A study to compare combination regimen with vildagliptin & metformin versus metformin in treatment-naive patients with type 2 diabetes mellitus

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2011-003712-23-LV
• Date of registration: 11/01/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A study to compare combination regimen with vildagliptin & metformin versus metformin in treatment-naive 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-naive patients with type 2 diabetes mellitus
• Date of first enrolment: 29/02/2012
• Target sample size: 2000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003712-23
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Argentina, Austria, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, Estonia, Finland, Germany, Guatemala, Hong Kong, Hungary, India, Italy, Latvia, Lithuania, Malaysia, Mexico, Norway, Panama, Peru, Philippines, Poland, Romania, Russian Federation, Slovakia, Spain, Taiwan, Turkey, Venezuela, Bolivarian Republic of

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

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 1600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Type 2 Diabetes Mellitus

Intervention(s)

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: Etform 500
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-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 5 years

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 initial treatment failure (defined as HbA1c = 7.0%) is lower with the combination of vildagliptin and metformin compared to that with metformin monotherapy
- 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

Primary end point(s): HbA1c measurement

Secondary Objective: 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
- Safety and tolerability

In a subgroup of patients, to evaluate the effect of initiation of combination regimen compared with metformin monotherapy, with regards to:
- beta cell function assessed by insulin secretion rate (ISR)/glucose area under the curve during a standard meal-test at timepoints indicated
- insulin resistance assessed by oral glucose insulin sensitivity (OGIS) during a standard meal-test at timepoints indicated

Secondary Outcome(s)

Secondary end point(s): - FPG reduction
- beta cell function
- evaluate the safety and tolerability of vildagliptin in drug-naive T2DM patients

Timepoint(s) of evaluation of this end point: 5 years

Secondary ID(s)

CLAF237A23156

2011-003712-23-LT

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date:
Contact: