Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients

Ajou University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT01382303

AJIRB-MED-CT4-10-055

Details and patient eligibility

About

This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline on proteinuria in Korean type 2 diabetic patients.

Full description

The investigators will recruit adults patients with type 2 diabetes aged over 20 years with spot urine albumin to creatinine ratio over 30mg/g in two consecutive measurements.

Enrolled patients will be randomly assigned to receive pentoxifylline (400mg three times daily) or placebo for 24 weeks.

Fasting blood and spot urine will be collected at baseline, 12 weeks and 24 weeks.

The investigators will evaluate the impact of pentoxifylline on proteinuria in type 2 diabetic patients.

Enrollment: 174 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes mellitus
• age >=20 years
• spot urine albumin/creatinine ratio > 30mg/g in two consecutive measurements
• patients on ACE-inhibitor or ARB as an anti-hypertensive drug
• blood pressure <= 150/100 mmHg
• HbA1c <10%

Exclusion criteria

• taking insulin pentoxifylline, cilostazol, ketas, viagra in 3 months
• ischemic heart disease, stroke, malignant disease, severe infection in 6 months
• serum creatinine > 2.0mg/dl
• severe liver disease or AST, ALT > 3* ULM
• taking systemic steroid in 1 month
• pregnant or plan to become pregnant during the clinical trial
• lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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174 participants in 2 patient groups, including a placebo group

Pentoxifylline

Active Comparator group

Description:

Pentoxifylline 400mg three times a day

Treatment:

Drug: Pentoxifylline

Placebo

Placebo Comparator group

Description:

placebo tablet

Treatment:

Drug: Placebo