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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01528254
First received: February 3, 2012
Last updated: February 12, 2016
Last verified: February 2016
  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 ]
  • Time to initial treatment failure [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Rate of loss in glycemic control in fasting plasma glucose [ Time Frame: Up to 5 years ]
  • Rate of loss in glycemic control in fasting plasma glucose (FPG) during period 2 [ Time Frame: up to 5 years ]
  • 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) ]
  • Number patients with adverse events, death and serious adverse events [ Time Frame: 5 years ]
  • Rate of loss in glycemic control in over time [ Time Frame: up to 5 years ]
  • Rate of change in insulin sensitivity from baseline to end of study (5 years) [ Time Frame: From baseline to end of study (5 years) ]

Enrollment: 2005
Study Start Date: March 2012
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 241 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: 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: February 12, 2016

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
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 20, 2017