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

NCT ID: NCT01081938

Last Updated: 2012-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-02-28

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Insulin Glargine + Insulin Glulisine

Group Type: EXPERIMENTAL

INSULIN GLARGINE

Intervention Type: DRUG

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

INSULIN GLULISINE

Intervention Type: DRUG

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

2

Insulin Glulisine

Group Type: ACTIVE_COMPARATOR

INSULIN GLULISINE

Intervention Type: DRUG

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

Interventions

INSULIN GLARGINE

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

Intervention Type: DRUG

INSULIN GLULISINE

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Investigational Site Number 076-007

Belo Horizonte, , Brazil

Sanofi-Aventis Investigational Site Number 076-011

Curitiba, , Brazil

Sanofi-Aventis Investigational Site Number 076-005

Joinville, , Brazil

Sanofi-Aventis Investigational Site Number 076-001

Porto Alegre, , Brazil

Sanofi-Aventis Investigational Site Number 076-004

Porto Alegre, , Brazil

Sanofi-Aventis Investigational Site Number 076-006

São José do Rio Preto, , Brazil

Sanofi-Aventis Investigational Site Number 076-010

São Paulo, , Brazil

Sanofi-Aventis Investigational Site Number 076-008

São Paulo, , Brazil

Sanofi-Aventis Investigational Site Number 076-003

São Paulo, , Brazil

Sanofi-Aventis Investigational Site Number 076-009

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

U1111-1116-9777

Identifier Type: OTHER

Identifier Source: secondary_id

LANTU_L_04572

Identifier Type: -

Identifier Source: org_study_id