Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc

Criteria

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.