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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 2

Conditions: Diabetic Nephropathy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01756716

MT-3995-E07

Details and patient eligibility

About

The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria and Moderately Decreased GFR

Enrollment: 49 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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) ≥30-<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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 3 patient groups, including a placebo group

MT-3995 Low group

Experimental group

Treatment:

Drug: MT-3995 Low

MT-3995 High group

Experimental group

Treatment:

Drug: MT-3995 High

Placebo group

Placebo Comparator group

Treatment:

Drug: Placebo