New insulin strength could simplify diabetes care

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria : * Male or female patients, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year * Total insulin dose of \<1.0 U/kg/day * Fasting serum C-peptide \<0.30 nmol/L at screening * Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%) at screening * Stable insulin regimen for at least 2 months prior to study (day of insulin regimen switch, with respect to safety of the patient and scientific integrity of the study). * Patients with anti-insulin antibody titer at screening ≤ 30.0 kU/L * Body weight between 50.0 kg and 100.0 kg, inclusive, il male , and between 40.0 and 90.0 kg, inclusive, if female, Body Mass Index between 18 and 30.0 kg/m², inclusive Exclusion criteria: * Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness or any history or presence of HIT-type II (heparin induced thrombocytopenia Type II) * More than 1 episode of severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. * Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, more than twice a month). * Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position. * Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. * Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol * If female, pregnancy (defined as positive β-HCG blood test), breast-feeding The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.