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

A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect on Urine Albumin-to-Creatinine Ratio (UACR), Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of MT-3995 as Add-on Therapy to ACE-I or ARB in Type II Diabetic Nephropathy Subjects With Albuminuria and an eGFR ≥60 mL/Min/1.73m^2

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01756703

Enrollment

Registered

2012-12-27

Start date

2012-11-30

Completion date

2014-08-31

Last updated

2015-02-09

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 pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria

Interventions

DRUGMT-3995 Low

MT-3995 Low dose for 8 weeks

DRUGMT-3995 High

MT-3995 High dose for 8 weeks

DRUGPlacebo

Placebo for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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) ≥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

Design outcomes

Primary

Measure	Time frame
Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.	up to 8 weeks
Frequency and nature of treatment-emergent adverse events and serious adverse events.	up to 16 weeks

Secondary

Measure	Time frame
Percentage change from baseline in UACR compared to placebo	up to 8 weeks
Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.	up to 8 weeks
Plasma concentrations of MT-3995 and its major metabolite	up to 16 weeks

Countries

Bulgaria, Hungary, Lithuania, Romania, Slovakia

Outcome results

None listed

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