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

Launched by SANOFI · Jul 6, 2017

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.