A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.

Key facts

Study ID

NCT00468039

Run by

Novartis

People needed

94

Starts

2007-03-06

Expected to finish

2008-06-06

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older, up to 78. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
• Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry
• Body mass index 22-40 kg/meter squared
• HbA1c > 11% and/or FPG >270 mg/dL

You may not qualify if…

• Pregnant or lactating female
• History of type 1 diabetes
• Evidence of significant diabetic complications
• Treatment with insulin or any other oral antidiabetic agent
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Diabetes and Glandular Disease Research Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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