Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes
NCT ID: NCT01285518
Last Updated: 2016-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
84 participants
INTERVENTIONAL
2011-02-28
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment
PF-05231023
0.5 mg QD IV x 1 day
PF-05231023
1.5 mg QD IV x 1 day
PF-05231023
5 mg QD IV x 1 day
PF-05231023
15 mg QD IV x 1 day
PF-05231023
50 mg QD IV x 1 day
PF-05231023
100 mg QD IV x 1 day
PF-05231023
200 mg QD IV x 1 day
Placebo
0.9% w/v sodium chloride injection, USP
Placebo
0.9% w/v sodium chloride injection, USP QD IVx 1 day
Interventions
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PF-05231023
0.5 mg QD IV x 1 day
PF-05231023
1.5 mg QD IV x 1 day
PF-05231023
5 mg QD IV x 1 day
PF-05231023
15 mg QD IV x 1 day
PF-05231023
50 mg QD IV x 1 day
PF-05231023
100 mg QD IV x 1 day
PF-05231023
200 mg QD IV x 1 day
Placebo
0.9% w/v sodium chloride injection, USP QD IVx 1 day
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight \>50 kg (110 lbs).
* HbA1c \>7% and not to exceed 10.5%.
Exclusion Criteria
* Diagnosis of Type 1 diabetes mellitus
* Evidence of diabetic complications with significant end organ damage.
30 Years
65 Years
ALL
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
Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
Fort Meyers, Florida, United States
Elite Research Institute
Miami, Florida, United States
Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)
Miramar, Florida, United States
Cetero Research
San Antonio, Texas, United States
Countries
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Related Links
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Other Identifiers
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B2901001
Identifier Type: -
Identifier Source: org_study_id