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

NCT01301456

Last updated date
Study Location
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911, United States
Contact
1-800-718-1021

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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

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Diabetes Mellitus, Type 2 Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System DiseasesSingle-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
NCT01301456
  1. Chula Vista, California
  2. Miami, Florida
  3. Miramar, Florida
  4. Atlanta, Georgia
  5. Omaha, Nebraska
  6. Philadelphia, Pennsylvania
  7. San Antonio, Texas
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Glucose Metabolism Disorders
  • Metabolic Diseases
  • Endocrine System Diseases
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2012)
84
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2011)
54
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01301456
Other Study ID Numbers  ICMJE B1111002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP