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

Dong Wha Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Diabetic Nephropathy

Treatments: Drug: DW1029M 1200mg; Drug: DW1029M 600mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01935167

DW1029M

Details and patient eligibility

About

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

Full description

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

Enrollment: 158 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 3 patient groups, including a placebo group

A Group

Experimental group

Description:

DW1029M 600mg for 24 weeks

Treatment:

Drug: DW1029M 600mg

B Group

Experimental group

Description:

DW1029M 1200mg for 24 weeks

Treatment:

Drug: DW1029M 1200mg

C Group

Placebo Comparator group

Description:

Placebo for 24 weeks

Treatment:

Drug: Placebo