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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
INSULIN GLARGINE
INSULIN GLULISINE
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sanofi-Aventis Investigational Site Number 076-007
  • Sanofi-Aventis Investigational Site Number 076-011
  • Sanofi-Aventis Investigational Site Number 076-005
  • Sanofi-Aventis Investigational Site Number 076-001
  • Sanofi-Aventis Investigational Site Number 076-004
  • Sanofi-Aventis Investigational Site Number 076-006
  • Sanofi-Aventis Investigational Site Number 076-010
  • Sanofi-Aventis Investigational Site Number 076-008
  • Sanofi-Aventis Investigational Site Number 076-003
  • Sanofi-Aventis Investigational Site Number 076-009

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Insulin Glargine + Insulin Glulisine

Insulin Glulisine

Outcomes

Primary Outcome Measures

Glycaemic parameters assessment

Secondary Outcome Measures

Incidence of moderate and severe hyperglycemia
Incidence of symptomatic, nocturnal and severe hypoglycemias

Full Information

First Posted
March 4, 2010
Last Updated
March 26, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01081938
Brief Title
Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Recruitment challenges
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Insulin Glargine + Insulin Glulisine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Insulin Glulisine
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE
Intervention Description
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
Intervention Name(s)
INSULIN GLULISINE
Intervention Description
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
Primary Outcome Measure Information:
Title
Glycaemic parameters assessment
Time Frame
During the period of 7 Days of treatment
Secondary Outcome Measure Information:
Title
Incidence of moderate and severe hyperglycemia
Time Frame
During the period of 7 Days of treatment
Title
Incidence of symptomatic, nocturnal and severe hypoglycemias
Time Frame
During the period of 7 Days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Investigational Site Number 076-007
City
Belo Horizonte
ZIP/Postal Code
30150-120
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076-011
City
Curitiba
ZIP/Postal Code
80420-011
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076-005
City
Joinville
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076-001
City
Porto Alegre
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076-004
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076-006
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076-010
City
São Paulo
ZIP/Postal Code
01232-010
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076-008
City
São Paulo
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076-003
City
São Paulo
ZIP/Postal Code
01323-020
Country
Brazil
Facility Name
Sanofi-Aventis Investigational Site Number 076-009
City
São Paulo
ZIP/Postal Code
01323-900
Country
Brazil

12. IPD Sharing Statement

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

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