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

This study has been terminated.
(Recruitment challenges)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01081938
First received: March 4, 2010
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: INSULIN GLARGINE
Drug: INSULIN GLULISINE
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Glycaemic parameters assessment [ Time Frame: During the period of 7 Days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of moderate and severe hyperglycemia [ Time Frame: During the period of 7 Days of treatment ] [ Designated as safety issue: No ]
  • Incidence of symptomatic, nocturnal and severe hypoglycemias [ Time Frame: During the period of 7 Days of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: February 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081938

Locations
Brazil
Sanofi-Aventis Investigational Site Number 076-007
Belo Horizonte, Brazil, 30150-120
Sanofi-Aventis Investigational Site Number 076-011
Curitiba, Brazil, 80420-011
Sanofi-Aventis Investigational Site Number 076-005
Joinville, Brazil
Sanofi-Aventis Investigational Site Number 076-001
Porto Alegre, Brazil, 90035-001
Sanofi-Aventis Investigational Site Number 076-004
Porto Alegre, Brazil, 90035-003
Sanofi-Aventis Investigational Site Number 076-006
São José do Rio Preto, Brazil, 15090-000
Sanofi-Aventis Investigational Site Number 076-009
São Paulo, Brazil, 01323-900
Sanofi-Aventis Investigational Site Number 076-008
São Paulo, Brazil, 01308-050
Sanofi-Aventis Investigational Site Number 076-003
São Paulo, Brazil, 01323-020
Sanofi-Aventis Investigational Site Number 076-010
São Paulo, Brazil, 01232-010
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01081938     History of Changes
Other Study ID Numbers: LANTU_L_04572, U1111-1116-9777
Study First Received: March 4, 2010
Last Updated: March 26, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014