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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00106340
First received: March 22, 2005
Last updated: December 28, 2012
Last verified: December 2012
History of Changes
  Purpose

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 long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride 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: glimepiride
Drug: Metformin
Drug: Vildagliptin matching placebo
Drug: Glimepiride matching placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Time to HbA1c >8% [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in HbA1c at 5 years [ Time Frame: 2 years (amended) ] [ Designated as safety issue: No ]
  • Adverse event profile after 5 years of treatment [ Time Frame: 2 years (amended) ] [ Designated as safety issue: Yes ]
  • Coefficient of failure for HbA1c from week 24 to 5 years [ Time Frame: 2 years (amended) ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose at 5 years [ Time Frame: 2 years (amended) ] [ Designated as safety issue: No ]
  • Change from baseline in body weight at 5 years [ Time Frame: 2 years (amended) ] [ Designated as safety issue: No ]

Enrollment: 3118
Study Start Date: March 2005
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin Drug: vildagliptin
Other Name: LAF237, Galvus
Drug: Metformin Drug: Glimepiride matching placebo
Active Comparator: Glimepiride Drug: glimepiride Drug: Metformin Drug: Vildagliptin matching placebo

  Eligibility

Ages Eligible for Study:   18 Years to 73 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On a stable dose of metformin as defined by the protocol
  • 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 complications
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106340

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Germany
Investigative Centers
Nurnberg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00106340     History of Changes
Other Study ID Numbers: CLAF237A2308
Study First Received: March 22, 2005
Last Updated: December 28, 2012
Health Authority: United States: Food and Drug Administration

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
Glimepiride
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013