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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Belo Horizonte, Brazil, 30150-120
    • Sanofi-Aventis Investigational Site Number 076-007
  • Curitiba, Brazil, 80420-011
    • Sanofi-Aventis Investigational Site Number 076-011
  • Joinville, Brazil
    • Sanofi-Aventis Investigational Site Number 076-005
  • Porto Alegre, Brazil, 90035-001
    • Sanofi-Aventis Investigational Site Number 076-001
  • Porto Alegre, Brazil, 90035-003
    • Sanofi-Aventis Investigational Site Number 076-004
  • São José do Rio Preto, Brazil, 15090-000
    • Sanofi-Aventis Investigational Site Number 076-006
  • São Paulo, Brazil, 01232-010
    • Sanofi-Aventis Investigational Site Number 076-010
  • São Paulo, Brazil, 01308-050
    • Sanofi-Aventis Investigational Site Number 076-008
  • São Paulo, Brazil, 01323-020
    • Sanofi-Aventis Investigational Site Number 076-003
  • São Paulo, Brazil, 01323-900
    • Sanofi-Aventis Investigational Site Number 076-009

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Insulin Glargine + Insulin Glulisine	Drug: 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; 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
Active Comparator: 2; Insulin Glulisine	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: March 4, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimate): March 5, 2010

Study Record Updates

• Last Update Posted (Estimate): March 27, 2012
• Last Update Submitted That Met QC Criteria: March 26, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
• Other Study ID Numbers: LANTU_L_04572; U1111-1116-9777 (Other Identifier: UTN)