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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 1

Treatments

Biological: PF-06342674 Dose C
Biological: PF-06342674 Dose B
Biological: PF-06342674 Dose A
Biological: PF-06342674 Dose D
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02038764
B4351003

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

37 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo
PF-06342674
Experimental group
Treatment:
Biological: PF-06342674 Dose C
Biological: PF-06342674 Dose A
Biological: PF-06342674 Dose D
Biological: PF-06342674 Dose B

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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