Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetic Nephropathy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01889277

MT-3995-J03

Details and patient eligibility

About

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy

Enrollment: 51 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
• Glycosylated haemoglobin (HbA1c) ≤10.5%
• Subject with albuminuria

Exclusion criteria

• History of Type 1 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 within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation
• Subjects with clinically significant hypotension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 3 patient groups, including a placebo group

MT-3995-Low

Experimental group

Description:

MT-3995-Low Dose

Treatment:

Drug: MT-3995-Low

MT-3995-High

Experimental group

Description:

MT-3995-High Dose

Treatment:

Drug: MT-3995-High

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo