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.

• Status: Completed
• Trial end date: 2013-10-01

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.

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human