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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 is a Phase 2 study that has completed, run by OPKO Health. The registered enrollment target is 113 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG OPK-88003

Trial Details

FieldValue
Enrollment Target 113 participants
Start Date 2018-04-02
Est. Completion 2019-06-27
Phase Phase 2

Sponsor

OPKO Health

32 total trials

What the Registry Record Tells You About NCT03406377

The ClinicalTrials.gov registry entry for NCT03406377 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OPKO Health, which has 32 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03406377 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.