Type 2 Diabetes Mellitus Clinical Trial
Official title:
Subcutaneous Insulin Glargine Versus NPH Insulin in Patients With Chronic Kidney Disease Stages III and IV: Randomized Controlled Trial.
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.
This study consists of a randomized, cross-over, open-label controlled clinical trial.
Randomized patients will be allocated alternately into two groups to receive the following
therapies: GROUP 1 - insulin analog glargine once a day associated to insulin lispro at
mealtime and GROUP 2 - NPH human insulin, three applications per day ( breakfast, lunch and
bedtime) and insulin lispro at mealtime. Patients receiving insulin NPH plus insulin lispro
will be oriented to mix both of them in the same syringe at breakfast and lunchtime. The
laboratory tests will be performed at baseline and 12, 24, 36 and 48 weeks after the study
start. During routine medical appointments the patient should bring the self- monitoring of
capillary blood glucose (SMBG), eight points per day once a week, and hypoglycemia score.
After 24 weeks of insulin therapy, a continuous glucose monitoring system (CGMS) will be
implemented for three days, and after that, the basal insulin changed i.e. patients using NPH
insulin will receive insulin glargine and patients on insulin glargine will be changed to NPH
insulin, both groups will keep insulin lispro before meals. A new CGMS will be carried out 24
weeks after therapy has been changed. Methodology: The metabolic profile will be evaluated
throughout SMBG; biochemical, hormonal and hematological measurements; hypoglycemia score and
CGMS (Medtronic/Northridge, CA). All randomized patients who use at least one dose of any
study treatment will be considered in the Intent-to-treat (ITT) population. The initial plan
is to randomize 40 patients, assuming a drop-out rate of 15%, to obtain a sample size of at
least 34 randomized patients. .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.
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