Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Subcutaneous Insulin Glargine Versus NPH Insulin in Patients With Chronic Kidney Disease Stages III and IV: Randomized Controlled Trial.
Brief 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.


Options:
A: Arm Label: neutral protamine insulin, metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: insulin detemir | Arm Label: insulin detemir, metformin; Type: EXPERIMENTAL; Interventions: Drug: neutral protamine insulin | Intervention Type: DRUG; Name: insulin detemir; Assigned to Arm(s): neutral protamine insulin, metformin | Intervention Type: DRUG; Name: neutral protamine insulin; Assigned to Arm(s): insulin detemir, metformin
B: Arm Label: Active; Type: EXPERIMENTAL; Interventions: Drug: Insulin Glargine 300 UNT/ML | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Neutral protamine hagedorn insulin | Intervention Type: DRUG; Name: Insulin Glargine 300 UNT/ML; Assigned to Arm(s): Active | Intervention Type: DRUG; Name: Neutral protamine hagedorn insulin; Assigned to Arm(s): Control
C: Arm Label: Insulin detemir; Type: EXPERIMENTAL; Interventions: Drug: insulin detemir | Arm Label: Insulin NPH; Type: ACTIVE_COMPARATOR; Interventions: Drug: insulin NPH | Intervention Type: DRUG; Name: insulin detemir; Assigned to Arm(s): Insulin detemir | Intervention Type: DRUG; Name: insulin NPH; Assigned to Arm(s): Insulin NPH
D: Arm Label: Glargine insulin; Type: EXPERIMENTAL; Interventions: Drug: Glargine insulin | Arm Label: NPH insulin; Type: ACTIVE_COMPARATOR; Interventions: Drug: NPH insulin | Intervention Type: DRUG; Name: Glargine insulin; Assigned to Arm(s): Glargine insulin | Intervention Type: DRUG; Name: NPH insulin; Assigned to Arm(s): NPH insulin

Answer: D