Overview

This trial has been completed.

Condition diabetic nephropathy
Treatments mt-3995 low, mt-3995 middle, mt-3995 high, placebo
Phase phase 2
Sponsor Mitsubishi Tanabe Pharma Corporation
Start date July 2015
End date November 2016
Trial size 293 participants
Trial identifier NCT02517320, MT-3995-J05

Summary

The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the first morning void urine sample as an indicator.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, care provider, investigator, outcomes assessor
Arm
(Experimental)
mt-3995 low
(Experimental)
mt-3995 middle
(Experimental)
mt-3995 high
(Placebo Comparator)
placebo

Primary Outcomes

Measure
Change form baseline in UACR
time frame: Week 24

Secondary Outcomes

Measure
Change in UACR classification
time frame: From baseline to 24 weeks
Change in renal function
time frame: From baseline to 24 weeks
Change in serum potassium
time frame: From baseline to 24 weeks
Adverse events
time frame: From baseline to 24 weeks

Eligibility Criteria

All participants from 20 years up to 75 years old.

Inclusion Criteria: - Type 2 diabetes mellitus - Glycated hemoglobin(HbA1c) values (National Glycohemoglobin Standardization Program : NGSP) ≤10.5% - estimated glomerular filtration rate(eGFR) of ≥30 mL/min/1.73 m2 - The median UACR of the first morning void urine samples is ≥50 mg/g Cr and <300 mg/g Cr - Stable blood pressure(diastolic blood pressure (DBP) <100 mmHg and stable systolic blood pressure (SBP) <160 mmHg) Exclusion Criteria: - Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes. - A diagnosis of non-diabetic renal disease. - A following serum potassium level. - eGFR of 30-59mL/min/1.73m2; serum potassium level of <3.5 or >4.7 mmol/L, - eGFR of ≥60mL/min/1.73m2: serum potassium level of <3.5 or >5.0 mmol/L - symptomatic and clinically significant hypotension(diastolic blood pressure(DBP)<50mmHg and systolic blood pressure(SBP)<110mmHg) - QT prolongation or torsades de pointes, or, a history or family history of QT prolongation or torsades de pointes - New York Heart Association (NYHA) Class III or IV heart failure

Additional Information

Official title A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Mitsubishi Tanabe Pharma Corporation.