Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.

Study Overview
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Brief Summary
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Primary Objective: >To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group. Secondary Objectives: Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment. Incidence of confirmed symptomatic and nocturnal hypoglycemia. Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover). >Weight variation for each period of treatment. Creatinine clearance at baseline and after each period of treatment. Overall safety: Incidence of adverse events.

Official Title
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National (Brazil), Phase IV, Multicentric, Open Label, Parallel, Comparative Study of the Use of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: INSULIN GLARGINE
* Drug: NPH insulin (insulin isophane)
* Drug: INSULIN GLULISINE
* Drug: Regular insulin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Type 2 diabetes and renal failure in use of NPH regular insulin or fast-acting analog and HbA1c >= 8%. Albuminuria or microalbuminuria diabetic retinopathy. Creatinine clearance < 60 mL/min/1,73 m2 and >30 mL/min/1,73 m2 Exclusion criteria: Hypersensibility to insulin glargine or any other component of the insulin formulation. Use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months. History of diabetic ketoacidosis or positive GAD antibodies. Advanced retinopathy needing laser therapy. Diagnosed advanced neuropathy Severe hepatic disease or active hepatitis. Cardiac failure class III or IV (NYHA). Patients on hemodialysis. Diagnosed cancer. Active infection. Current therapy with steroids. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1: insulin glargine + insulin glulisine<br>insulin glargine once daily + glulisine at meal times | Drug: INSULIN GLARGINE<br>* Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia<br>Drug: INSULIN GLULISINE<br>* Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia<br>|
| Active Comparator: group 2 NPH insulin + regular insulin<br>NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times | Drug: NPH insulin (insulin isophane)<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia<br>Drug: Regular insulin<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%. |  | From visit 1 (Day 1) to visit 13 (Day 169) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL). |  | From baseline and Visit 13 (Day 169) | 
| Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL. |  | From baseline and Visit 13 (Day 169) | 
| Incidence of confirmed severe hypoglycemia: plasma glucose level < 36 mg/dL (2 mmol/L) or with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration |  | From baseline and Visit 13 (Day 169) | 
| Weight variation |  | From baseline to the end of treatment at visit 13 (day 169) | 
| Creatinine clearance variation |  | From baseline to the end of treatment at visit 13 (day 169) |