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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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
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
Glycaemic parameters assessment
Time frame: During the period of 7 Days of treatment
Incidence of moderate and severe hyperglycemia
Time frame: During the period of 7 Days of treatment
Incidence of symptomatic, nocturnal and severe hypoglycemias
Time frame: During the period of 7 Days of treatment
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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 076-010
São Paulo, Brazil
Sanofi-Aventis Investigational Site Number 076-008
São Paulo, Brazil
Sanofi-Aventis Investigational Site Number 076-003
São Paulo, Brazil
Sanofi-Aventis Investigational Site Number 076-009
São Paulo, Brazil