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

Study Overview
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Brief Summary
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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: Incidence of moderate hyperglycemia (>140mg/dL) during the treatment period. Incidence of hypoglycemia (<60mg/dL and < 40mg/dL) during the treatment period. Incidence of severe hyperglycemia (>400mg/dL) during the treatment period. Total dose of insulin and correction dose in each group.

Official Title
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National, Phase IV, Multicentric, Open Label, Comparative Study to Evaluate the Efficacy and Safety of Insulin Glargine Plus Glulisine and Sliding Scale Plus Glulisine in Hospitalized Patients With Diabetes Metabolism Type II Under Enteral Nutrition.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: INSULIN GLARGINE
* Drug: INSULIN GLULISINE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Insulin Glargine + Insulin Glulisine | Drug: INSULIN GLARGINE<br>* Pharmaceutical form: Lantus® (100 U/ml) Route of administration: Subcutaneous injection with SoloStar® (3 ml) pen device. Dose regimen: Single daily dose of Insulin Glargine<br>Drug: INSULIN GLULISINE<br>* Pharmaceutical form: Apidra® (100 U/ml) Route of administration: Subcutaneous injection with SoloStar® (3 ml) pen device Dose regimen: Arm1: Every 6 hours Arm2: several daily dose according to sliding scale of Insulin Glargine<br>|
| Active Comparator: 2<br>Insulin Glulisine | Drug: INSULIN GLULISINE<br>* Pharmaceutical form: Apidra® (100 U/ml) Route of administration: Subcutaneous injection with SoloStar® (3 ml) pen device Dose regimen: Arm1: Every 6 hours Arm2: several daily dose according to sliding scale of Insulin Glargine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic parameters assessment |  | During the period of 7 Days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of moderate and severe hyperglycemia |  | During the period of 7 Days of treatment | 
| Incidence of symptomatic, nocturnal and severe hypoglycemias |  | During the period of 7 Days of treatment |