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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
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Belo Horizonte, Brasil, 30150-120
- Sanofi-Aventis Investigational Site Number 076-007
-
Curitiba, Brasil, 80420-011
- Sanofi-Aventis Investigational Site Number 076-011
-
Joinville, Brasil
- Sanofi-Aventis Investigational Site Number 076-005
-
Porto Alegre, Brasil, 90035-001
- Sanofi-Aventis Investigational Site Number 076-001
-
Porto Alegre, Brasil, 90035-003
- Sanofi-Aventis Investigational Site Number 076-004
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São José do Rio Preto, Brasil, 15090-000
- Sanofi-Aventis Investigational Site Number 076-006
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São Paulo, Brasil, 01232-010
- Sanofi-Aventis Investigational Site Number 076-010
-
São Paulo, Brasil, 01308-050
- Sanofi-Aventis Investigational Site Number 076-008
-
São Paulo, Brasil, 01323-020
- Sanofi-Aventis Investigational Site Number 076-003
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São Paulo, Brasil, 01323-900
- Sanofi-Aventis Investigational Site Number 076-009
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
|
Aktiv komparator: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Glycaemic parameters assessment
Tidsramme: During the period of 7 Days of treatment
|
During the period of 7 Days of treatment
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of moderate and severe hyperglycemia
Tidsramme: During the period of 7 Days of treatment
|
During the period of 7 Days of treatment
|
|
Incidence of symptomatic, nocturnal and severe hypoglycemias
Tidsramme: During the period of 7 Days of treatment
|
During the period of 7 Days of treatment
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LANTU_L_04572
- U1111-1116-9777 (Annen identifikator: UTN)
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