Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients

Exclusion Criteria

• •Hemoglobin A1c (HbA1c) ≥8.5% at screening.
• •Diabetes other than T1DM.
• •History of infection at the infusion site within 3 months prior to the screening visit (Visit 1).
• •Use of oral glucose-lowering agents or any injectable glucose-lowering agents other than insulin during the 3 months before screening visit.
• •Hospitalization for recurrent diabetic ketoacidosis (DKA) in the last 6 months before screening visit.
• •History of severe hypoglycemia requiring emergency room admission or hospitalization in the last 6 months before screening visit.
• •Hypoglycemic unawareness as judged by the Investigator in the last 6 months before the screening visit.
• •Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening that in the judgment of the investigator or any sub investigator would preclude safe completion of the study.
• •Known history of illegal drug or alcohol abuse within 6 months prior to the time of screening.
• •Use of investigational drug(s) within 3 months or 5 half-lives, whichever is longer, prior to the screening visit.
• •Patients who had previously received SAR341402 in any other clinical trial.
• •Any contraindication to the use of NovoLog® as defined in the national product labels; history of hypersensitivity to NovoLog® or to any of the excipients.
• •Pregnancy and lactation.
• •If female, pregnancy \[defined as positive β-HCG (Human Chorionic Gonadotropin) in blood or in urine\], breast-feeding.
• •Patient is an employee or relative of an employee of the sponsor.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.