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

• Status: Completed
• Trial end date: 2019-06-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OPKO Health, Inc.; OPKO Ireland Global Holdings Ltd.
• Collaborator: OPKO Health, Inc.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).