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Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin

Last updated on February 20, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
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
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects must have been diagnosed with type 2 diabetes, with HbA1c level >=7.0% and

- Men or women of nonchildbearing potential (WONCBP), aged 18 to 65 years inclusive on
study day 1.

- Body mass index in the range of 27 to 40kg/m² (inclusive) and body weight >=50 kg.

- Subjects must be otherwise generally healthy, but may be enrolled with a stable
chronic illness, if it is well controlled and does not interfere with the primary
objective of the study.

- Subjects must currently be treated for diabetes with metformin alone at a total daily
dose of >=1gm (administered QD or BID) and that dose must have been stable for at
least 4 weeks before study day 1.

- Nonsmoker.

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

- Any significant disease with the exception of diabetes mellitus.

- Any surgical or medical condition that may interfere with the absorption,
distribution, metabolism, or excretion of the investigational product.

- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before
study day 1.

- Any clinically important problems in physical examination results, vitals sign
measurements, ECGs, or clinical laboratory test results.

- Positive serologic findings for human immunodeficiency virus (HIV) antibodies,
hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.

- Positive findings of urine drug screen

- Use of any investigational or non-permitted prescription drug within 30 days before
investigational product administration.

NCT00970593
Pfizer
Completed
Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now