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

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.
ClinicalTrials.gov Identifier: NCT00106340
Recruitment Status : Completed
First Posted : March 23, 2005
Last Update Posted : January 1, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: vildagliptin Drug: glimepiride Drug: Metformin Drug: Vildagliptin matching placebo Drug: Glimepiride matching placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
Study Start Date : March 2005
Primary Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Time to HbA1c >8% [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. Change from baseline in HbA1c at 5 years [ Time Frame: 2 years (amended) ]
  2. Adverse event profile after 5 years of treatment [ Time Frame: 2 years (amended) ]
  3. Coefficient of failure for HbA1c from week 24 to 5 years [ Time Frame: 2 years (amended) ]
  4. Change from baseline in fasting plasma glucose at 5 years [ Time Frame: 2 years (amended) ]
  5. Change from baseline in body weight at 5 years [ Time Frame: 2 years (amended) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 73 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
  • 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

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): 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

Responsible Party: External Affairs, Novartis Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00106340     History of Changes
Other Study ID Numbers: CLAF237A2308
First Posted: March 23, 2005    Key Record Dates
Last Update Posted: January 1, 2013
Last Verified: December 2012

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
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action