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

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