Last updated on April 2018

Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects

Brief description of study

This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC) OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.

Detailed Study Description

This clinical trial is a phase 2, double-blind dose escalation regimen of once-weekly OPK-88003 in subjects with T2DM. The trial consists of four phases: a screening/baseline phase (up to 2 weeks prior to first dose), a 30-week treatment period consisting of a dose escalation phase (8 weeks) and a target dose phase (22 weeks), and a follow-up period (4 weeks). Subjects will be randomly assigned to volume-matched OPK-88003 or placebo administered QW.

Clinical Study Identifier: NCT03406377

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Stanley Hsin-Wei Hsia

National Research Institute - Huntington Park
Huntington Park, CA United States
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Juan Pablo Frias

National Research Institute - Wilshire
Los Angeles, CA United States
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Kenneth Lasseter, MD

Clinical Pharmacology of Miami, LLC
Hialeah, FL United States
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Recruitment Status: Open

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