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Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females | Clinical Trials | Clareo Health

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

A Phase 1, Double-blind, Placebo-controlled, Randomized, Parallel Group Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-04856883 In Adult Female Subjects With Type 2 Diabetes Mellitus

NCT01301456•Pfizer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (7)

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

Key Dates

Start Date

March 1, 2011

Primary Completion Date

December 1, 2011

Completion Date

April 1, 2012

Last Updated

February 9, 2018

Enrollment

ACTUAL participants

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2Glucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Interventions

Placebo

BIOLOGICAL

PF-04856883

BIOLOGICAL

PF-04856883

BIOLOGICAL

PF-04856883

BIOLOGICAL

Placebo

BIOLOGICAL

PF-04856883

BIOLOGICAL

PF-04856883

BIOLOGICAL

PF-04856883

BIOLOGICAL

Placebo

BIOLOGICAL

PF-04856883

BIOLOGICAL

PF-04856883

BIOLOGICAL

PF-04856883

BIOLOGICAL

PF-04856883

BIOLOGICAL

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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