Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03406377 · ClinicalTrials.gov registry record · Phase 2
Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects
A Phase 2 study, sponsored by OPKO Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
NCT03406377: Completed Phase 2 study, sponsored by OPKO Health.
NCT03406377 is a Phase 2 study that has completed, run by OPKO Health. The registered enrollment target is 113 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03406377, a Phase 2 study, has completed, sponsored by OPKO Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG OPK-88003
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2018-04-02 |
| Est. Completion | 2019-06-27 |
| Phase | Phase 2 |
What the finished NCT03406377 record still lists
NCT03406377 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03406377 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03406377 about?
NCT03406377 is a clinical study titled "Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects". 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 stab...
What is the current status of trial NCT03406377?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2018-04-02. Estimated completion is 2019-06-27.
What interventions are being tested in trial NCT03406377?
The interventions under investigation include: Placebo (DRUG), OPK-88003 (DRUG).
Who is sponsoring clinical trial NCT03406377?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03406377's enrollment target sits among peer trials
113 631st of 2000 higher than 1,370 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00748254 · 113 participants
Laser-based Photoacoustic Tomography of Human Inflammatory Arthritis
- NCT04753190 · 113 participants · NA
Light Timing Study
- NCT05799248 · 113 participants · Phase 3
Role of rhPSMA-7.3 PET/CT Imaging in Men With High-Risk Prostate Cancer Following Conventional Imaging and Associated Changes in Medical Management
- NCT07216105 · 113 participants · Phase 1
FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI