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

This study is currently recruiting participants.
Verified February 2014 by Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation Identifier:
First received: June 26, 2013
Last updated: February 11, 2014
Last verified: February 2014

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

Condition Intervention Phase
Diabetic Nephropathy
Drug: MT-3995-Low
Drug: MT-3995-High
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomised, Double-blind, Placebo-controlled Study of MT-3995 in Subjects With Diabetic Nephropathy

Resource links provided by NLM:

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Frequency and nature of treatment-emergent adverse events and serious adverse events. [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of MT-3995 and its major metabolite [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Urine albumin-to-creatinine ratio (UACR) and blood pressure [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MT-3995-Low
MT-3995-Low Dose
Drug: MT-3995-Low
Experimental: MT-3995-High
MT-3995-High Dose
Drug: MT-3995-High
Placebo Comparator: Placebo
Drug: Placebo


Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01889277

Contact: Clinical Trials Information Desk

Koukan Hospital Recruiting
Kawasaki, Kanagawa Pref., Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Study Director: Masaomi Nangaku, Professor Division of Nephrology and Endocrinology University of Tokyo School of medicine
Study Director: Kazuoki Kondou, Adviser Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT01889277     History of Changes
Other Study ID Numbers: MT-3995-J03
Study First Received: June 26, 2013
Last Updated: February 11, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Diabetic Nephropathy

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases processed this record on April 15, 2014