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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03406377

Run by

OPKO Health, Inc.

People needed

113

Starts

2018-04-02

Expected to finish

2019-06-27

Last updated by the study team

2021-06-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women aged 18 to 80 years with T2DM treated with diet and exercise alone or on a stable dose of metformin (≥ 1000 mg/day),
• BMI ≥27 and ≤45 kg/m2
• HbA1c ≥7.0% and ≤10.5% at screening

You may not qualify if…

• Type 1 diabetes mellitus
• Previous treatment with incretin mimetic drugs
• Have used insulin for diabetic control for more than 6 consecutive days within the prior year
• Have had two or more emergency room visits or hospitalizations due to poor glucose control within the prior 6 months
• Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase (>2 x ULN).

Where it is running

• National Research Institute - Huntington Park — Huntington Park, California, United States
• National Research Institute - Wilshire — Los Angeles, California, United States
• Clinical Pharmacology of Miami, LLC — Hialeah, Florida, United States

Full record on ClinicalTrials.gov

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