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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00099944
First received: December 21, 2004
Last updated: May 3, 2012
Last verified: May 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 safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: vildagliptin
Drug: Glimepiride
Drug: LAF237 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: Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes

Resource links provided by NLM:

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

Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose at 24 weeks
  • Patients with endpoint HbA1c <7% after 24 weeks
  • Patients with reduction in HbA1c >/=to 0.7% after 24 weeks
  • Adverse event profile after 24 weeks of treatment
  • Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs. low baseline HbA1c

Enrollment: 515
Study Start Date: May 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAF237 50 mg qd + glimepiride 4 mg qd
LAF237 50 mg qd + glimepiride 4 mg qd
 Drug: vildagliptin Drug: Glimepiride
Glimepiride 4 mg qd
Experimental: LAF237 50 mg bid + glimepiride 4 mg qd
LAF237 50 mg bid + glimepiride 4 mg qd
 Drug: vildagliptin Drug: Glimepiride
Glimepiride 4 mg qd
Placebo Comparator: LAF237 placebo + glimepiride 4 mg qd
LAF237 placebo + glimepiride 4 mg qd
 Drug: Glimepiride
Glimepiride 4 mg qd
Drug: LAF237 placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Blood glucose criteria must be met
  • Previously treated with a sulfonylurea for at least 3 months
  • Body mass index (BMI) in the range 22-45

Exclusion Criteria:

  • Type 1 diabetes
  • Pregnancy or lactation
  • Evidence of serious cardiovascular complications
  • Evidence of serious diabetic complications
  • Laboratory value abnormalities as defined by the protocol
  • Known sensitivity to glimepiride
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099944

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
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00099944     History of Changes
Other Study ID Numbers: CLAF237A2305
Study First Received: December 21, 2004
Last Updated: May 3, 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
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