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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus

Treatments

Drug: placebo comparator
Drug: OAP-189

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

92 participants in 2 patient groups, including a placebo group

OAP-189
Placebo Comparator group
Treatment:
Drug: OAP-189
2
Placebo Comparator group
Treatment:
Drug: placebo comparator

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems