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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Metabolic Diseases

Glucose Metabolism Disorders

Diabetes Mellitus

Diabetes Mellitus, Type 2

Endocrine System Diseases

Treatments

Biological: Placebo

Biological: PF-04856883

Study type

Interventional

Funder types

Industry

Identifiers

NCT01301456

B1111002

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

84 participants in 13 patient groups, including a placebo group

Treatment Arm 1 (Stage 1A)

Placebo Comparator group

Treatment:

Biological: Placebo

Treatment Arm 2 (Stage 1A)

Experimental group

Treatment:

Biological: PF-04856883

Treatment Arm 3 (Stage 1A)

Experimental group

Treatment:

Biological: PF-04856883

Treatment Arm 4 (Stage 1A)

Experimental group

Treatment:

Biological: PF-04856883

Treatment Arm 5 (Stage 1B)

Placebo Comparator group

Treatment:

Biological: Placebo

Treatment Arm 6 (Stage 1B)

Experimental group

Treatment:

Biological: PF-04856883

Treatment Arm 7 (Stage 1B)

Experimental group

Treatment:

Biological: PF-04856883

Treatment Arm 8 (Stage 1B)

Experimental group

Treatment:

Biological: PF-04856883

Treatment Arm 9 (Stage 2)

Placebo Comparator group

Treatment:

Biological: Placebo

Treatment Arm 10 (Stage 2)

Experimental group

Treatment:

Biological: PF-04856883

Treatment Arm 11 (Stage 2)

Experimental group

Treatment:

Biological: PF-04856883

Treatment Arm 12 (Stage 2)

Experimental group

Treatment:

Biological: PF-04856883

Treatment Arm 13 (Stage 2)

Experimental group

Treatment:

Biological: PF-04856883

Trial contacts and locations

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trials Trials by location

Research sites

Find research sites Learn about CTV for professionals

Resources

Contact CTV support

Legal

Privacy Notice Terms