Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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16 December 2019 |
Main ID: |
EUCTR2011-003712-23-FI |
Date of registration:
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11/01/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study to compare combination regimen with vildagliptin & metformin versus metformin in treatment-naive patients with type 2 diabetes mellitus
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Scientific title:
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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-naive patients with type 2 diabetes mellitus |
Date of first enrolment:
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08/02/2012 |
Target sample size:
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2000 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003712-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Argentina
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Australia
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Austria
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Brazil
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Bulgaria
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Colombia
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Czech Republic
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Dominican Republic
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Estonia
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Finland
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Germany
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Guatemala
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Hong Kong
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Hungary
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India
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Israel
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Italy
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Korea, Republic of
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Latvia
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Lithuania
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Malaysia
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Mexico
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Norway
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Panama
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Peru
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Philippines
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Poland
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Romania
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Russian Federation
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Slovakia
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South Africa
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Spain
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Taiwan
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Turkey
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Contacts
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Name:
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Clinical Trial Information Desk
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Address:
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Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
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41613241111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Name:
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Clinical Trial Information Desk
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Address:
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Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
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41613241111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Key inclusion & exclusion criteria
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Inclusion criteria: - T2DM diagnosed =24 months ago - HbA1c = 6.5% and =7.5% at visit 1 - Treatment-naive - Body mass index (BMI) = 22 AND=40 kg/M2 at Visit 1
Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: - Pregnant or nursing (lactating) women - Previous or currrent participation in any vildagliptin clinical study - History of hypersensitivity to 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 weeeks or planned regular transfusions during the sutdy period
Other protocol-defined exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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Intervention(s)
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Trade Name: Galvus Product Name: Vildagliptin Product Code: LAF237 Pharmaceutical Form: Tablet INN or Proposed INN: VILDAGLIPTIN CAS Number: 274901-16-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: Sandoz Metformin FC 500 mg Product Name: Metformin Product Code: A10BA02 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: METFORMIN HYDROCHLORIDE CAS Number: 1115-70-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500-
Trade Name: Metformin Hexal ® 500 mg Filmtabletten Product Name: Metformin Product Code: A10BA02 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: METFORMIN HYDROCHLORIDE CAS Number: 1115-70-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500-
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Primary Outcome(s)
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Secondary Objective: - Demonstrate the long-term efficacy of combination of Vildagliptin 50mg bid and metformin over metformin monotherapy in treatment-naive patients with T2DM by testing the hypothesis that the rate of loss in glycemic control over time (estimated annualized slope of HbA1c over time using a random coefficient model) is lower with the combination vildagliptin plus metformin compared to that with metformin monotherapy
Evaluate the effect of initiation of combination regimen with Vildagliptin plus metformin compared with metformin monotherapy in treatment naive patients within up to 5 years of treatment, with regards to: - Progression of HbA1c from 26 weeks after the start of Period 2 to the end of Period 2 assessed by rate of losss in glycemic control over time - Progression of FPG assessed by rate of loss in glycemic control over time assessed by estimated annualized slope of FPG over time for periods defined - Change in HbA1C as defined Other protocol derived Secondary objectives
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Primary end point(s): HbA1c measurement
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Main Objective: - Demonstrate the superiority of combination of vildagliptin 50mg bid and metformin over metformin monotherapy in treatment-naive patients with T2DM by testing the hypothesis that the risk of confirmed initial treatment failure (defined as HbA1c = 7.0%) is lower with the combination of vildagliptin and metformin compared to that with metformin monotherapy
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Timepoint(s) of evaluation of this end point: 5 years
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Secondary Outcome(s)
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Secondary end point(s): - FPG reduction - beta cell function - evaluate the safety and tolerability of vildagliptin in drug-naive T2DM patients
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Timepoint(s) of evaluation of this end point: 5 years
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Secondary ID(s)
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2011-003712-23-LT
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CLAF237A23156
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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