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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01935167

Enrollment

158

Registered

2013-09-04

Start date

2013-10-31

Completion date

2015-02-28

Last updated

2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Keywords

Microalbuminuria

Brief summary

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

Detailed 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

Interventions

DRUGDW1029M 600mg

DW1029M 150mg 2 tablets b.i.d

DRUGDW1029M 1200mg

DW1029M 300mg 2 tablets b.i.d

DRUGPlacebo

Placebo 2 tablets b.i.d.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
log ACR	24 weeks after 1st administration	logarithm of the Albumin Creatinine Ratio(ACR) after 24 weeks

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026