Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
To demonstrate the superiority of a strategy with insulin glargine in comparison with a
strategy including the premixed insulin in term of percentage of patients reaching HbA1c
(glycosylated hemoglobin) below 7% at the end of treatment and who do not experience
documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1
mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle
management and oral agents.
Secondary Objectives:
To assess the effect of insulin glargine in comparison with premixed insulin on :
- Evolution of HbA1c level during the treatment period Percentage of patients who reach
the target of HbA1c < 7 % and who do not experience documented symptomatic hypoglycemia
confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L)
- Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience
documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L)
>Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience
documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L)
>Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles
- Evolution of weight
- Hypoglycemia occurrence
- Dose of insulins
- Evolution of liver function
- Overall safety