Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes
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...
Brief Summary
Official Title: “Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes”
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00110240
