Lantus: Solostar Half unit syringe; whole unit syringe for Lantus doses > 30 units Duration of 6 months (comparative main 16 (2 x 8 weeks) treatment study period) 6 months comparative extension period* Number of patients HOE901-U300; 274 HOE901-U300; 30 randomised Lantus; 275 Lantus; 29 *Extension period ongoing at the time of the cut off; results not included in the dossier OAD = oral anti hyperglycaemic drugs; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus; CGM = continuous glucose monitoring; NA = not applicable Table 5: Characteristics of Pivotal Studies EFC11628, EFC11629, EFC12347 Studies in T2DM EFC11628 Phase EFC11629 Phase EFC12347 III III Phase III Population T2DM on basal T2DM on basal T1DM on insulin in insulin in insulin in combination with combination with combination with mealtime insulin OAD mealtime insulin analogue analogue Region North America, North America, North America, South America, South America, South America, Europe, South Africa Europe, South Africa Europe, Japan Comparator Lantus Lantus Lantus Randomisation 1:1 1:1 1:1 Main objectives Efficacy and safety Efficacy and safety Efficacy and safety Route Once daily SC Once SC Once daily SC injection injection injection Injection device HOE901-U300: HOE901-U300: HOE901-U300: modified Solostar modified Solostar modified Tactipen Lantus: Solostar Lantus: Solostar Lantus: Solostar Duration of 6 months (main 6 months (main 6 months (main treatment period) study period) study period) 6 months 6 months 6 months comparative comparative comparative extension period* extension period* extension period*
Lantus: Solostar Half unit syringe; whole unit syringe for Lantus doses > 30 units Duration of treatment 6 months (comparative main study period) 6 months comparative extension period* 16 (2 x 8 weeks) Number of patients randomised HOE901-U300; 274 Lantus; 275 HOE901-U300; 30 Lantus; 29 *Extension period ongoing at the time of the cut off; results not included in the dossier OAD = oral anti hyperglycaemic drugs; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus; CGM = continuous glucose monitoring; NA = not applicable Table 5: Characteristics of Pivotal Studies EFC11628, EFC11629, EFC12347 Studies in T2DM EFC11628 Phase III EFC11629 Phase III EFC12347 Phase III Population T2DM on basal insulin in combination with mealtime insulin analogue T2DM on basal insulin in combination with OAD T1DM on insulin in combination with mealtime insulin analogue Region North America, South America, Europe, South Africa North America, South America, Europe, South Africa North America, South America, Europe, Japan Comparator Lantus Lantus Lantus Randomisation 1:1 1:1 1:1 Main objectives Efficacy and safety Efficacy and safety Efficacy and safety Route Injection device Once daily SC injection HOE901-U300: modified Solostar Lantus: Solostar Once SC injection HOE901-U300: modified Solostar Lantus: Solostar Once daily SC injection HOE901-U300: modified Tactipen Lantus: Solostar Duration of treatment 6 months (main period) 6 months comparative extension period* 6 months (main study period) 6 months comparative extension period* 6 months (main study period) 6 months comparative extension period*