A Single-Center, Double Blind Study Evaluating the Bioequivalence of the Pharmacokinetic and Pharmacodynamic Properties of Different Formulations of VIAject™ in Subjects with Type 1 Diabetes Mellitus

INTERVENTION: Product Name: VIAjectTM Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: INSULIN HUMAN CAS Number: 11061680 Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 25 IU/ml‐ Product Name: VIAjectTM Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: INSULIN HUMAN CAS Number: 11061680 Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100 IU/ml‐ Product Name: VIAject A TM Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN HUMAN CAS Number: 11061680 Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 25 IU/ml‐ Product Name: VIAject A TM Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN HUMAN CAS Number: 11061680 Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100 IU/ml‐ CONDITION: Type 1 Diabetes Mellitus ; MedDRA version: 9.1 Level: LLT Classification code 10045238 Term: Type I diabetes mellitus without mention of complication PRIMARY OUTCOME: Main Objective: The primary objective of this study is to test for bioequivalence between VIAject™ 25 and three other formulations of VIAject™ (VIAject™ 100, VIAject A™ 25 and VIAject A™ 100) Primary end point(s): Test for bioequivalence between VIAject™ 25 and three other formulations of VIAject™ (VIAject™ 100, VIAject A™ 25 and VIAject A™ 100). Secondary Objective: The secondary objectives of this study are to compare the pharmacokinetic characteristics of VIAjectTM 25 with those of three other formulations of VIAjectTM (VIAject™ 100, VIAject A™ 25 and VIAject A™ 100) and to compare the pharmacodynamic characteristics of VIAjectTM 25 with those of three other formulations of VIAjectTM (VIAject™ 100, VIAject A™ 25 and VIAject A™ 100).; Furthermore the safety and tolerability of VIAject™ 25, VIAject™ 100, VIAject A™ 25 and VIAject A™ 100 will be evaluated.; To evaluate the safety profile of the formulations VIAject™ 100 compared to VIAject™ 25, VIAject A™ 25 compared to VIAject™ 25 and VIAject A™ 100 compared to VIAject™ 25 as assessed by ECG, standard safety laboratory parameters and incidence of adverse events after subcutaneous injection; INCLUSION CRITERIA: 1. Age: =19 to = 65 years 2. Body Mass Index: = 18 ‐ = 28 kg/m2 3. Diagnosed with Type 1 Diabetes Mellitus for at least 1 year 4. Insulin antibody less than or equal to 10 uU/ml at screening 5. Non‐smoker, defined as no nicotine consumption for at least one year. 6. Signed and dated informed consent obtained before any trial‐related activities. (Trial‐related activities are any procedure that would not have been performed during normal management of the subject.). 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