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Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102466
First Posted: January 31, 2005
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study is not being conducted in the United States. Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Change from baseline in HbA1c at 52 weeks [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • Adverse event profile after 52 weeks of treatment [ Time Frame: 52 weeks ]
  • Change from baseline in fasting plasma glucose at 52 weeks [ Time Frame: 52 weeks ]
  • Patients with endpoint HbA1c <7% at 52 weeks [ Time Frame: 52 weeks ]
  • Patients with reduction in HbA1c >/= 0.7% after 52 weeks [ Time Frame: 52 weeks ]
  • Patients with reduction in HbA1c >/= 0.5% after 52 weeks [ Time Frame: 52 weeks ]

Enrollment: 1007
Study Start Date: January 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin Drug: vildagliptin Drug: Metformin
Active Comparator: Gliclazide Drug: Gliclazide Drug: Metformin

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On a stable dose of metformin as defined by the protocol
  • Blood glucose criteria must be met
  • Body mass index (BMI) in the range 22-45

Exclusion Criteria:

  • Pregnancy or lactation
  • Type 1 diabetes
  • Evidence of significant diabetic complications
  • Evidence of serious cardiovascular complications
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102466


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

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00102466     History of Changes
Other Study ID Numbers: CLAF237A2338
First Submitted: January 29, 2005
First Posted: January 31, 2005
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
type 2 diabetes
vildagliptin

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