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NCT03795389 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Diabetes and Chronic Kidney Disease, sponsored by DiaMedica Therapeutics.

Completed
Registry status
Phase 1
Development phase
33
Enrollment target
3
Study locations

NCT03795389 is a Phase 1 study of Diabetes and Chronic Kidney Disease that has completed, run by DiaMedica Therapeutics. The registered enrollment target is 33 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT03795389, a Phase 1 study of Diabetes and Chronic Kidney Disease, has completed, sponsored by DiaMedica Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
33 participants
Enrollment target
3
Study locations

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

3 total trials

What the Registry Record Tells You About NCT03795389

The ClinicalTrials.gov registry entry for NCT03795389 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower). The listed sponsor is DiaMedica Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

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.

NCT03795389 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Florida, Minnesota.

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).

What interventions are being tested in trial NCT03795389?

The interventions under investigation include: DM199 (DRUG).

Who is sponsoring clinical trial NCT03795389?

This trial is sponsored by DiaMedica Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

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.

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

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