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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: Completed Phase 1 study of Diabetes and Chronic Kidney Disease, sponsored by DiaMedica Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2019-02-12 |
| Est. Completion | 2019-07-21 |
| Phase | Phase 1 |
What the finished NCT03795389 record still lists
NCT03795389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03795389's enrollment target sits among peer trials
33 277th of 338 higher than 62 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes 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.
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