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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2011-003712-23
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Secondary ID [2]
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CLAF237A23156
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo of vildagliptin
Treatment: Drugs - vildagliptin
Treatment: Drugs - Metformin
Active Comparator: Vilda 50mg bid + metformin - Metformin + vildagliptin
Experimental: Placebo + metformin - Metformin + Placebo of vildagliptin
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Initial Treatment Failure
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Assessment method [1]
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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.
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Timepoint [1]
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Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
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Secondary outcome [1]
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Rate of Loss in Glycemic Control During Period 1
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Assessment method [1]
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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.
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Timepoint [1]
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Visit 5 (Week 26) to End of Period 1
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Secondary outcome [2]
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Rate of Loss in Glycemic Control in HbA1c Over Time During Period 2
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Assessment method [2]
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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.
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Timepoint [2]
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From 26 weeks after start of Period 2 to end of Period 2
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Secondary outcome [3]
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Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) During Period 1
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Assessment method [3]
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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.
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Timepoint [3]
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Visit 5 (Week 26) to End of Period 1
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Secondary outcome [4]
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Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) Over Time During Period 2
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Assessment method [4]
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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.
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Timepoint [4]
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From 26 weeks after start of Period 2 to end of Period 2
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Secondary outcome [5]
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Rate of Loss of Beta Cell Function From Baseline to End of Study
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Assessment method [5]
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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.
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Timepoint [5]
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Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
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Secondary outcome [6]
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Rate of Change in Insulin Sensitivity From Baseline to End of Study
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Assessment method [6]
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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.
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Timepoint [6]
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Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
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Secondary outcome [7]
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Percentage of Participants With Adverse Events, Serious Adverse Events and Death
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Assessment method [7]
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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.
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Timepoint [7]
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From first dose of study treatment until End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)
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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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/03/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/04/2019
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Sample size
Target
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Accrual to date
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Final
2004
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Novartis Investigative Site - Brookvale
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Recruitment hospital [2]
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Novartis Investigative Site - Woy Woy
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Recruitment hospital [3]
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Novartis Investigative Site - Morayfield
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Recruitment postcode(s) [1]
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2100 - Brookvale
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Recruitment postcode(s) [2]
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2256 - Woy Woy
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Recruitment postcode(s) [3]
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4506 - Morayfield
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Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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Argentina
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Cordoba
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Argentina
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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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Brazil
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Brazil
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Brazil
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SP
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Gabrovo
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Kazanlak
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Plovdiv
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Bulgaria
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Razgrad
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Bulgaria
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Ruse
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Saint Ingbert - Oberwuerzbach
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Clinica
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Eger
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Delhi
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India
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India
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Israel
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BS
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Italy
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CB
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Italy
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GE
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Italy
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Italy
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PV
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Italy
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RM
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LT
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Arequipa
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Philippines
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Metro Manila
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Philippines
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Marikina City
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Philippines
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Pasay City
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Philippines
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Pasig City
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Philippines
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San Juan City
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Poland
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Poznan
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Poland
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Wroclaw
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Poland
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Zabrze
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Romania
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Bihor
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Romania
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Jud. Bihor
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Romania
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Jud. Prahova
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Timisoara
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Russian Federation
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Moscow
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Russian Federation
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N.Novgorod
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Russian Federation
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Penza
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Russian Federation
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Petrozavodsk
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Smolensk
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Russian Federation
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St-Petersburg
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Russian Federation
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St.- Petersburg
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Slovakia
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Slovak Republic
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Slovakia
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Banska Bystrica
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Kosice
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Slovakia
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Levice
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Slovakia
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Nové Zámky
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Slovakia
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Presov
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Slovakia
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Sabinov
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Slovakia
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Sered
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Sturovo
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Zilina
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South Africa
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Alberton
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Cape Town
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South Africa
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Durban
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South Africa
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Gauteng
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South Africa
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Johannesburg
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South Africa
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Pretoria
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Spain
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Barcelona
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Spain
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Cataluña
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Hsintien
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Taipei
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Taoyuan
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Turkey
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Adana
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Turkey
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Antalya
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Turkey
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Denizli
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Turkey
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Diskapi / Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kahramanmaras
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Ethics approval
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01528254
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01528254
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