A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.

Key facts

Study ID

NCT02038764

Run by

Pfizer

People needed

37

Starts

2014-06-04

Expected to finish

2016-09-13

Last updated by the study team

2018-08-03

Who can join

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

You may qualify if…

• Women and men age 18 and older.
• Diagnosis of type 1 diabetes within 2 years of randomization.
• Peak stimulated C-peptide levels ≥ 0.15 ng/mL.

You may not qualify if…

• Anticipated ongoing use of diabetes medications other than insulin.
• Evidence or history of diabetic complications with significant end-organ damage.
• Episode of severe hypoglycemia within 60 days of randomization.
• Multiple hospitalizations for diabetic ketoacidosis.

Where it is running

• VA San Diego Healthcare System (Drug Shipment) — San Diego, California, United States
• Veterans Administration San Diego Healthcare System — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Barbara Davis Center — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Yale New Haven Hospital - Investigational Drug Services — New Haven, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Duchossois Center for Advanced Medicine — Chicago, Illinois, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• University of Chicago Clinical Resource Center — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Umass Memorial Medical Center — Worcester, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• University Of Minnesota Fairview Pharmacy Services — Minneapolis, Minnesota, United States
• University Of Minnesota Medical School — Minneapolis, Minnesota, United States
• Barnes- Jewish HOSP Att: Kathryn Vehe — St Louis, Missouri, United States
• Washington University - Center for Advanced Medicine — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Duke Clinical Research Unit — Durham, North Carolina, United States
• Duke University Health Systems (DUHS) Investigational Drug Services — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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