Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00396357

Run by

Novartis Pharmaceuticals

People needed

914

Starts

2006-10-01

Last updated by the study team

2020-12-17

Who can join

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

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.