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

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01081938
• Other study ID #: LANTU_L_04572
• Secondary ID: U1111-1116-9777
• Status: Terminated
• Phase: Phase 4
• First received: March 4, 2010
• Last updated: March 26, 2012
• Start date: February 2010
• Est. completion date: February 2011

Study information

• Verified date: March 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Investigational Site Number 076-007	Belo Horizonte
Brazil	Sanofi-Aventis Investigational Site Number 076-011	Curitiba
Brazil	Sanofi-Aventis Investigational Site Number 076-005	Joinville
Brazil	Sanofi-Aventis Investigational Site Number 076-001	Porto Alegre
Brazil	Sanofi-Aventis Investigational Site Number 076-004	Porto Alegre
Brazil	Sanofi-Aventis Investigational Site Number 076-006	São José do Rio Preto
Brazil	Sanofi-Aventis Investigational Site Number 076-003	São Paulo
Brazil	Sanofi-Aventis Investigational Site Number 076-008	São Paulo
Brazil	Sanofi-Aventis Investigational Site Number 076-009	São Paulo
Brazil	Sanofi-Aventis Investigational Site Number 076-010	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic parameters assessment		During the period of 7 Days of treatment	No
Secondary	Incidence of moderate and severe hyperglycemia		During the period of 7 Days of treatment	No
Secondary	Incidence of symptomatic, nocturnal and severe hypoglycemias		During the period of 7 Days of treatment	Yes