Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin (3283K1-1008-US)

Pfizer

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus

Treatments

Drug: OAP-189

Drug: placebo comparator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00970593

3283K1-1008

B2201004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

92 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.