Recruitment challenges

Primary Objective:

1- Proportion of patients with mean daily glycemia <140mg/dL during the period of 7 days of treatment with glargine plus supplemental glulisine versus patients with glulisine sliding scale.

Secondary Objective:

1. Incidence of moderate hyperglycemia (>140mg/dL) during the treatment period.
2. Incidence of hypoglycemia (<60mg/dL and < 40mg/dL) during the treatment period.
3. Incidence of severe hyperglycemia (>400mg/dL) during the treatment period.
4. Total dose of insulin and correction dose in each group.

Inclusion criteria:

• Men and women with type 2 diabetes that will need enteral nutrition with carbohydrate content.
• Glycemia >140mg/dL and < 400mg/dL at admission on the ward.
• Informed consent (patient or legally authorized representative)

Exclusion criteria:

• Hypersensibility to insulin glargine or glulisine, 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 hyperosmolar hyperglycaemic state or ketonuria.
• Subjects with conditions that are expected to need surgery or intensive care unit (ICU)admission based on discussions with the treatment team and attending physician.
• Pregnancy.
• Severe hepatic disease or active hepatitis.
• Cardiac failure class III or IV (Classification de la New York Heart Association:NYHA).
• Diagnosed advanced autonomic neuropathy.
• 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.