Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00110240
First received: May 4, 2005
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • Change from baseline in HbA1c at 24 weeks for subset of Chinese patients
  • Overall adverse event profile after 24 weeks of treatment
  • Gastrointestinal side effect profiles after 24 weeks of treatment
  • Change from baseline in fasting plasma glucose at 24 weeks
  • Patients with endpoint HbA1c <7% after 24 weeks

Enrollment: 594
Study Start Date: April 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Not currently on drug therapy for type 2 diabetes
  • Body mass index (BMI) in the range 20-40
  • Blood glucose criteria must be met

Exclusion Criteria:

  • Pregnancy or lactation
  • Type 1 diabetes
  • Evidence of significant diabetic complications
  • Evidence of serious cardiovascular conditions
  • 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: NCT00110240

Locations
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
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: NCT00110240     History of Changes
Other Study ID Numbers: CLAF237A2323
Study First Received: May 4, 2005
Last Updated: May 4, 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
Acarbose
Vildagliptin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014