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

OPKO Health

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: OPK-88003

Study type: Interventional

Funder types: Industry

Identifiers

NCT03406377

DPO-203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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113 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate

Treatment:

Drug: Placebo

OPK-88003

Experimental group

Description:

70 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks)

Treatment:

Drug: OPK-88003