| Outcome Measures: |
Primary: Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability, Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse, 1 months|Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability, Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse, 2 months|Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline, Number of patients with any abnormal findings from physical examinations after baseline, including neurological assessments as an assessment of tolerability., Month 1, 2, 3, 6, 9, 15 and 30|Number of Patients With Clinically Significant Laboratory Findings, Number of patients with clinically significant laboratory findings, laboratory measurements as an assessment of the tolerability, Month 1, 2, 3, 6, 9, 15 and 30|GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period), GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000, 6 months|GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period), GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000, 15 months|GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period), GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000, 30 months|Number of Patients With an Infection Reported as Adverse Event Related to Study Treatment, Number of patients with an infection reported as Adverse Event related to study treatment (GAD-Alum and/or Etanercept),as an assessment of the tolerability, Month 1, 2, 3, 6, 9, 15 and 30 | Secondary: C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline, Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 6 months. MMTT=Mixed Meal Tolerance Test, Baseline and 6 months at 0, 30, 60, 90 and 120 minutes post-dose|C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline, Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 15 months, Baseline and 15 months at 0, 30, 60, 90 and 120 minutes post-dose|C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline, Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 30 months, Baseline and 30 months at 0, 30, 60, 90 and 120 minutes post-dose|Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L, Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 6 months, 6 months|Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L, Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 15 months, 15 months|Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L, Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 30 months, 30 months|Hemoglobin A1c (HbA1c), Change From Baseline, Hemoglobin A1c (HbA1c), change from baseline to 6 months, Baseline and 6 months|Hemoglobin A1c (HbA1c), Change From Baseline, Hemoglobin A1c (HbA1c), change from baseline to 15 months, Baseline and 15 months|Hemoglobin A1c (HbA1c), Change From Baseline, Hemoglobin A1c (HbA1c), change from baseline to 30 months, Baseline and 30 months|Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline, Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline, Baseline and 6 months|Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline, Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline, Baseline and 15 months|Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline, Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline, Baseline and 30 months|C-peptide: Stimulated, 90 Minute Value, Change From Baseline, C-peptide: Stimulated, 90 minute value, change from baseline to 6 months, Baseline and 6 months|C-peptide: Stimulated, 90 Minute Value, Change From Baseline, C-peptide: Stimulated, 90 minute value, change from baseline to 15 months, Baseline and 15 months|C-peptide: Stimulated, 90 Minute Value, Change From Baseline, C-peptide: Stimulated, 90 minute value, change from baseline to 30 months, Baseline and 30 months|C-peptide Fasting Concentration, Change From Baseline, C-peptide: Fasting concentration, change from baseline to 6 months, Baseline and 6 months|C-peptide Fasting Concentration, Change From Baseline, C-peptide: Fasting, concentration, change from baseline to 15 months, Baseline and 15 months|C-peptide Fasting Concentration, Change From Baseline, C-peptide: Fasting, concentration, change from baseline to 30 months, Baseline and 30 months|Spontaneous IL-17a Secretion, Spontaneous IL-17a secretion at baseline, 6 months, 9 months, 15 months and 30 months, Baseline, 6 months, 9 months, 15 months and 30 months|GAD65-induced IL-4 Secretion, GAD65-induced IL-4 secretion at baseline, 6 months, 9 months, 15 months, 30 months, Baseline, 6 months, 9 months, 15 months, 30 months|GAD65-induced IL-13 Secretion, GAD65-induced IL-13 secretion at baseline, 6 months, 9 months, 15 months, 30 months, Baseline, 6 months, 9 months, 15 months, 30 months|GAD65-induced IFN-gamma Secretion, GAD65-induced IFN-gamma secretion at baseline, 6 months, 9 months, 15 months, 30 months, Baseline, 6 months, 9 months, 15 months, 30 months|GAD65-induced TNF-alpha Secretion, GAD65-induced TNF-alpha secretion at baseline, 6 months, 9 months, 15 months, 30 months, Baseline, 6 months, 9 months, 15 months, 30 months|GAD65-induced GM-CSF Secretion, GAD65-induced GM-CSF secretion baseline, 6 months, 9 months, 15 months, 30 months, Baseline, 6 months, 9 months, 15 months, 30 months|GAD65-induced MIP-1b Secretion, GAD65-induced MIP-1b secretion at baseline, 6 months, 9 months, 15 months, 30 months, Baseline, 6 months, 9 months, 15 months, 30 months|GAD65-induced MCP-1 Secretion, GAD65-induced MCP-1 secretion at baseline, 6 months, 9 months, 15 months, 30 months, Baseline, 6 months, 9 months, 15 months, 30 months
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