| Outcome Measures: |
Primary: Number of Subjects With Injection Site Reactions Month 1, Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching), Month 1|Number of Subjects With Injection Site Reactions Month 2, Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching), Month 2|Number of Subjects With Injection Site Reactions Month 3, Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching), Month 3|Number of Subjects With Injection Site Reactions Month 32, Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching), Month 32, extension period | Secondary: Mean Change in C-peptide AUC (Area Under the Curve) (Mean 120min) Value, Month 15, Change from baseline to month 15 in C-peptide AUC (Area Under the Curve) (mean 120min) value AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L\*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration, Baseline to month 15 at 0, 30, 60, 90, 120 minutes post-dose|Mean Change in C-peptide AUC(Mean 120min) Value, Month 30, Change from baseline to month 30 in C-peptide AUC(mean 120min) value AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L\*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration, Baseline to month 30 at 0, 30, 60, 90, 120 minutes post-dose|Mean Change in C-peptide AUC(Mean 120min) Value, Month 43, Change from baseline to month 43 in C-peptide AUC(mean 120min) value AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L\*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration, Baseline to month 43, extension period at 0, 30, 60, 90, 120 minutes post-dose|Mean Change in C-peptide 90-minute Value, Month 15, Change from baseline to month 15 in C-peptide 90-minute value, Baseline to month 15|Mean Change in C-peptide 90-minute Value, Month 30, Change from baseline to month 30 in C-peptide 90-minute value, Baseline to month 30|Mean Change in C-peptide 90-minute Value, Month 43, Change from baseline to month 43 in C-peptide 90-minute value, Baseline to month 43, extension period|Mean Change in Fasting C-peptide Value, Month 15, Change from baseline to month 15 in fasting C-peptide value, Baseline to month 15|Mean Change in Fasting C-peptide Value, Month 30, Change from baseline to month 30 in fasting C-peptide value, Baseline to month 30|Mean Change in Fasting C-peptide Value, Month 43, Change from baseline to month 43 in fasting C-peptide value, Baseline to month 43, extension period|Mean Change in HbA1c, Month 15, Change from baseline to month 15 in HbA1c, Baseline to month 15|Mean Change in HbA1c, Month 30, Change from baseline to month 30 in HbA1c, Baseline to month 30|Mean Change in HbA1c, Month 43, Change from baseline to month 43 in HbA1c, Baseline to month 43, extension period|External Insulin Dose, Baseline, External insulin dose at baseline, Baseline|External Insulin Dose, Month 15, External insulin dose at month 15, Month 15|External Insulin Dose, Month 30, External insulin dose at month 30, Month 30|External Insulin Dose, Month 43, External insulin dose at month 43, Month 43, extension period|Mean IDAA1c Values, Baseline, Insulin dose-adjusted HbA1c (IDAA1c), Baseline|Mean IDAA1c Values, Month 15, Insulin dose-adjusted HbA1c (IDAA1c), Month 15|Mean IDAA1c Values, Month 30, Insulin dose-adjusted HbA1c (IDAA1c), Month 30|Mean IDAA1c Values, Month 43, Insulin dose-adjusted HbA1c (IDAA1c), Month 43, extension period
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