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.

Summary

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.

Timeline

Start

2010-07

Primary completion

2013-10

Completion

2013-10

Drugs

Indications