Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
NCT ID: NCT01301456
Last Updated: 2018-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
84 participants
INTERVENTIONAL
2011-03-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Arm 1 (Stage 1A)
Placebo
Single subcutaneous injection of placebo
Treatment Arm 2 (Stage 1A)
PF-04856883
Single subcutaneous injection of PF-04856883
Treatment Arm 3 (Stage 1A)
PF-04856883
Single subcutaneous injection of PF-04856883
Treatment Arm 4 (Stage 1A)
PF-04856883
Single subcutaneous injection of PF-04856883
Treatment Arm 5 (Stage 1B)
Placebo
Single subcutaneous injection of placebo
Treatment Arm 6 (Stage 1B)
PF-04856883
Single subcutaneous injection of PF-04856883
Treatment Arm 7 (Stage 1B)
PF-04856883
Single subcutaneous injection of PF-04856883
Treatment Arm 8 (Stage 1B)
PF-04856883
Single subcutaneous injection of PF-04856883
Treatment Arm 9 (Stage 2)
Placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
Treatment Arm 10 (Stage 2)
PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Treatment Arm 11 (Stage 2)
PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Treatment Arm 12 (Stage 2)
PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Treatment Arm 13 (Stage 2)
PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Interventions
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Placebo
Single subcutaneous injection of placebo
PF-04856883
Single subcutaneous injection of PF-04856883
PF-04856883
Single subcutaneous injection of PF-04856883
PF-04856883
Single subcutaneous injection of PF-04856883
Placebo
Single subcutaneous injection of placebo
PF-04856883
Single subcutaneous injection of PF-04856883
PF-04856883
Single subcutaneous injection of PF-04856883
PF-04856883
Single subcutaneous injection of PF-04856883
Placebo
Multiple weekly subcutaneous injections of placebo for 3 weeks
PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
PF-04856883
Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI between 22.0 and 40.0 kg/m2
* HbA1c between 7.0-10.0%
* Fasting C-peptide \>1.21 ng/mL
Exclusion Criteria
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States
Elite Research Institute
Miami, Florida, United States
Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
Miramar, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
ICON Clinical Pharmacology, LLC
Omaha, Nebraska, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
Healthcare Discoveries LLC d/b/a ICON Development Solutions
San Antonio, Texas, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1111002
Identifier Type: -
Identifier Source: org_study_id
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