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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: OPK-88003

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 Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Huntington Park, California, United States, 90255
      • National Research Institute - Huntington Park
    • Los Angeles, California, United States, 90057
      • National Research Institute - Wilshire
  • Florida
    • Hialeah, Florida, United States, 33014
      • Clinical Pharmacology of Miami, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate	Drug: Placebo; Placebo subcutaneous injection
EXPERIMENTAL: OPK-88003; 70 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks)	Drug: OPK-88003; OPK-88003 subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c in Subjects With Type 2 DM	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.	From baseline to 30 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: OPKO Health, Inc.
• Investigators: Study Director: Militza Vera De Alba, MD, OPKO Health, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2018
• Primary Completion (ACTUAL): March 8, 2019
• Study Completion (ACTUAL): June 27, 2019

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (ACTUAL): January 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 15, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DPO-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No