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Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00099892
Recruitment Status : Completed
First Posted : December 22, 2004
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 safety and effectiveness of two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: vildagliptin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 544 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
Study Start Date : May 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources




Primary Outcome Measures :
  1. Change from baseline in HbA1c after 24 weeks

Secondary Outcome Measures :
  1. Change from baseline in fasting plasma glucose at 24 weeks
  2. Patients with endpoint HbA1c <7% after 24 weeks
  3. Patients with reduction in HbA1c >/=to 0.7% after 24 weeks
  4. Change from baseline in body weight at 24 weeks
  5. Change from baseline in fasting lipids at 24 weeks


Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Type 1 diabetes
  • Pregnancy or lactation
  • Evidence of serious diabetic complications
  • Evidence of serious cardiovascular complications
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol-defined exclusion criteria may apply

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): NCT00099892


Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00099892     History of Changes
Other Study ID Numbers: CLAF237A2303
First Posted: December 22, 2004    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 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
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action