Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.

Key facts

Study ID

NCT00821977

Run by

Novartis

People needed

338

Starts

2008-11-01

Expected to finish

2010-10-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients at least 18 years of age at Visit 1
• Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
• HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
• Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1

You may not qualify if…

• Pregnant or lactating female
• FPG ≥ 270 mg/dL (≥15 mmol/L)
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Horizon Clinical Research Associates, PLLC — Gilbert, Arizona, United States
• Vista Medical Research, Inc — Mesa, Arizona, United States
• Clinical Research Advantage — Mesa, Arizona, United States
• Hope Clinical Research — Phoenix, Arizona, United States
• Anasazi Internal Medicine — Phoenix, Arizona, United States
• Tatum Ridge Internal Medicine — Phoenix, Arizona, United States
• Paradigm Clinical — Tucson, Arizona, United States
• Tucson Clinical Research — Tucson, Arizona, United States
• Medical Investigations, Inc. — Little Rock, Arkansas, United States
• Paul W. Davis, MD — Pine Bluff, Arkansas, United States
• Sall Research Medical Center — Artesia, California, United States
• Associated Pharmaceutical Research — Buena Park, California, United States
• Providence Research — Burbank, California, United States
• Burbank - Lovelace Scientific Resources, Inc. — Burbank, California, United States
• Lucita M. Cruz, M.D., Inc. — Norwalk, California, United States
• California Research Foundation — San Diego, California, United States
• Ritchken and First MDs — San Diego, California, United States
• San Diego Sports Medicine Research and Family Care — San Diego, California, United States
• Crest Clinical Trials — Santa Ana, California, United States
• NuLife Clinical Research, Inc. — Santa Ana, California, United States
• Westside Arthritis and Metabolism Center — Santa Monica, California, United States
• Center for Clinical Trials of San Gabriel — West Covina, California, United States
• Colorado Springs Health Partners, Pc — Colorado Springs, Colorado, United States
• Express Care Clinical Research — Colorado Springs, Colorado, United States
• Advanced Clinical Research — Pell City, Alabama, United States

Full record on ClinicalTrials.gov

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