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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Placebo of vildagliptin

vildagliptin

Metformin

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Vildagliptin, Elderly Patients

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Vilda 50mg bid + metformin

Placebo + metformin

Arm Description

Metformin + vildagliptin

Metformin + Placebo of vildagliptin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT01528254

First Posted

February 3, 2012

Last Updated

September 1, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01528254

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

March 30, 2012 (Actual)

Primary Completion Date

April 4, 2019 (Actual)

Study Completion Date

April 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Vildagliptin, Elderly Patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2004 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vilda 50mg bid + metformin

Arm Type

Active Comparator

Arm Description

Metformin + vildagliptin

Arm Title

Placebo + metformin

Arm Type

Experimental

Arm Description

Metformin + Placebo of vildagliptin

Intervention Type

Drug

Intervention Name(s)

Placebo of vildagliptin

Other Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

vildagliptin

Other Intervention Name(s)

LAF237

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to Initial Treatment Failure

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Rate of Loss in Glycemic Control During Period 1

Description

Time Frame

Visit 5 (Week 26) to End of Period 1

Title

Rate of Loss in Glycemic Control in HbA1c Over Time During Period 2

Description

Time Frame

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

Title

Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) During Period 1

Description

Time Frame

Visit 5 (Week 26) to End of Period 1

Title

Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) Over Time During Period 2

Description

Time Frame

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

Title

Rate of Loss of Beta Cell Function From Baseline to End of Study

Description

Time Frame

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

Title

Rate of Change in Insulin Sensitivity From Baseline to End of Study

Description

Time Frame

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

Title

Percentage of Participants With Adverse Events, Serious Adverse Events and Death

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1425AGC

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Isidro

State/Province

Buenos Aires

ZIP/Postal Code

1642

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Capital Federal

ZIP/Postal Code

C1179AAB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1120AAC

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5000AAW

Country

Argentina

Facility Name

Novartis Investigative Site

City

Corrientes

ZIP/Postal Code

3400

Country

Argentina

Facility Name

Novartis Investigative Site

City

Brookvale

State/Province

New South Wales

ZIP/Postal Code

2100

Country

Australia

Facility Name

Novartis Investigative Site

City

Woy Woy

State/Province

New South Wales

ZIP/Postal Code

2256

Country

Australia

Facility Name

Novartis Investigative Site

City

Morayfield

State/Province

Queensland

ZIP/Postal Code

4506

Country

Australia

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A-1130

Country

Austria

Facility Name

Novartis Investigative Site

City

Fortaleza

State/Province

ZIP/Postal Code

60170-320

Country

Brazil

Facility Name

Novartis Investigative Site

City

Fortaleza

State/Province

ZIP/Postal Code

60430-350

Country

Brazil

Facility Name

Novartis Investigative Site

City

Brasilia

State/Province

ZIP/Postal Code

71625-009

Country

Brazil

Facility Name

Novartis Investigative Site

City

Goiania

State/Province

ZIP/Postal Code

74935-530

Country

Brazil

Facility Name

Novartis Investigative Site

City

Belem

State/Province

ZIP/Postal Code

66073-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Curitiba

State/Province

ZIP/Postal Code

80810-040

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90430 001

Country

Brazil

Facility Name

Novartis Investigative Site

City

Mogi das Cruzes

State/Province

ZIP/Postal Code

08780-090

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

04023-900

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

05403 000

Country

Brazil

Facility Name

Novartis Investigative Site

City

São Paulo

State/Province

ZIP/Postal Code

01224-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

São Paulo

State/Province

ZIP/Postal Code

01244-030

Country

Brazil

Facility Name

Novartis Investigative Site

City

Gabrovo

ZIP/Postal Code

5300

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Kazanlak

ZIP/Postal Code

6100

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Razgrad

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Ruse

ZIP/Postal Code

7200

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Smolian

ZIP/Postal Code

4700

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Cartagena

State/Province

Bolivar

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Novartis Investigative Site

City

Baranquilla

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bogotá

Country

Colombia

Facility Name

Novartis Investigative Site

City

Pisek

State/Province

Czech Republic

ZIP/Postal Code

397 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague 5

State/Province

Czech Republic

ZIP/Postal Code

150 30

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brandys Nad Labem

ZIP/Postal Code

250 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha

ZIP/Postal Code

149 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Santo Domingo

State/Province

Republica Dominicana

Country

Dominican Republic

Facility Name

Novartis Investigative Site

City

Santo Domingo

Country

Dominican Republic

Facility Name

Novartis Investigative Site

City

Saku

ZIP/Postal Code

75501

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10117

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

11315

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

11911

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

13415

Country

Estonia

Facility Name

Novartis Investigative Site

City

Lahti

State/Province

Suomi

ZIP/Postal Code

15110

Country

Finland

Facility Name

Novartis Investigative Site

City

Kerava

ZIP/Postal Code

04200

Country

Finland

Facility Name

Novartis Investigative Site

City

Kouvola

ZIP/Postal Code

45100

Country

Finland

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

Novartis Investigative Site

City

Hainstadt

State/Province

Hainburg

ZIP/Postal Code

63512

Country

Germany

Facility Name

Novartis Investigative Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45276

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45329

Country

Germany

Facility Name

Novartis Investigative Site

City

Esslingen am Neckar

ZIP/Postal Code

73728

Country

Germany

Facility Name

Novartis Investigative Site

City

Fulda

ZIP/Postal Code

36037

Country

Germany

Facility Name

Novartis Investigative Site

City

Gelnhausen

ZIP/Postal Code

63571

Country

Germany

Facility Name

Novartis Investigative Site

City

Kamp-Lintfort

ZIP/Postal Code

47475

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

51069

Country

Germany

Facility Name

Novartis Investigative Site

City

Ludwigshafen

ZIP/Postal Code

67059

Country

Germany

Facility Name

Novartis Investigative Site

City

Neuwied

ZIP/Postal Code

56564

Country

Germany

Facility Name

Novartis Investigative Site

City

Saint Ingbert - Oberwuerzbach

ZIP/Postal Code

66386

Country

Germany

Facility Name

Novartis Investigative Site

City

Wangen

ZIP/Postal Code

88239

Country

Germany

Facility Name

Novartis Investigative Site

City

Clinica

ZIP/Postal Code

605

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

010014

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Hong Kong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

HongKong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Zalaegerszeg

State/Province

Zala

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1042

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1212

Country

Hungary

Facility Name

Novartis Investigative Site

City

Csongrad

ZIP/Postal Code

6640

Country

Hungary

Facility Name

Novartis Investigative Site

City

Eger

ZIP/Postal Code

H-3300

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kalocsa

ZIP/Postal Code

6300

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

H 6725

Country

Hungary

Facility Name

Novartis Investigative Site

City

Veszprem

ZIP/Postal Code

H 8200

Country

Hungary

Facility Name

Novartis Investigative Site

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110076

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560003

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560034

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560043

Country

India

Facility Name

Novartis Investigative Site

City

Kochi

State/Province

Kerala

ZIP/Postal Code

682 041

Country

India

Facility Name

Novartis Investigative Site

City

Indore

State/Province

Madhya Pradesh

ZIP/Postal Code

452010

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411004

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411011

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302015

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302023

Country

India

Facility Name

Novartis Investigative Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600 086

Country

India

Facility Name

Novartis Investigative Site

City

Chennai

State/Province

Tamilnadu

ZIP/Postal Code

600008

Country

India

Facility Name

Novartis Investigative Site

City

Chandigarh

ZIP/Postal Code

160 012

Country

India

Facility Name

Novartis Investigative Site

City

Heifa

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91192

Country

Israel

Facility Name

Novartis Investigative Site

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Novartis Investigative Site

City

Rehovot

ZIP/Postal Code

7610001

Country

Israel

Facility Name

Novartis Investigative Site

City

Sefad

ZIP/Postal Code

13100

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

6209804

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Giborim, Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Novartis Investigative Site

City

Montichiari

State/Province

ZIP/Postal Code

25018

Country

Italy

Facility Name

Novartis Investigative Site

City

Campobasso

State/Province

ZIP/Postal Code

86100

Country

Italy

Facility Name

Novartis Investigative Site

City

Arenzano

State/Province

ZIP/Postal Code

16011

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20100

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novartis Investigative Site

City

Casorate Primo

State/Province

ZIP/Postal Code

27022

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Incheon

State/Province

Gyeonggi-do

ZIP/Postal Code

21431

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Suwon

State/Province

Gyeonggi-do

ZIP/Postal Code

442-723

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Uijeongbu-Si

State/Province

Gyeonggi-do

ZIP/Postal Code

480-717

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

03312

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Seocho Gu

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Daejeon

ZIP/Postal Code

301-804

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Incheon

ZIP/Postal Code

403-720

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

150-713

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Jelgava

State/Province

ZIP/Postal Code

3001

Country

Latvia

Facility Name

Novartis Investigative Site

City

Liepaja

State/Province

ZIP/Postal Code

3401

Country

Latvia

Facility Name

Novartis Investigative Site

City

Ogre

State/Province

ZIP/Postal Code

5001

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

1011

Country

Latvia

Facility Name

Novartis Investigative Site

City

Talsi

State/Province

ZIP/Postal Code

3201

Country

Latvia

Facility Name

Novartis Investigative Site

City

Daugavpils

ZIP/Postal Code

LV-5417

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

1057

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV 1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT 50161

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

State/Province

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Jonava

ZIP/Postal Code

55268

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

48259

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

51270

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kota Bahru

State/Province

Kelantan

ZIP/Postal Code

16150

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

56000

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Novartis Investigative Site

City

Ciudad De Mexico

State/Province

Distrito Federal

ZIP/Postal Code

11850

Country

Mexico

Facility Name

Novartis Investigative Site

City

Mexico D.F

State/Province

Distrito Federal

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Novartis Investigative Site

City

México

State/Province

Distrito Federal

ZIP/Postal Code

03800

Country

Mexico

Facility Name

Novartis Investigative Site

City

Cuautla

State/Province

Morelos

ZIP/Postal Code

62746

Country

Mexico

Facility Name

Novartis Investigative Site

City

Cuernavaca

State/Province

Morelos

ZIP/Postal Code

62250

Country

Mexico

Facility Name

Novartis Investigative Site

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

Novartis Investigative Site

City

Distrito Federal

ZIP/Postal Code

14000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Durango

ZIP/Postal Code

34000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Querétaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Enebakk

ZIP/Postal Code

1912

Country

Norway

Facility Name

Novartis Investigative Site

City

Fetsund

ZIP/Postal Code

1900

Country

Norway

Facility Name

Novartis Investigative Site

City

Honefoss

ZIP/Postal Code

3515

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0424

Country

Norway

Facility Name

Novartis Investigative Site

City

Spikkestad

ZIP/Postal Code

3430

Country

Norway

Facility Name

Novartis Investigative Site

City

Panama City

ZIP/Postal Code

0834-01862

Country

Panama

Facility Name

Novartis Investigative Site

City

Panama City

Country

Panama

Facility Name

Novartis Investigative Site

City

Trujillo

State/Province

La Libertad

Country

Peru

Facility Name

Novartis Investigative Site

City

Cercado De Lima

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Chorrillos

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Magdalena

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Isidro

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Martin de Porres

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Arequipa

Country

Peru

Facility Name

Novartis Investigative Site

City

Marikina

State/Province

Metro Manila

ZIP/Postal Code

1810

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon City

State/Province

Metro Manila

ZIP/Postal Code

1109

Country

Philippines

Facility Name

Novartis Investigative Site

City

Marikina City

ZIP/Postal Code

1800

Country

Philippines

Facility Name

Novartis Investigative Site

City

Pasay City

ZIP/Postal Code

1300

Country

Philippines

Facility Name

Novartis Investigative Site

City

Pasig City

ZIP/Postal Code

1600

Country

Philippines

Facility Name

Novartis Investigative Site

City

San Juan City

ZIP/Postal Code

1500

Country

Philippines

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-821

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

61-251

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

61-655

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-349

Country

Poland

Facility Name

Novartis Investigative Site

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Name

Novartis Investigative Site

City

Oradea

State/Province

Bihor

ZIP/Postal Code

410001

Country

Romania

Facility Name

Novartis Investigative Site

City

Oradea

State/Province

Jud. Bihor

ZIP/Postal Code

410619

Country

Romania

Facility Name

Novartis Investigative Site

City

Ploiesti

State/Province

Jud. Prahova

ZIP/Postal Code

100097

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

020045

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

020475

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

Country

Romania

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

101990

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

N.Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Penza

ZIP/Postal Code

440026

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

198260

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

ZIP/Postal Code

214019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St-Petersburg

ZIP/Postal Code

194358

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St.- Petersburg

ZIP/Postal Code

199034

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

85101

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

State/Province

Slovak Republic

ZIP/Postal Code

04001

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Lucenec

State/Province

Slovak Republic

ZIP/Postal Code

98401

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Namestovo

State/Province

Slovak Republic

ZIP/Postal Code

02901

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Roznava

State/Province

Slovak Republic

ZIP/Postal Code

04801

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Sala

State/Province

Slovak Republic

ZIP/Postal Code

92701

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Trebisov

State/Province

Slovak Republic

ZIP/Postal Code

075 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zilina

State/Province

Slovak Republic

ZIP/Postal Code

010 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Banska Bystrica

ZIP/Postal Code

974 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

040 22

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Levice

ZIP/Postal Code

934 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nové Zámky

ZIP/Postal Code

940 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Sabinov

ZIP/Postal Code

08301

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Sered

ZIP/Postal Code

92601

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Sturovo

ZIP/Postal Code

94301

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zilina

ZIP/Postal Code

012 07

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Alberton

ZIP/Postal Code

1449

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Novartis Investigative Site

City

Durban

ZIP/Postal Code

4030

Country

South Africa

Facility Name

Novartis Investigative Site

City

Durban

ZIP/Postal Code

4126

Country

South Africa

Facility Name

Novartis Investigative Site

City

Gauteng

Country

South Africa

Facility Name

Novartis Investigative Site

City

Johannesburg

ZIP/Postal Code

1820

Country

South Africa

Facility Name

Novartis Investigative Site

City

Johannesburg

ZIP/Postal Code

2188

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0184

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

1022

Country

South Africa

Facility Name

Novartis Investigative Site

City

Sant Adria Del Besos

State/Province

Barcelona

ZIP/Postal Code

08930

Country

Spain

Facility Name

Novartis Investigative Site

City

Santa Coloma De Gramanet

State/Province

Barcelona

ZIP/Postal Code

08921

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08025

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08020

Country

Spain

Facility Name

Novartis Investigative Site

City

Hsintien

ZIP/Postal Code

231

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

114

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Novartis Investigative Site

City

Antalya

ZIP/Postal Code

07070

Country

Turkey

Facility Name

Novartis Investigative Site

City

Denizli

ZIP/Postal Code

20070

Country

Turkey

Facility Name

Novartis Investigative Site

City

Diskapi / Ankara

ZIP/Postal Code

06770

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Novartis Investigative Site

City

Kahramanmaras

ZIP/Postal Code

46100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

36170017

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.

Results Reference

derived

PubMed Identifier

34130731

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.

Results Reference

derived

PubMed Identifier

32975711

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.

Results Reference

derived

PubMed Identifier

31542292

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.

Results Reference

derived

PubMed Identifier

30576013

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.

Results Reference

derived

Learn more about this trial

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

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

Type 2 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial