Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone
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: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
Summary
This study is designed to evaluate the efficacy and safety of vildagliptin in combination
with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2
diabetes.
Clinical Details
Official title: A Multicenter, Double-Blind, Randomized Parallel-Group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as Add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment
Secondary outcome: Adverse event profile after 24 weeks of treatmentGastrointestinal tolerability after 24 weeks of treatment Patients with endpoint HbA1c <7% and <6.5% after 24 weeks Patients with reduction in HbA1c >0.7% after 24 weeks Change from baseline in fasting plasma glucose after 24 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: 78 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18-78 years inclusive
- Type 2 diabetes diagnosis at least 2 months prior to study entry
- Body mass index in the range of 22-45 kg/m2
- HbA1c in the range of 6. 5 to 9% inclusive
- Fasting plasma glucose <270 mg/dL (15 mmol/L)
Exclusion Criteria:
- A history of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agents
- Congestive heart failure requiring pharmacologic treatment
- Clinically significant renal dysfunction defined by metformin labeling criteria (serum
creatinine levels >/= 1. 5 mg/dl (males) and >/= 1. 4 mg/dl (females)
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Investigative Centers, Germany
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Additional Information
Starting date: October 2006
Last updated: March 11, 2008
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