Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine
Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine
Primary Objective:

 To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin
 A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes
 mellitus (T1DM or T2DM) also using Lantus®.

 Secondary Objectives:

 -  To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of
 positive/negative status and anti-insulin antibody (AIA) titers during the course of the
 study.

 -  To assess the relationship of AIAs with efficacy and safety.

 -  To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of
 participants reaching HbA1c lesser than (<) 7.0% and change in HbA1c, fasting plasma
 glucose (FPG), and self-measured plasma glucose (SMPG) profiles from baseline to Week 26
 and Week 52 (only Week 52 for HbA1c).

 -  To assess safety of SAR341402 and NovoLog/NovoRapid.
The study consisted of a 2-week screening period, a 26-week treatment period, a 26-week
 comparative safety extension period, and a 1-day follow-up period. The maximum study duration
 was 54 weeks per participant and a 1 day safety follow-up.
Inclusion criteria :

 -  Participants with T1DM or T2DM (T2DM US only) diagnosed for at least 12 months, who
 have been treated with a multiple daily injection regimen with

 -  NovoLog/NovoRapid or insulin lispro (100 U/mL) in the last 6 months prior to screening
 visit AND

 -  insulin glargine (100 U/mL) in the last 6 months prior to screening visit OR insulin
 detemir (Levemir®) in the last 12 months prior to screening visit.

 Exclusion criteria:

 -  At screening visit, age under legal age of adulthood.

 -  HbA1c <7.0% or greater than (>) 10% at screening.

 -  Less than 1 year on continuous insulin treatment.

 -  Use of insulin pump in the last 3 months before screening visit.

 -  Participants with incomplete baseline 7-point SMPG profile, defined as participants
 who do not have 7-point profiles with at least 5 points on at least 2 days in the week
 before randomization Visit 3.

 -  Participants with T1DM: Use of glucose lowering agents other than insulin including
 use of non-insulin injectable peptides in the last 3 months prior to screening.

 -  Participants with T2DM:

 -  Use of glucagon-like peptide-1 (GLP-1) receptor agonists in the last 3 months
 before screening visit.

 -  Use of oral antidiabetic drugs (OADs) not on stable dose in the last 3 months
 before screening visit (sulfonylureas was discontinued at baseline).

 -  At screening visit, body mass index (BMI) greater than or equal to (>=) 35 kilogram
 per meter square (kg/m^2) in participants with T1DM and >=40 kg/m^2 in participants
 with T2DM.

 -  Use of insulin other than:

 -  insulin glargine 100 U/mL and NovoLog/NovoRapid or insulin lispro 100 U/mL as
 part of a multiple injection regimen in the last 6 months before screening visit,
 OR

 -  insulin detemir 100 U/mL in the 12 months before screening visit and
 NovoLog/NovoRapid or insulin lispro 100 U/mL in the last 6 months before
 screening visit as part of a multiple injection regimen.

 -  Status post pancreatectomy.

 -  Status post pancreas and/or islet cell transplantation.

 -  Hospitalization for recurrent diabetic ketoacidosis in the last 3 months before
 screening visit.

 -  History of severe hypoglycemia requiring Emergency Room admission or hospitalization
 in the last 3 months before screening visit.

 -  Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic
 retinopathy or macular edema likely to require treatment (eg, laser, surgical
 treatment or injectable drugs) during the study period.

 -  Pregnant or breastfeeding women.

 -  Women of childbearing potential not protected by highly effective method(s) of birth
 control.

 The above information is not intended to contain all considerations relevant to a
 participant's potential participation in a clinical trial.