Overview

A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria and Moderately Decreased GFR

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria and Moderately Decreased GFR
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mitsubishi Tanabe Pharma Corporation
Criteria
Inclusion Criteria:

- Subjects with Type II diabetic nephropathy, who have been treated with angiotensin
converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)

- Glycosylated haemoglobin (HbA1c) ≤10.5%

- An estimated glomerular filtration rate (eGFR) ≥30-<60 mL/min/1.73m^2

- Subject with albuminuria

Exclusion Criteria:

- History of Type I 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 (AKI) within 3 months prior to baseline or have
undergone renal dialysis at any time prior to randomisation

- Subjects with a history of renal transplant

- Subjects with clinically significant hypotension