Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin
Completed · Phase 1 · Has a placebo group
Conditions studied: Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT00970593
- Run by
- Pfizer
- People needed
- 92
- Starts
- 2009-09-02
- Expected to finish
- 2011-07-25
- Last updated by the study team
- 2020-11-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Profil Institute for Clincal Research — Chula Vista, California, United States
- Cetero Research - Miami — Miami Gardens, Florida, United States
Full record on ClinicalTrials.gov
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