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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
-
Belo Horizonte, Brésil, 30150-120
- Sanofi-Aventis Investigational Site Number 076-007
-
Curitiba, Brésil, 80420-011
- Sanofi-Aventis Investigational Site Number 076-011
-
Joinville, Brésil
- Sanofi-Aventis Investigational Site Number 076-005
-
Porto Alegre, Brésil, 90035-001
- Sanofi-Aventis Investigational Site Number 076-001
-
Porto Alegre, Brésil, 90035-003
- Sanofi-Aventis Investigational Site Number 076-004
-
São José do Rio Preto, Brésil, 15090-000
- Sanofi-Aventis Investigational Site Number 076-006
-
São Paulo, Brésil, 01232-010
- Sanofi-Aventis Investigational Site Number 076-010
-
São Paulo, Brésil, 01308-050
- Sanofi-Aventis Investigational Site Number 076-008
-
São Paulo, Brésil, 01323-020
- Sanofi-Aventis Investigational Site Number 076-003
-
São Paulo, Brésil, 01323-900
- Sanofi-Aventis Investigational Site Number 076-009
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 1
Insulin Glargine + Insulin Glulisine
|
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 |
|
Comparateur actif: 2
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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Glycaemic parameters assessment
Délai: During the period of 7 Days of treatment
|
During the period of 7 Days of treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Incidence of moderate and severe hyperglycemia
Délai: During the period of 7 Days of treatment
|
During the period of 7 Days of treatment
|
|
Incidence of symptomatic, nocturnal and severe hypoglycemias
Délai: During the period of 7 Days of treatment
|
During the period of 7 Days of treatment
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LANTU_L_04572
- U1111-1116-9777 (Autre identifiant: UTN)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .