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Sponsor: Sanofi
Conditions: Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus
Interventions: Insulin aspart, NovoLog/NovoRapid, Insulin glargine (HOE901)
Countries: United States, Finland, Germany, Hungary, Japan, Poland, Russia
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Little Rock, Arkansas, United States
- Concord, California, United States
- Escondido, California, United States
- Fresno, California, United States
- Greenbrae, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Pomona, California, United States
- Santa Barbara, California, United States
- Ventura, California, United States
- Aurora, Colorado, United States
- Englewood, Colorado, United States
- New Port Richey, Florida, United States
- Ocoee, Florida, United States
- Atlanta, Georgia, United States
- Columbus, Georgia, United States
- Roswell, Georgia, United States
- Arlington Heights, Illinois, United States
- Des Moines, Iowa, United States
- Metairie, Louisiana, United States
- Rockville, Maryland, United States
- Waltham, Massachusetts, United States
- Flint, Michigan, United States
- Omaha, Nebraska, United States
- Henderson, Nevada, United States
- New York, New York, United States
- Morehead City, North Carolina, United States
- Wilmington, North Carolina, United States
- Fargo, North Dakota, United States
- Bend, Oregon, United States
- + 52 more on CT.gov