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...
Date First Received: May 4, 2005
Last Updated: January 2, 2007
Verified by: Novartis, January 2007
Clinical Trial Phase: Phase 3 | Start Date: April 2005
Overall Status: Completed
Estimated Enrollment: 660
Brief Summary
Official Title: “Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: vildagliptin
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline in HbA1c at 24 weeks
Secondary 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on October 06, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00110240
Study ID Number: CLAF237A2323
ClinicalTrials.gov Identifier: NCT00110240
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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