type 2 diabetic patients with proteinuria and chronic renal failure due to overt diabetic nephropathy
Conditions
Interventions
Trade Name: Avandia 4mg Filmtabletten
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Rosiglitazone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharm
Sponsors
Technical University Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -type 2 diabetes mellitus -age between 40 and 70 years -well controlled HbA1c ( 300 mg / 24 hours Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -type 1 diabetes -poorly controlled type 2 diabetes (HbA1c > 7.5%) or unstable blood glucose during the day (capillary blood glucose self monitoring) -elevation of ALT, AST or GGT more than 2.5 fold the upper normal value -CHF (more than grade 1 of NYHA) -uncontrolled hypertension -malignant tumorous disorder -hyper- or hypothyroidism -pregnant women -nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of the efficacy of rosiglitazone on urinary protein excretion in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy.;Secondary Objective: Investigation of the efficacy of rosiglitazone on glomerular filtration rate, renal plasma flow and insulin sensitivity index in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy. Investigation of the safety of rosiglitazone treatment in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy. ;Primary end point(s): urinary protein excretion within 24 hours after 52 weeks of treatment | — |
Countries
Germany
Outcome results
None listed