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.

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.

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.

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.