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

Last updated: January 26, 2015
Sponsor: Mitsubishi Tanabe Pharma Corporation
Overall Status: Completed

Phase

1/2

Condition

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Diabetic Kidney Disease

Treatment

N/A

Clinical Study ID

NCT01889277
MT-3995-J03
  • Ages 20-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treatedwith a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensinII receptor blocker (ARB)

  • Glycosylated haemoglobin (HbA1c) ≤10.5%

  • Subject with albuminuria

Exclusion

Exclusion Criteria:

  • History of Type 1 diabetes, pancreas or β-cell transplantation, or diabetes secondaryto 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 haveundergone hemodialysis at any time prior to randomisation

  • Subjects with clinically significant hypotension

Study Design

Total Participants: 51
Study Start date:
July 01, 2013
Estimated Completion Date:
January 31, 2015

Connect with a study center

  • Koukan Hospital

    Kawasaki, Kanagawa Pref.
    Japan

    Site Not Available

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