Skip to main content
OpenTrials
Completed

NCT Number: NCT02345057

A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria

This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese Type 2 Diabetes Mellitus and Microalbuminuria.

The Primary endpoint is the change from baseline in urinary albumin to creatine ratio (UACR).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kumamoto, 862-0976, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with type 2 diabetes mellitus
  • Male or female subjects aged 20 years or older at informed consent
  • Subjects with urinary albumin to creatine ratio (UACR) ≥ 45 mg/g Cr and < 300 mg/g Cr
  • Estimated glomerular filtration rate by creatinine (eGFRcreat) ≥ 30 mL/min/1.73 m^2
  • Subjects treated with angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 3 months prior to treatment period

Exclusion criteria

  • Type 1 diabetes
  • HbA1c (NGSP) >=8.4%
  • Secondary glucose intolerance
  • Subjects diagnosed with non-diabetic nephropathy
  • Nephrotic syndrome
  • Secondary hypertension or malignant hypertension
  • Serum potassium level in any of the following categories: For subjects with eGFRcreat of ≥ 45 mL/min/1.73 m^2, serum potassium level of < 3.5 mEq/L or ≥ 5.1 mEq/L; For subjects with eGFRcreat of ≥ 30 mL/min/1.73 m^2 and < 45 mL/min/1.73 m^2, serum potassium level of < 3.5 mEq/L or ≥ 4.8 mEq/L

Treatment and study plan

CS-3150

Drug

Placebo

Drug

Primary outcomes

  1. Change from baseline in urinary albumin to creatine ratio (UACR)

    Time frame: Baseline to end of Week 12

Secondary outcomes

  1. Transition from microalbuminuria to normoalbuminuria

    Time frame: Baseline to end of Week 12

  2. Change in renal function

    Time frame: Baseline to end of Week 12

  3. Change in serum potassium

    Time frame: Baseline to end of Week 12

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Subjects With Type 2 Diabetes Mellitus and Microalbuminuria

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2015
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.