Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: vildagliptin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
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, 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.
Clinical Details
Official title: Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in HbA1c after 24 weeks
Secondary outcome: Change from baseline in fasting plasma glucose at 24 weeksPatients 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
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Additional Information
Starting date: May 2004
Last updated: January 17, 2007
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