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

A Phase II, Randomised, Double-blind, Placebo-controlled Study of MT-3995 in Subjects With Diabetic Nephropathy

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01889277

Enrollment

Registered

2013-06-28

Start date

2013-07-31

Completion date

2015-01-31

Last updated

2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Keywords

Diabetic Nephropathy

Brief summary

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy

Interventions

DRUGMT-3995-Low

DRUGMT-3995-High

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Change from baseline in Urine albumin-to-creatinine ratio (UACR) and blood pressure	20 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026