  • Novartis Investigative Site

    Seoul, Korea, 03312

  • Novartis Investigative Site

    Seoul, Seocho Gu, 06591

  • Novartis Investigative Site

    Seoul, 150-713

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 442-723

  • Novartis Investigative Site

    Uijeongbu-si, Gyeonggi-do, 480-717

Other trials in South Korea

Turkey (Türkiye)8 sites

  • Novartis Investigative Site

    Adana, 01330

  • Novartis Investigative Site

    Antalya, 07070

  • Novartis Investigative Site

    Denizli, 20070

  • Novartis Investigative Site

    Diskapi / Ankara, Turkey, 06770

  • Novartis Investigative Site

    Istanbul, 34093

  • Novartis Investigative Site

    Izmir, 35040

  • Novartis Investigative Site

    Izmir, 35340

  • Novartis Investigative Site

    Kahramanmaraş, 46100

Other trials in Turkey (Türkiye)

Argentina7 sites

  • Novartis Investigative Site

    Buenos Aires, C1120AAC

  • Novartis Investigative Site

    CABA, Buenos Aires, C1056ABJ

  • Novartis Investigative Site

    CABA, Buenos Aires, C1425AGC

  • Novartis Investigative Site

    CABA, Buenos Aires F.D., C1179AAB

  • Novartis Investigative Site

    Córdoba, X5000AAW

  • Novartis Investigative Site

    Corrientes, 3400

  • Novartis Investigative Site

    San Isidro, Buenos Aires, 1642

Other trials in Argentina

Israel7 sites

  • Novartis Investigative Site

    Haifa, Israel

  • Novartis Investigative Site

    Jerusalem, 91192

  • Novartis Investigative Site

    Kfar Saba, 4428164

  • Novartis Investigative Site

    Rehovot, 7610001

  • Novartis Investigative Site

    Sefad, 13100

  • Novartis Investigative Site

    Tel Aviv, 6209804

  • Novartis Investigative Site

    Tel Giborim, Holon, 58100

Other trials in Israel

Peru7 sites

  • Novartis Investigative Site

    Arequipa

  • Novartis Investigative Site

    Chorrillos, Lima region, 09

  • Novartis Investigative Site

    Lima Cercado, Lima region, 01

  • Novartis Investigative Site

    Magdalena, Lima region, 17

  • Novartis Investigative Site

    San Isidro, Lima region, 27

  • Novartis Investigative Site

    San Martín de Porres, Lima region, 31

  • Novartis Investigative Site

    Trujillo, La Libertad

Other trials in Peru

Romania7 sites

  • Novartis Investigative Site

    Bucharest, 020045

  • Novartis Investigative Site

    Bucharest, 020475

  • Novartis Investigative Site

    Bucharest

  • Novartis Investigative Site

    Oradea, Bihor County, 410001

  • Novartis Investigative Site

    Oradea, Jud. Bihor, 410619

  • Novartis Investigative Site

    Ploieşti, Jud. Prahova, 100097

  • Novartis Investigative Site

    Timișoara

Other trials in Romania

Lithuania6 sites

  • Novartis Investigative Site

    Jonava, 55268

  • Novartis Investigative Site

    Kaunas, LTU, LT 50161

  • Novartis Investigative Site

    Kaunas, 48259

  • Novartis Investigative Site

    Kaunas, 51270

  • Novartis Investigative Site

    Vilnius, LT

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Philippines6 sites

  • Novartis Investigative Site

    Marikina City, National Capital Region, 1810

  • Novartis Investigative Site

    Marikina City, 1800

  • Novartis Investigative Site

    Pasay, Philippines, 1300

  • Novartis Investigative Site

    Pasig, 1600

  • Novartis Investigative Site

    Quezon City, National Capital Region, 1109

  • Novartis Investigative Site

    San Juan City, 1500

Other trials in Philippines

Estonia5 sites

  • Novartis Investigative Site

    Saku, 75501

  • Novartis Investigative Site

    Tallinn, 10117

  • Novartis Investigative Site

    Tallinn, 11315

  • Novartis Investigative Site

    Tallinn, 11911

  • Novartis Investigative Site

    Tallinn, 13415

Other trials in Estonia

Norway5 sites

  • Novartis Investigative Site

    Enebakk, 1912

  • Novartis Investigative Site

    Fetsund, 1900

  • Novartis Investigative Site

    Hønefoss, 3515

  • Novartis Investigative Site

    Oslo, 0424

  • Novartis Investigative Site

    Spikkestad, 3430

Other trials in Norway

Poland5 sites

  • Novartis Investigative Site

    Poznan, 60-821

  • Novartis Investigative Site

    Poznan, 61-251

  • Novartis Investigative Site

    Poznan, 61-655

  • Novartis Investigative Site

    Wroclaw, 50-349

  • Novartis Investigative Site

    Zabrze, 41-800

Other trials in Poland

Colombia4 sites

  • Novartis Investigative Site

    Baranquilla

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221

  • Novartis Investigative Site

    Bogotá

  • Novartis Investigative Site

    Cartagena, Departamento de Bolívar

Other trials in Colombia

Czechia4 sites

  • Novartis Investigative Site

    Brandýs nad Labem, 250 01

  • Novartis Investigative Site

    Písek, Czech Republic, 397 01

  • Novartis Investigative Site

    Prague, Czech Republic, 150 30

  • Novartis Investigative Site

    Prague, 149 01

Other trials in Czechia

Finland4 sites

  • Novartis Investigative Site

    Kerava, 04200

  • Novartis Investigative Site

    Kouvola, 45100

  • Novartis Investigative Site

    Lahti, Suomi, 15110

  • Novartis Investigative Site

    Tampere, 33100

Other trials in Finland

Spain4 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08025

  • Novartis Investigative Site

    Barcelona, 08020

  • Novartis Investigative Site

    Sant Adria Del Besos, Barcelona, 08930

  • Novartis Investigative Site

    Santa Coloma de Gramanet, Barcelona, 08921

Other trials in Spain

Taiwan4 sites

  • Novartis Investigative Site

    Taichung, 40705

  • Novartis Investigative Site

    Taipei, 114

  • Novartis Investigative Site

    Taoyuan, 33305

  • Novartis Investigative Site

    Xindian District, 231

Other trials in Taiwan

Australia3 sites

  • Novartis Investigative Site

    Brookvale, New South Wales, 2100

  • Novartis Investigative Site

    Morayfield, Queensland, 4506

  • Novartis Investigative Site

    Woy Woy, New South Wales, 2256

Other trials in Australia

Guatemala3 sites

  • Novartis Investigative Site

    Clinica, Departamento de Guatemala, 605

  • Novartis Investigative Site

    Guatemala City, 010014

  • Novartis Investigative Site

    Guatemala City, 01010

Other trials in Guatemala

Malaysia3 sites

  • Novartis Investigative Site

    Kota Bharu, Kelantan, 16150

  • Novartis Investigative Site

    Kuala Lumpur, 56000

  • Novartis Investigative Site

    Kuala Lumpur, 59100

Other trials in Malaysia

Dominican Republic2 sites

  • Novartis Investigative Site

    Santo Domingo, Republica Dominicana

  • Novartis Investigative Site

    Santo Domingo

Other trials in Dominican Republic

Panama2 sites

  • Novartis Investigative Site

    Panama City, 0834-01862

  • Novartis Investigative Site

    Panama City

Other trials in Panama

Austria1 site

  • Novartis Investigative Site

    Vienna, A-1130

Other trials in Austria

Hong Kong1 site

  • Novartis Investigative Site

    Hong Kong

Other trials in Hong Kong

About this study

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

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).

Read the 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.
Being tested
Placebo of vildagliptin, vildagliptin, Metformin
Keywords
Type 2 Diabetes Mellitus, Vildagliptin, Elderly Patients
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo of vildagliptinDrug

    Also called Placebo

  • vildagliptinDrug

    Also called LAF237

    One tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food.

  • MetforminDrug

    Twice daily (bid) regimen during or after meals at the same time as vildagliptin.

Study groups in NCT01528254
Study groupRoleWhat they receive
Vilda 50mg bid + metforminActive comparatorMetformin + vildagliptin
Receives: Drug: vildagliptin; Drug: Metformin
Placebo + metforminExperimentalMetformin + Placebo of vildagliptin
Receives: Drug: Placebo of vildagliptin; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)

Secondary outcomes (7)

  1. 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.

    Measured: Visit 5 (Week 26) to End of Period 1

  2. 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.

    Measured: From 26 weeks after start of Period 2 to end of Period 2

  3. 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.

    Measured: Visit 5 (Week 26) to End of Period 1

  4. 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.

    Measured: From 26 weeks after start of Period 2 to end of Period 2

  5. 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.

    Measured: Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)

  6. 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.

    Measured: Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)

  7. 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.

    Measured: From first dose of study treatment until End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2012 (estimated)
  2. Study start30 Mar 2012
  3. Primary completion4 Apr 2019
  4. Study completion4 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,004 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01528254
Sponsor's protocol ID
CLAF237A23156
Other IDs
2011-003712-23
Status last verified
Sep 2020
First submitted
3 Feb 2012
Last updated
24 Sep 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

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.

    PubMed 36170017

  • 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.

    PubMed 34130731

  • 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.

    PubMed 32975711

  • 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.

    PubMed 31542292

  • 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.

    PubMed 30576013

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing vildagliptin and Metformin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 227 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 sites in Slovakia, Germany, India, Brazil, Russia and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Initial Treatment Failure (time frame: Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01528254, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.

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