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

Mitsubishi Tanabe Pharma logo

Mitsubishi Tanabe Pharma

Status and phase

Completed
Phase 2
Phase 1

Conditions

Diabetic Nephropathy

Treatments

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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