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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01528254




Registration number
NCT01528254
Ethics application status
Date submitted
3/02/2012
Date registered
7/02/2012
Date last updated
24/09/2020

Titles & IDs
Public title
VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
Scientific 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
Secondary ID [1] 0 0
2011-003712-23
Secondary ID [2] 0 0
CLAF237A23156
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - vildagliptin
Treatment: Drugs - Metformin

Active comparator: Vilda 50mg bid + metformin - Metformin + vildagliptin

Experimental: Placebo + metformin - Metformin + Placebo of vildagliptin


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

Treatment: Drugs: Metformin
Twice daily (bid) regimen during or after meals at the same time as vildagliptin.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Initial Treatment Failure
Timepoint [1] 0 0
Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
Secondary outcome [1] 0 0
Rate of Loss in Glycemic Control During Period 1
Timepoint [1] 0 0
Visit 5 (Week 26) to End of Period 1
Secondary outcome [2] 0 0
Rate of Loss in Glycemic Control in HbA1c Over Time During Period 2
Timepoint [2] 0 0
From 26 weeks after start of Period 2 to end of Period 2
Secondary outcome [3] 0 0
Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) During Period 1
Timepoint [3] 0 0
Visit 5 (Week 26) to End of Period 1
Secondary outcome [4] 0 0
Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) Over Time During Period 2
Timepoint [4] 0 0
From 26 weeks after start of Period 2 to end of Period 2
Secondary outcome [5] 0 0
Rate of Loss of Beta Cell Function From Baseline to End of Study
Timepoint [5] 0 0
Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
Secondary outcome [6] 0 0
Rate of Change in Insulin Sensitivity From Baseline to End of Study
Timepoint [6] 0 0
Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
Secondary outcome [7] 0 0
Percentage of Participants With Adverse Events, Serious Adverse Events and Death
Timepoint [7] 0 0
From first dose of study treatment until End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/04/2019
Sample size
Target
Accrual to date
Final
2004
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Novartis Investigative Site - Brookvale
Recruitment hospital [2] 0 0
Novartis Investigative Site - Woy Woy
Recruitment hospital [3] 0 0
Novartis Investigative Site - Morayfield
Recruitment postcode(s) [1] 0 0
2100 - Brookvale
Recruitment postcode(s) [2] 0 0
2256 - Woy Woy
Recruitment postcode(s) [3] 0 0
4506 - Morayfield
Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Wien
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CE
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Brazil
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DF
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Brazil
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GO
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Brazil
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PA
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Brazil
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PR
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Brazil
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RS
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Brazil
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SP
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Gabrovo
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Gauteng
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Pretoria
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Barcelona
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Hsintien
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Taichung
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Kahramanmaras

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT01528254
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01528254