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
Overview
- Phase
- Phase 2
- Intervention
- CS-3150
- Conditions
- Diabetic Nephropathy
- Sponsor
- Daiichi Sankyo
- Enrollment
- 365
- Primary Endpoint
- Change from baseline in urinary albumin to creatine ratio (UACR)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
CS-3150 1.25 mg
Two CS-3150 0.625 mg tablets administered orally, once daily after breakfast.
Intervention: CS-3150
CS-3150 0.625 mg
One CS-3150 0.625 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
Intervention: placebo
CS-3150 0.625 mg
One CS-3150 0.625 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
Intervention: CS-3150
CS-3150 2.5 mg
One CS-3150 2.5 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
Intervention: CS-3150
CS-3150 2.5 mg
One CS-3150 2.5 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.
Intervention: placebo
CS-3150 5.0 mg
Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast
Intervention: CS-3150
Placebo
Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.
Intervention: placebo
Outcomes
Primary Outcomes
Change from baseline in urinary albumin to creatine ratio (UACR)
Time Frame: Baseline to end of Week 12
Secondary Outcomes
- 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)