Effect of GLP-1 on insulin dose, risk of hypoglycemia and gastric emptying in type 1 diabetes mellitus

INTERVENTION: Trade Name: Victoza Product Name: Victoza Product Code: H‐C‐1026‐00‐00 Pharmaceutical Form: Suspension for injection INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656‐20‐2 CONDITION: Type 1 diabetes ; MedDRA version: 12.0 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin‐dependent PRIMARY OUTCOME: Main Objective: To investigate whether treatment with GLP‐1 affects insulin dose and 24‐hours glucose profiles in patients with type 1 diabetes Primary end point(s): Insulin dose (IE/day) Secondary Objective: To investigate whether treatment with GLP‐1:; 1) affects the risk of hypoglycemia,; 2)affects the gastric emptying rate of hypoglycemia; 3)results in weight changes; 4)affects the glycemic control (HbA1c and fructosamin) INCLUSION CRITERIA: Type 1 diabetes, age 18‐55, BMI 18‐27, no known disease complications 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) no F.1.3.1 Number of subjects for this age range