This trial is active, not recruiting.

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 September 2017
Trial size 280 participants
Trial identifier NCT02517320, MT-3995-J05


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
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
mt-3995 low
mt-3995 middle
mt-3995 high
(Placebo Comparator)

Primary Outcomes

Change form baseline in UACR
time frame: Week 24

Secondary Outcomes

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

Male or female 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 October 2016.
Information provided to ClinicalTrials.gov by Mitsubishi Tanabe Pharma Corporation.