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

Last updated on August 21, 2018

FOR MORE INFORMATION
Study Location
VA San Diego Healthcare System (Drug Shipment)
San Diego, California, 92161 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 1 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02038764
Pfizer
Completed
A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes

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A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes
A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Doses Of Pf-06342674 (rn168) In Adults With Type 1 Diabetes
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Diabetes Mellitus, Type 1
  • Drug: Placebo
    Placebo
  • Biological: PF-06342674 Dose A
    Multiple SC Doses
  • Biological: PF-06342674 Dose B
    Multiple SC Doses
  • Biological: PF-06342674 Dose C
    Multiple SC Doses
  • Biological: PF-06342674 Dose D
    Multiple SC Doses
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06342674
    Interventions:
    • Biological: PF-06342674 Dose A
    • Biological: PF-06342674 Dose B
    • Biological: PF-06342674 Dose C
    • Biological: PF-06342674 Dose D
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
September 2016
September 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02038764
B4351003
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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