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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: OPK-88003

• Registration Number: NCT03406377
• Lead Sponsor: OPKO Health, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-15
• Study First Posted: 2018-01-23
• Study Start: 2018-04-02
• Primary Completion: 2019-03-08
• Study Completion: 2019-06-27
• Results First Submitted: 2021-04-02
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-21
• Last Update Submitted: 2021-05-21
• Results First Posted: 2021-06-15
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
OPK-88003	OPK-88003	70 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks)

Primary Outcome Measures

Name	Time	Method
Change in HbA1c in Subjects With Type 2 DM	From baseline to 30 weeks	To evaluate the effect of dose escalation of QW SC OPK-88003 vs placebo injections on HbA1c absolute change from baseline to after 30 weeks treatment in subjects with T2DM inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline of Fasting Plasma Glucose (FPG).	30 weeks.	Change of FPG from baseline to after 30 weeks treatment
Mean Percent (%) Body Weight Change	From baseline to 30 weeks	Mean percent (%) body weight change from baseline to after 30 weeks treatment
Percent (%) of Subjects With 5% or Greater Body Weight Loss.	30 weeks.	Percent (%) of subjects with 5% or greater body weight loss after 30 weeks treatment

Trial Locations

Locations (3)

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