Type 2 Diabetes Mellitus, Nephropathy
Conditions
Keywords
Type 2 diabetes mellitus, Nephropathy, valsartan, probucol, Proteinuria
Brief summary
This is a prospective randomized controlled, open-labeled study to identify the efficacy of probucol in combination with valsartan in patients with Diabetes nephropathy. The reduction of urinary albumin or proteinuria will be the primary outcome studied. The expected study duration will be 48 weeks.
Detailed description
a prospective randomized controlled, open-labeled study in patients with Diabetes nephropathy * Arm 1: Valsartan + Probucol Valsartan (160mg/day) + Probucol (750mg/day) * Arm 2: Valsartan + Placebo Valsartan (160mg/day) + Placebo
Interventions
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes nephropathy * Urinary albumin excretion 1-3g/24hours * Serum creatinine \< 3mg/dl
Exclusion criteria
* Type 1 diabetes mellitus * Renal diseases other than type 2 Diabetes nephropathy * Renal artery stenosis * Severe heart diseases * Tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| urinary albumin excretion or proteinuria at week 48 | 48 weeks |
Countries
China
Outcome results
None listed