Status:
COMPLETED
Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin
Lead Sponsor:
Pfizer
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2011
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00970593
Start Date
September 2 2009
End Date
July 25 2011
Last Update
November 2 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Profil Institute for Clincal Research
Chula Vista, California, United States, 91911
2
Cetero Research - Miami
Miami Gardens, Florida, United States, 33169