Clinical trial NCT01081938: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Glycaemic parameters assessment
timeFrame: During the period of 7 Days of treatment
Secondary outcomes:
measure: Incidence of moderate and severe hyperglycemia
timeFrame: During the period of 7 Days of treatment
measure: Incidence of symptomatic, nocturnal and severe hypoglycemias
timeFrame: During the period of 7 Days of treatment
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076-007
city: Curitiba
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076-011
city: Joinville
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076-005
city: Porto Alegre
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076-001
city: Porto Alegre
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076-004
city: São José do Rio Preto
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076-006
city: São Paulo
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076-010
city: São Paulo
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076-008
city: São Paulo
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076-003
city: São Paulo
country: Brazil
facility: Sanofi-Aventis Investigational Site Number 076-009
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: