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

NCT03406377 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: DPO-203
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 3

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean Percent (%) Body Weight Change

  From baseline to 30 weeks

• Percent (%) of Subjects With 5% or Greater Body Weight Loss.

  30 weeks.

• Change From Baseline of Fasting Plasma Glucose (FPG).

  30 weeks.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

OPK-88003

EXPERIMENTAL

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

Interventions

OPK-88003 DRUG

OPK-88003 subcutaneous injection

OPK-88003

Placebo DRUG

Placebo subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (3)

National Research Institute - Huntington Park

Huntington Park, California, 90255, United States

Location

National Research Institute - Wilshire

Los Angeles, California, 90057, United States

Location

Clinical Pharmacology of Miami, LLC

Hialeah, Florida, 33014, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: OPKO Health Inc
• Organization: OPKO Health Inc

contact@opko.com

3055754100

Study Officials

• Militza Vera De Alba, MD

  OPKO Health, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 23, 2018
• Study Start: April 2, 2018
• Primary Completion: March 8, 2019
• Study Completion: June 27, 2019
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Locations

US (3)