Glargine Versus NPH in Patients With Chronic Kidney Disease
Condition: Type 2 Diabetes Mellitus; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Intervention: Glargine insulin; NPH insulin
Intervention description: The initial insulin dose for those randomized to IGlar was 80% of the total daily NPH dose that was being discontinued. All of them had pre-prandial Regular insulin switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. After 24 weeks, basal insulins were switched; in other words, individuals on IGlar in the first period switched to INPH, and the doses of pre-meal insulin were sustained; The same total daily NPH insulin dose was maintained for those randomized to INPH. All of them had pre-prandial Regular insulin (Humulin R™, Lilly, Brazil) switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. . After 24 weeks, basal insulins were switched; in other words, individuals on NPH in the first period switched to glargine insulin, and the doses of pre-meal insulin were sustained.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Glargine insulin; Chronic Kidney Disease; CGMS

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type 2 diabetes mellitus and chronic kidney disease secondary to
             diabetic nephropathy in stages 3 and 4 (moderate and severe nephropathy, corresponding
             to glomerular filtration rate of 15-59 ml/min/1.73m²) will be included in the study.

        Exclusion Criteria:

          -  Patients with systemic neoplasias,

          -  HIV, chronic kidney disease or nephropathy from other etiologies,

          -  severe psychiatric disorders

          -  pregnant women.