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NCT03449199 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
A Phase 2 study, sponsored by Teijin America.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
NCT03449199: Completed Phase 2 study, sponsored by Teijin America.
NCT03449199 is a Phase 2 study that has completed, run by Teijin America. The registered enrollment target is 130 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03449199, a Phase 2 study, has completed, sponsored by Teijin America.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the effect of 2 dose levels of TMX-049 on urinary albumin excretion in subjects with Type 2 diabetes and albuminuria (a urinary albumin-to-creatinine ratio (UACR) 200 to 3000 mg/g and an estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m2). Effects of each TMX-049 dose on UACR will be assessed in terms of ratios using log-transformed UACR at Baseline and after a 12-week period of treatment.
Primary Outcome
UACR from Baseline to Weeks 2, 6, 12, and 16(Follow-up) were measured. The change from baseline at Week 12 in log-transformed UACR was analyzed and reported as a primary outcome.
Interventions
- DRUG Placebo
- DRUG TMX-049
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2018-04-10 |
| Est. Completion | 2019-06-04 |
| Phase | Phase 2 |
What the finished NCT03449199 record still lists
NCT03449199 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03449199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03449199 about?
NCT03449199 is a clinical study titled "Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria". The primary objective of this study is to assess the effect of 2 dose levels of TMX-049 on urinary albumin excretion in subjects with Type 2 diabetes and albuminuria (a urinary albumin-to-creatinine ratio (UACR) 200 to 3000 mg/g and an estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m2). ...
What is the current status of trial NCT03449199?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2018-04-10. Estimated completion is 2019-06-04.
What interventions are being tested in trial NCT03449199?
The interventions under investigation include: Placebo (DRUG), TMX-049 (DRUG).
Who is sponsoring clinical trial NCT03449199?
This trial is sponsored by Teijin America, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03449199's enrollment target sits among peer trials
130 543rd of 2000 higher than 1,448 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
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