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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014