Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.

Key facts

Study ID

NCT00351884

Run by

Novartis Pharmaceuticals

People needed

370

Starts

2006-05-01

Last updated by the study team

2016-11-18

Who can join

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

You may qualify if…

• Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
• Body mass index in the range 22-40
• Blood glucose criteria must be met

You may not qualify if…

• Pregnancy or lactation
• History of type 1 diabetes
• Evidence of significant diabetic complications
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States
• Novartis Investigative Site — Investigative Centers, Germany

Full record on ClinicalTrials.gov

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