Status:
COMPLETED
Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 d...
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), t...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2019
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT03406377
Start Date
April 2 2018
End Date
June 27 2019
Last Update
June 15 2021
Active Locations (3)
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1
National Research Institute - Huntington Park
Huntington Park, California, United States, 90255
2
National Research Institute - Wilshire
Los Angeles, California, United States, 90057
3
Clinical Pharmacology of Miami, LLC
Hialeah, Florida, United States, 33014