diabetes, chronic renal failure
Conditions
Interventions
Patients will be selected consecutively in the nephrology outpatient clinic of the Santa Casa Hospital in Curitiba.
Three groups of patients with type 2 diabetes will be evaluated: 20 patients on hemo
Drug
Device
D06.472.699.587.200.300
Sponsors
Pontifícia Universidade Católica do Paraná
Pontifícia Universidade Católica do Paraná
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Men or women over 18 years; Advanced kidney disease undergoing renal replacement therapy; Type 2 diabetes mellitus on NPH insulin treatment with or without regular insulin for at least 3 months; Glycated hemoglobin greater than 6.5%
Exclusion criteria
Exclusion criteria: Type 1 diabetes mellitus; hypersensitivity to research drugs; treatment with oral glucocorticoids; cancer; women of childbearing age who are pregnant or wish to become pregnant; participation in any other clinical study within the last 90 days prior to the start of this study; abuse of narcotics or alcohol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time measured in minutes out of the range considered adequate for the population (70 to 180 mg/dl for CKD patients not on dialysis and 80 to 180 mg/dl for dialysis patients). For the sample size calculation, we used a significance level of 0.05 (two-sided), a within standard deviation of 60 (min), a power of 0.80 and a minimal detectable difference in means of 60 (min). A total of 18 patients were calculated to enter the trial and after considering the drop-out rate we increased this number to groups of 20. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactCassio Ramos
Pontifícia Universidade Católica do Paraná
Outcome results
None listed