Type 1 Diabetes Mellitus Clinical Trial
Official title:
Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)
Primary Objective: - To assess the safety of SAR341402 and NovoLog® when used in external insulin pumps in terms of the number of patients with infusion set occlusions. Secondary Objectives: - To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of unexplained hyperglycemia. - To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of: - Intervals for infusion set changes. - Number of patients with insulin pump for "non-delivery" alarm. - Patient observation of infusion set occlusion. - Adverse events and serious adverse events. - Number of patients with hypoglycemic events [according to ADA (American Diabetes Association) Workgroup on hypoglycemia].
The study duration for each patient will be approximately 10 weeks, including a 2-week screening period, 2 treatment periods of 4 weeks each, and 1-day post-treatment safety follow-up period. ;
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