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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 2, Double-blind Dose Escalation Regimen of Once-Weekly OPK-88003 in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03406377
• Other study ID #: DPO-203
• Status: Completed
• Phase: Phase 2
• Start date: April 2, 2018
• Est. completion date: June 27, 2019

Study information

• Verified date: May 2021
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 27, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• OPK-88003
OPK-88003 subcutaneous injection
• Placebo
Placebo subcutaneous injection

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami, LLC	Hialeah	Florida
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	National Research Institute - Wilshire	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
OPKO Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Percent (%) Body Weight Change	Mean percent (%) body weight change from baseline to after 30 weeks treatment	From baseline to 30 weeks
Secondary	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.
Secondary	Change From Baseline of Fasting Plasma Glucose (FPG).	Change of FPG from baseline to after 30 weeks treatment	30 weeks.