NCT03406377

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

A Phase 2, Double-blind Dose Escalation Regimen of Once-Weekly OPK-88003 in Subjects With Type 2 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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 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 a screening/baseline (up to 2 weeks prior to first dose), treatment period consisting of a dose escalation (8 weeks) and a target dose (22 weeks), and a follow-up period (4 weeks). Subjects will be randomly assigned to volume-matched OPK-88003 or placebo administered QW.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	OPK-88003	OPK-88003 subcutaneous injection
DRUG	Placebo	Placebo subcutaneous injection

Timeline

• Start date: 2018-04-02
• Primary completion: 2019-03-08
• Completion: 2019-06-27
• First posted: 2018-01-23
• Last updated: 2021-06-15
• Results posted: 2021-06-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study