To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy

Study Overview
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Brief Summary
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Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy

Detailed Description
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A Phase Ⅱ, prospective, 24 weeks, double-blind, placebo-controlled, randomized, multi-center clinical trial for the evaluation of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy

Official Title
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A Phase Ⅱ, Prospective, 24 Weeks, Double-blind, Placebo-controlled, Randomized, Multi-center Clinical Trial for the Evaluation of the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy

Conditions
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Diabetic Nephropathy

Intervention / Treatment
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* Drug: DW1029M 600mg
* Drug: DW1029M 1200mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has confirmed diabetic mellitus prior to 6years Has confirmed microalbuminuria 30   299㎍/㎎creatinine prior to 5months one time and microalbuminuria 30   299㎍/㎎creatinine during screening period Blood Pressure(BP) ≤ 150 / 90 mmHg estimated glomerular filtration rate(eGFR) ≥ 30 ml/min/1.73m2 Hemoglobin A1c(HbA1c) ≤ 9% Low density lipoprotein(LDL-C) ≤ 130mg/dl Exclusion Criteria: kidney or liver disease as follows i.Serum Creatinine > 2.0mg/dl ii.Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 2 x Upper Limit Normal(ULN) iii.Total Bilirubin > 2 x ULN Organic gastrointestinal disorder or Chronic gastroenterologic disorders prior to 6 months as follows [NOTE] Active Crohn's disease, Active ulcerative colitis, Chronic peptic ulcer disease, etc. cardiovascular disease prior to 3 months as follows [NOTE] Unstable angina pectoris, Myocardial infarction, Coronary artery bypass surgery, Percutaneous Transluminal Coronary Angioplasty, transient ischemic attack, cerebrovascular accident etc.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A Group<br>DW1029M 600mg for 24 weeks | Drug: DW1029M 600mg<br>* DW1029M 150mg 2 tablets b.i.d<br>* Other names: DW1029M 150mg 2 tablets;|
| Experimental: B Group<br>DW1029M 1200mg for 24 weeks | Drug: DW1029M 1200mg<br>* DW1029M 300mg 2 tablets b.i.d<br>* Other names: DW1029M 300mg 4 tablets;|
| Placebo Comparator: C Group<br>Placebo for 24 weeks | Drug: Placebo<br>* Placebo 2 tablets b.i.d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| log ACR | logarithm of the Albumin Creatinine Ratio(ACR) after 24 weeks | 24 weeks after 1st administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Log UAE | Urinary Albumin Excretion(UAE) after 12 and 24 weeks | 24 weeks after 1st administration | 
| eGFR | estimated Glomerular Filtration Rate(eGFR) after 12 and 24 weeks | 12 and 24 weeks after 1st administration | 
| log ACR | logarithm of the Albumin Creatinine Ratio(ACR) after 12 weeks | 12 weeks after 1st administration | 
| SCC | Serum Creatinine Concentration(SCC) after 12 and 24 weeks | 12 and 24 weeks after 1st administration | 
| Cystatin C | Cystatin C after 12 and 24 weeks | 12 and 24 weeks after 1st administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microalbuminuria