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

Diabetic Nephropathy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345057
• Other study ID #: CS3150-B-J204
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• CS-3150

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in urinary albumin to creatine ratio (UACR)		Baseline to end of Week 12
Secondary	Transition from microalbuminuria to normoalbuminuria		Baseline to end of Week 12
Secondary	Change in renal function		Baseline to end of Week 12
Secondary	Change in serum potassium		Baseline to end of Week 12