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

Phase 2

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: CS-3150; Drug: placebo

• Registration Number: NCT02345057
• Lead Sponsor: Daiichi Sankyo

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-26
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CS-3150 0.625 mg	CS-3150	One CS-3150 0.625 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
CS-3150 0.625 mg	placebo	One CS-3150 0.625 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
CS-3150 1.25 mg	CS-3150	Two CS-3150 0.625 mg tablets administered orally, once daily after breakfast.
CS-3150 2.5 mg	CS-3150	One CS-3150 2.5 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
CS-3150 2.5 mg	placebo	One CS-3150 2.5 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
CS-3150 5.0 mg	CS-3150	Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast
Placebo	placebo	Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.

Primary Outcome Measures

Name	Time	Method
Change from baseline in urinary albumin to creatine ratio (UACR)	Baseline to end of Week 12

Secondary Outcome Measures

Name	Time	Method
Transition from microalbuminuria to normoalbuminuria	Baseline to end of Week 12
Change in renal function	Baseline to end of Week 12
Change in serum potassium	Baseline to end of Week 12