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

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Diabetic Nephropathy

Treatments: Drug: placebo; Drug: CS-3150

Study type: Interventional

Funder types: Industry

Identifiers

NCT02345057

CS3150-B-J204

Details and patient eligibility

About

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).

Enrollment: 365 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

365 participants in 5 patient groups, including a placebo group

CS-3150 0.625 mg

Experimental group

Description:

One CS-3150 0.625 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.

Treatment:

Drug: CS-3150

Drug: placebo

CS-3150 1.25 mg

Experimental group

Description:

Two CS-3150 0.625 mg tablets administered orally, once daily after breakfast.

Treatment:

Drug: CS-3150

CS-3150 2.5 mg

Experimental group

Description:

One CS-3150 2.5 mg tablet and one placebo tablet to match CS-3150 tablet administered orally, once daily after breakfast.

Treatment:

Drug: CS-3150

Drug: placebo

CS-3150 5.0 mg

Experimental group

Description:

Two CS-3150 2.5 mg tablets administered orally, once daily after breakfast

Treatment:

Drug: CS-3150

Placebo

Placebo Comparator group

Description:

Two placebo tablets to match CS-3150 tablet, administered orally, once daily after breakfast.

Treatment:

Drug: placebo