Extrait

Initiation Phase The primary objective of the 6-month initiation phase of this study of patients with type 2 diabetes with inadequate glycemic control is to test the hypothesis that addition of twicedaily insulin lispro LM to existing OAM therapy as compared to the addition of once daily insulin glargine will result in greater reduction in endpoint HbA1c adjusted for baseline HbA1c. Maintenance phase The primary objective of the two-year maintenance phase of this study is to test the hypothesis that the addition of twice-daily insulin lispro LM to existing OAMs results in a longer durability of glycemic control than the addition of once daily insulin glargine such that more subjects will remain at HbA1c goal (HbA1c at ≤7.0% or >7.0% but with an increase of less than 0.4% from the last HbA1c ≤7.0%). Durability is defined as the duration of time for maintaining the HbA1c at goal.

Critère d'inclusion

• type II diabetes mellitus

Liens

• euctr
• ictrp
• ictrp
• euctr
• ictrp
• euctr