Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin
NCT00970593
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Subjects must have been diagnosed with type 2 diabetes, with HbA1c level >=7.0% and <=11.0% and a fasting glucose level <=280 mg/dL.
- 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.
- 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.
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Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin | ||||
Official Title ICMJE | A RANDOMIZED, PARALLEL-GROUP, OPEN-LABEL, PLACEBO CONTROLLED STUDY OF THE EFFECT OF OAP-189 ON THE PHARMACOKINETICS AND PHARMACODYNAMICS OF METFORMIN IN DIABETIC SUBJECTS. | ||||
Brief Summary | This is a study to evaluate the safety, tolerability, and activity of OAP-189 in subjects with type 2 diabetes who are taking metformin for their diabetes. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||
Condition ICMJE | Diabetes Mellitus | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | 92 | ||||
Original Estimated Enrollment ICMJE | 28 | ||||
Actual Study Completion Date ICMJE | July 25, 2011 | ||||
Actual Primary Completion Date | July 25, 2011 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| ||||
Ages ICMJE | 18 Years to 65 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 | NCT00970593 | ||||
Other Study ID Numbers ICMJE | 3283K1-1008 B2201004 ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
| ||||
PRS Account | Pfizer | ||||
Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |