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Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00102388
First received: January 29, 2005
Last updated: November 16, 2016
Last verified: November 2016
  Purpose
This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: vildagliptin
Drug: Gliclazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in HbA1c at 104 weeks [ Time Frame: 104 weeks ]

Secondary Outcome Measures:
  • Adverse event profile at 104 weeks [ Time Frame: 104 weeks ]
  • Change from baseline in fasting plasma glucose at 104 weeks [ Time Frame: 104 weeks ]
  • Patients with endpoint HbA1c <7% after 104 weeks [ Time Frame: 104 weeks ]
  • Patients with reduction in HbA1c >/= 0.7% after 104 weeks [ Time Frame: 104 weeks ]
  • Patients with reduction in HbA1x >/= 0.5% after 104 weeks [ Time Frame: 104 weeks ]

Enrollment: 1092
Study Start Date: January 2005
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vildagliptin Drug: vildagliptin
Active Comparator: Gliclazide Drug: Gliclazide

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Not currently on drug therapy for type 2 diabetes
  • Body mass index (BMI) in the range 22-45
  • Blood glucose criteria must be met

Exclusion Criteria:

  • Pregnancy or lactation
  • Type 1 diabetes
  • Evidence of significant diabetic complications
  • Evidence of serious cardiovascular conditions
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol-defined 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: NCT00102388

Locations
Germany
Novartis Investigative Site
Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00102388     History of Changes
Other Study ID Numbers: CLAF237A2310 
Study First Received: January 29, 2005
Last Updated: November 16, 2016

Keywords provided by Novartis:
type 2 diabetes
vildagliptin

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

ClinicalTrials.gov processed this record on February 24, 2017