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:
- 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Belo Horizonte, Brazilië, 30150-120
- Sanofi-Aventis Investigational Site Number 076-007
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Curitiba, Brazilië, 80420-011
- Sanofi-Aventis Investigational Site Number 076-011
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Joinville, Brazilië
- Sanofi-Aventis Investigational Site Number 076-005
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Porto Alegre, Brazilië, 90035-001
- Sanofi-Aventis Investigational Site Number 076-001
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Porto Alegre, Brazilië, 90035-003
- Sanofi-Aventis Investigational Site Number 076-004
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São José do Rio Preto, Brazilië, 15090-000
- Sanofi-Aventis Investigational Site Number 076-006
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São Paulo, Brazilië, 01232-010
- Sanofi-Aventis Investigational Site Number 076-010
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São Paulo, Brazilië, 01308-050
- Sanofi-Aventis Investigational Site Number 076-008
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São Paulo, Brazilië, 01323-020
- Sanofi-Aventis Investigational Site Number 076-003
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São Paulo, Brazilië, 01323-900
- Sanofi-Aventis Investigational Site Number 076-009
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 1
Insulin Glargine + Insulin Glulisine
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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 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 |
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Actieve vergelijker: 2
Insulin Glulisine
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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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Glycaemic parameters assessment
Tijdsspanne: During the period of 7 Days of treatment
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During the period of 7 Days of treatment
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Incidence of moderate and severe hyperglycemia
Tijdsspanne: During the period of 7 Days of treatment
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During the period of 7 Days of treatment
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Incidence of symptomatic, nocturnal and severe hypoglycemias
Tijdsspanne: During the period of 7 Days of treatment
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During the period of 7 Days of treatment
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- LANTU_L_04572
- U1111-1116-9777 (Andere identificatie: UTN)
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