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

Sanofi

Status and phase: Terminated; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE

Study type: Interventional

Funder types: Industry

Identifiers

NCT01081938

LANTU_L_04572

U1111-1116-9777 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

1

Experimental group

Description:

Insulin Glargine + Insulin Glulisine

Treatment:

Drug: INSULIN GLULISINE

Drug: INSULIN GLARGINE

2

Active Comparator group

Description:

Insulin Glulisine

Treatment:

Drug: INSULIN GLULISINE