Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 2

Conditions: Diabetic Nephropathy

Treatments: Drug: Placebo; Drug: MT-3995 High; Drug: MT-3995 Low; Drug: MT-3995 Middle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02517320

MT-3995-J05

Details and patient eligibility

About

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.

Enrollment: 293 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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293 participants in 4 patient groups, including a placebo group

MT-3995 Low

Experimental group

Treatment:

Drug: MT-3995 Low

MT-3995 Middle

Experimental group

Treatment:

Drug: MT-3995 Middle

MT-3995 High

Experimental group

Treatment:

Drug: MT-3995 High

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo