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COMPLETED Phase 1

Study to Assess PK, Safety and Tolerability in Patients With DM and CKD

NCT03795389 · View on ClinicalTrials.gov ↗

Study Summary

An open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease. The primary objectives of this study are to evaluate safety, tolerability, and PK profile of DM199 in these subjects.

Interventions

  • DRUG DM199

Study Locations (3)

Florida

  • Clinical Pharmacology of Miami — Hialeah
  • Orlando Clinical Research Center Inc — Orlando

Minnesota

  • Prism Research — Saint Paul

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2019-02-12
Est. Completion 2019-07-21
Phase Phase 1

Sponsor

DiaMedica Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03795389

The ClinicalTrials.gov registry entry for NCT03795389 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DiaMedica Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Diabetes appearing as the primary indexed condition, and to 1 intervention — of which DM199 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03795389 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Florida, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03795389 about?

NCT03795389 is a clinical study titled "Study to Assess PK, Safety and Tolerability in Patients With DM and CKD". An open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease. The primary objectives of this study are to evaluate safety, tolerability, and PK profile of DM199 in these subjects.

What is the current status of trial NCT03795389?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2019-02-12. Estimated completion is 2019-07-21.

What conditions does trial NCT03795389 study?

This clinical trial studies the following conditions: Diabetes, Chronic Kidney Disease, Chronic Kidney Disease, Stage 3 (Moderate), Chronic Kidney Disease, Stage 4 (Severe). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03795389?

The interventions under investigation include: DM199 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03795389?

This trial is sponsored by DiaMedica Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03795389 being conducted?

This trial has 3 study locations across Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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