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Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes

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NCT01285518

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female subjects between the ages of 30 and 65 years, inclusive, with a
historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American
Diabetes Association guidelines.

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

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Diagnosis of Type 1 diabetes mellitus

- Evidence of diabetic complications with significant end organ damage.

NCT01285518
Pfizer
Completed
Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes

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Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes
A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating Intravenous Doses Of Pf-05231023 In Adult Subjects With Type 2 Diabetes
This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: PF-05231023
    0.5 mg QD IV x 1 day
  • Drug: PF-05231023
    1.5 mg QD IV x 1 day
  • Drug: PF-05231023
    5 mg QD IV x 1 day
  • Drug: PF-05231023
    15 mg QD IV x 1 day
  • Drug: PF-05231023
    50 mg QD IV x 1 day
  • Drug: PF-05231023
    100 mg QD IV x 1 day
  • Drug: PF-05231023
    200 mg QD IV x 1 day
  • Other: Placebo
    0.9% w/v sodium chloride injection, USP QD IVx 1 day
  • Experimental: Treatment
    Interventions:
    • Drug: PF-05231023
    • Drug: PF-05231023
    • Drug: PF-05231023
    • Drug: PF-05231023
    • Drug: PF-05231023
    • Drug: PF-05231023
    • Drug: PF-05231023
  • Placebo Comparator: Placebo
    0.9% w/v sodium chloride injection, USP
    Intervention: Other: Placebo
Not Provided


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

Inclusion Criteria:

  • Male and female subjects between the ages of 30 and 65 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American Diabetes Association guidelines.
  • 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:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Diagnosis of Type 1 diabetes mellitus
  • Evidence of diabetic complications with significant end organ damage.
Sexes Eligible for Study: All
30 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01285518
B2901001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2016

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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