Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy
- Registration Number
- NCT02205372
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
- Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
- Glycosylated haemoglobin (HbA1c) ≤10.5%
- Subject with albuminuria
Exclusion Criteria
- Subjects with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus (Cushing's syndrome, steroidogenic diabetes).
- Serum potassium level <3.5 or >5.0 mmol/L
- Subjects who had acute kidney injury within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation
- Subjects with clinically significant hypotension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - MT-3995 MT-3995 -
- Primary Outcome Measures
Name Time Method Frequency and nature of treatment-emergent adverse events and serious adverse events. 20 weeks
- Secondary Outcome Measures
Name Time Method Plasma concentrations of MT-3995 20 weeks Plasma concentrations of major metabolite of MT-3995 20 weeks Change from baseline in Urine albumin-to-creatinine ratio (UACR) 20 weeks Change from baseline in blood pressure 20 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of MT-3995 in mitigating diabetic nephropathy progression?
How does MT-3995 compare to standard-of-care agents like ACE inhibitors in early-stage diabetic nephropathy trials?
Which biomarkers correlate with MT-3995 efficacy in patients with type 1 versus type 2 diabetic nephropathy?
What adverse events were observed in NCT02205372 and how do they align with Mitsubishi Tanabe's other nephroprotective drug trials?
Are there combination therapies involving MT-3995 and SGLT2 inhibitors showing enhanced renal protection in diabetic nephropathy?
Trial Locations
- Locations (1)
Touei Hospital
🇯🇵Sapporo, Hokkaido, Japan
Touei Hospital🇯🇵Sapporo, Hokkaido, Japan