The effect of insulin analogues and human insulin on the incidence of severe hypoglycae-mia in hypoglycaemia prone type 1 diabetic patients

INTERVENTION: Trade Name: Levemir Pharmaceutical Form: Injection* INN or Proposed INN: insulin detemir Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100‐ Trade Name: NovoRapid Pharmaceutical Form: Injection* INN or Proposed INN: insulin aspart Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100‐ Trade Name: Insulatard Pharmaceutical Form: Injection* INN or Proposed INN: isophaninsulin human Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100‐ Trade Name: Actrapid Pharmaceutical Form: Injection* INN or Proposed INN: insulin human Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100‐ CONDITION: Type 1 diabetes ‐ E10.8 ; MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus PRIMARY OUTCOME: Main Objective: The primary objective is to evaluate the effects of insulin analogue and human insulin on incidence of severe hypoglycaemia in type 1 diabetic patients prone to hypoglycaemia.; Primary end point(s): The primary objective is to evaluate the effects of insulin analogue and human insulin on incidence of severe hypoglycaemia from 3 to 12 months of treatment in type 1 diabetic patients prone to hypoglycaemia Secondary Objective: Secondary endpoints are effect on incidence of symptomatic and asymptomatic docu‐mented hypoglycaemia. INCLUSION CRITERIA: Male or female aged 18 years Type 1 diabetes for 5 years or more Two or more episodes of severe hypoglycaemia during the preceding year Treated with human insulin or insulin analogues Willingness to do self monitoring of blood glucose (SMBG) Negative pregnancy test Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range