Overview

Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy

Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mitsubishi Tanabe Pharma Corporation
Criteria
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