Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

In brief

The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.

Key facts

Study ID: NCT01301456
Run by: Pfizer
People needed: 84
Starts: 2011-03-01
Expected to finish: 2012-04-01
Last updated by the study team: 2018-02-09

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

History of Type 2 diabetes and currently being treated with high dose metformin
BMI between 22.0 and 40.0 kg/m2
HbA1c between 7.0-10.0%
Fasting C-peptide >1.21 ng/mL

You may not qualify if…

History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications
Treatment with anti-diabetic therapies other than metformin
History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
Males or women of childbearing potential

Where it is running

Profil Institute for Clinical Research, Inc. — Chula Vista, California, United States
Elite Research Institute — Miami, Florida, United States
Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.) — Miramar, Florida, United States
Atlanta Center for Medical Research — Atlanta, Georgia, United States
ICON Clinical Pharmacology, LLC — Omaha, Nebraska, United States
CRI Worldwide, LLC — Philadelphia, Pennsylvania, United States
Healthcare Discoveries LLC d/b/a ICON Development Solutions — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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