VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus (0)

This study is currently recruiting participants.
Verified May 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01528254
First received: February 3, 2012
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

The purpose of this study is 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 T2DM.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Placebo to vildagliptin
Drug: vildagliptin
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rate of loss in glycemic control over time [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Time to initial treatment failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of loss in glycemic control in fasting plasma glucose [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Rate of loss in glycemic control in fasting plasma glucose (FPG) during period 2 [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Rate of loss of beta cell function from baseline to end of study ( 5 years) [ Time Frame: From baseline to end of study (5 years) ] [ Designated as safety issue: No ]
  • Number patients with adverse events, death and serious adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Rate of loss in glycemic control in over time [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Rate of change in insulin sensitivity from baseline to end of study (5 years) [ Time Frame: From baseline to end of study (5 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: January 2012
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin + vildagliptin Drug: vildagliptin
Patients will be instructed to take one tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food.
Other Name: LAF237
Drug: Metformin
Metformin should be taken in a twice daily (bid) regimen during or after meals at the same time as vildagliptin.
Experimental: Metformin + Placebo of vildagliptin Drug: Placebo to vildagliptin Drug: Metformin
Metformin should be taken in a twice daily (bid) regimen during or after meals at the same time as vildagliptin.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528254

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 293 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01528254     History of Changes
Other Study ID Numbers: CLAF237A23156, 2011-003712-23
Study First Received: February 3, 2012
Last Updated: May 21, 2013
Health Authority: Argentina: National Administration of Drugs, Foods and Medical Technology
Brazil: National Health Surveillance Agency
Bulgaria: Bulgaria Drug Agency
Canada: Health Canada
China: Food and Drug Administration
Colombia:National Institute of Food and Drug Vigilance
Costa Rica: Ministry of Health
Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Guatemala: Ministry of health
Hungary: National Institute of Pharmacy
Hong Kong: Department of Health
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Latvia: State Agency of Medicines
Lithuania: State Medicines Control Agency
Malaysia: Ministry of Health
Mexico: National Institute of Public Health, Health Secretariat
Panama: Ministry of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
Taiwan: Center for Drug Evaluation
Turkey: Ministry of Health
Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:
Type 2 Diabetes Mellitus,
Vildagliptin,
Elderly Patients

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 20, 2014