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

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus, Type 2 Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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

NCT01301456
Pfizer
Completed
Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females

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Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
A Phase 1, Double-Blind, Placebo-Controlled, Randomized, Parallel Group Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04856883 In Adult Female Subjects With Type 2 Diabetes Mellitus
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Glucose Metabolism Disorders
  • Metabolic Diseases
  • Endocrine System Diseases
  • Biological: Placebo
    Single subcutaneous injection of placebo
  • Biological: PF-04856883
    Single subcutaneous injection of PF-04856883
    Other Name: CVX-096
  • Biological: Placebo
    Multiple weekly subcutaneous injections of placebo for 3 weeks
    Other Name: CVX-096
  • Biological: PF-04856883
    Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
    Other Name: CVX-096
  • Placebo Comparator: Treatment Arm 1 (Stage 1A)
    Intervention: Biological: Placebo
  • Experimental: Treatment Arm 2 (Stage 1A)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 3 (Stage 1A)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 4 (Stage 1A)
    Intervention: Biological: PF-04856883
  • Placebo Comparator: Treatment Arm 5 (Stage 1B)
    Intervention: Biological: Placebo
  • Experimental: Treatment Arm 6 (Stage 1B)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 7 (Stage 1B)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 8 (Stage 1B)
    Intervention: Biological: PF-04856883
  • Placebo Comparator: Treatment Arm 9 (Stage 2)
    Intervention: Biological: Placebo
  • Experimental: Treatment Arm 10 (Stage 2)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 11 (Stage 2)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 12 (Stage 2)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 13 (Stage 2)
    Intervention: Biological: PF-04856883
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
April 2012
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01301456
B1111002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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