Glargine Versus NPH in Patients With Chronic Kidney Disease
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
Chronic kidney disease (CKD) is one of the most common microvascular complications of
diabetes mellitus, and it is the leading cause of end stage renal disease on developed
countries. The CKD diagnosis and its progression require re-evaluation of hypoglycemic
therapy and constant dosing adjustments, in order to optimize glycemic control and minimize
its side effects. Long acting insulin analogs and its pharmacokinetics have not been studied
through different stages of kidney disease and there is no consensus defining the appropriate
dosing adjustment based on the glomerular filtration rate (GFR). This research project will
compare the glycemic response to intensive insulin treatment with NPH insulin and basal
insulin analog (insulin glargine) in type 2 diabetes (DM 2) patients with CKD stages 3 and 4.
Patients and methods - Inclusion Criteria: DM 2 patients with CKD secondary to diabetic
nephropathy and GFR of 15-59 ml/min/1.73m². Exclusion Criteria: Patients with systemic
neoplasia, HIV, CKD or nephropathy from other etiologies, severe psychiatric disorders and
pregnant women. Study design: This study consists of a randomized, cross-over, open-label
controlled clinical trial. Patients will be randomly divided into two groups: GROUP 1 -
insulin analog glargine once a day and GROUP 2 - NPH human insulin, three applications per
day, both group will be treated with insulin lispro at mealtime. The laboratory tests will be
performed at baseline and 12, 24, 36 and 48 weeks after the study start. During routine
medical appointments will be analyzed self- monitoring of capillary blood glucose (SMBG) and
the hypoglycemia score. After 24 weeks the basal insulin will be changed, i.e. patients using
NPH insulin will receive insulin glargine and patients on insulin glargine will be changed to
NPH insulin. A CGMS will be carried out at 24 and 48 weeks. Methodology: The metabolic
profile will be evaluated throughout SMBG; biochemical, hormonal and hematological
measurements; hypoglycemia score and CGMS. Statistical analysis will be performed using
comparative descriptive analyzes, such as chi-square distribution, t-test and non-parametric
tests. Analyze of data CGMS will include the area under the curve and the related statistic.
Finally, logistic regression models will be adopted to evaluate the effect of the treatment
on the several variables in question.