Trials / Completed
CompletedNCT03449199
Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess Safety, Tolerability, and Renal Effects of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 130 (actual)
- Sponsor
- Teijin America, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TMX-049 | A certain dose of TMX-049 to be taken orally, once daily |
| DRUG | Placebo | Matching placebo to be taken orally, once daily |
Timeline
- Start date
- 2018-04-10
- Primary completion
- 2019-05-07
- Completion
- 2019-06-04
- First posted
- 2018-02-28
- Last updated
- 2022-08-30
- Results posted
- 2022-08-01
Locations
55 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03449199. Inclusion in this directory is not an endorsement.