Type 2 Diabetes Mellitus MedDRA version: 19.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Galvus
Product Name: Vildagliptin
Product Code: LAF237
Pharmaceutical Form: Tablet
INN or Proposed INN: VILDAGLIPTIN
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion 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
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 8 weeeks or planned regular transfusions during the study period Other protocol-defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ; 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 ;Primary end point(s): HbA1c measurement;Timepoint(s) of eva | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 5 years; Secondary end point(s): - FPG reduction - beta cell function - evaluate the safety and tolerability of vildagliptin in drug-naive T2DM patients | — |
Countries
Argentina, Austria, Brazil, Bulgaria, Canada, 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, Russian Federation, Slovakia, Spain, Taiwan, Turkey
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma Services Inc. Representative Office
Outcome results
None listed