Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy
Phase 1
Completed
- Conditions
- Diabetic Nephropathy
- Interventions
- Drug: MT-3995-LowDrug: PlaceboDrug: MT-3995-High
- Registration Number
- NCT01889277
- 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
- 51
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
- History of Type 1 diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
- 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 MT-3995-Low MT-3995-Low MT-3995-Low Dose Placebo Placebo Placebo MT-3995-High MT-3995-High MT-3995-High Dose
- Primary Outcome Measures
Name Time Method Frequency and nature of treatment-emergent adverse events and serious adverse events. 20 weeks Plasma concentrations of MT-3995 and its major metabolite 20 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in Urine albumin-to-creatinine ratio (UACR) and blood pressure 20 weeks
Trial Locations
- Locations (1)
Koukan Hospital
🇯🇵Kawasaki, Kanagawa Pref., Japan