Main
|
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:
|
EUCTR |
Last refreshed on:
|
30 April 2019 |
Main ID: |
EUCTR2011-003712-23-LT |
Date of registration:
|
28/11/2011 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
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:
|
14/03/2012 |
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
|
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
|
Name:
|
Clinical Trial Information Desk
|
Address:
|
Konstitucijos pr. 7
LT-09308
Vilnius
Lithuania |
Telephone:
|
+3705269 1650 |
Email:
|
DRA.Lithuania@novartis.com |
Affiliation:
|
Novartis Pharma Services Inc. Representative Office |
|
Name:
|
Clinical Trial Information Desk
|
Address:
|
Konstitucijos pr. 7
LT-09308
Vilnius
Lithuania |
Telephone:
|
+3705269 1650 |
Email:
|
DRA.Lithuania@novartis.com |
Affiliation:
|
Novartis Pharma Services Inc. Representative Office |
| |
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 8 weeeks or planned regular transfusions during the study period
Other protocol-defined exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
Type 2 Diabetes Mellitus
MedDRA version: 19.0
Level: LLT
Classification code 10045242
Term: Type II diabetes mellitus
System Organ Class: 100000004861
|
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
|
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: Metformine HCL Sandoz 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
|
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
|
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 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
|
Source(s) of Monetary Support
|
Novartis Pharma Services AG
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|