An open-label extension multi-centre trial in adult subjects diagnosed with Type 1 diabetes mellitus exploring the effect of long-term Verapamil SR therapy on the preservation of beta-cell function.

Type 1 diabetes mellitus (T1D)

Change over time in C-peptide Area under the curve (C-pep AUC % change) in adults diagnosed with T1D receiving 360 mg oral Verapamil daily undergoing MMTT, measured at baseline (V-1) and 24 months of therapy (V8)

Changes over time in C-peptide Area under the curve (C-pep AUC % change) in adults diagnosed with T1D receiving 360 mg oral Verapamil Option 2 Fig. 2a Option 2 Fig. 2b EU CT Number:2024-515234-33-00 Page 15 of 59 Protocol Short Title Ver-A-Long Version Number: 2.0 Version Date: 12.06.2024 daily undergoing MMTT, measured at 6-, 12-, and 18 months of therapy (V5 to V7), Changes over time in blood glucose control as assessed by HbA1C in adults diagnosed with T1D receiving 360 mg oral Verapamil daily, measured at baseline (V-1) and 6-, 12-, 18- and 24 months of therapy (V5 to V8), Changes over time in insulin requirements as the total daily insulin dose (seven days average) in units per kg body weight (BW) in adults diagnosed with T1D receiving 360 mg oral Verapamil SR once daily, assessed at baseline (V-1) and 6-, 12- 18- and 24 months of therapy (V5 to V8), The number of treatment emergent severe hypoglycaemic episodes. Severe hypoglycaemia denotes severe cognitive impairment requiring external assistance for recovery according to the American Diabetes Association (ADA), The number of treatment emergent episodes of diabetic ketoacidosis (DKA)., Adverse events, vital signs variation, ECG, laboratory safety parameters, measured at baseline (V-1) and 6-, 12- 18- and 24 of therapy (V5 to V8)

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