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

This study has been terminated.
(Recruitment challenges)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081938
First Posted: March 5, 2010
Last Update Posted: March 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
March 4, 2010
March 5, 2010
March 27, 2012
February 2010
February 2011   (Final data collection date for primary outcome measure)
Glycaemic parameters assessment [ Time Frame: During the period of 7 Days of treatment ]
Same as current
Complete list of historical versions of study NCT01081938 on ClinicalTrials.gov Archive Site
  • Incidence of moderate and severe hyperglycemia [ Time Frame: During the period of 7 Days of treatment ]
  • Incidence of symptomatic, nocturnal and severe hypoglycemias [ Time Frame: During the period of 7 Days of treatment ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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

  • Experimental: 1
    Insulin Glargine + Insulin Glulisine
    Interventions:
    • Drug: INSULIN GLARGINE
    • Drug: INSULIN GLULISINE
  • Active Comparator: 2
    Insulin Glulisine
    Intervention: Drug: INSULIN GLULISINE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
February 2011
February 2011   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01081938
LANTU_L_04572
U1111-1116-9777 ( Other Identifier: UTN )
No
Not Provided
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP