Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

Key facts

Study ID

NCT00120536

Run by

Novartis

People needed

288

Starts

2005-06-01

Expected to finish

2006-07-01

Last updated by the study team

2017-05-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Not currently on drug therapy for type 2 diabetes
• Blood glucose criteria must be met
• Body mass index (BMI) in the range 22-45

You may not qualify if…

• History of type 1 diabetes
• Evidence of significant diabetic complications
• Serious cardiovascular events within the past 6 months
• Laboratory value abnormalities as defined by the protocol
• Other protocol-defined exclusion criteria may apply

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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