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

Completed · Phase 3

Conditions studied: Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID: NCT03211858
Run by: Sanofi
People needed: 597
Starts: 2017-08-02
Expected to finish: 2019-01-12
Last updated by the study team: 2022-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Investigational Site Number 8400012 — Concord, California, United States
Investigational Site Number 8400002 — Escondido, California, United States
Investigational Site Number 8400030 — Fresno, California, United States
Investigational Site Number 8400004 — Greenbrae, California, United States
Investigational Site Number 8400014 — La Jolla, California, United States
Investigational Site Number 8400043 — Los Angeles, California, United States
Investigational Site Number 8400036 — Pomona, California, United States
Investigational Site Number 8400011 — Santa Barbara, California, United States
Investigational Site Number 8400013 — Ventura, California, United States
Investigational Site Number 8400037 — Aurora, Colorado, United States
Investigational Site Number 8400018 — Englewood, Colorado, United States
Investigational Site Number 8400031 — New Port Richey, Florida, United States
Investigational Site Number 8400027 — Ocoee, Florida, United States
Investigational Site Number 8400007 — Atlanta, Georgia, United States
Investigational Site Number 8400022 — Columbus, Georgia, United States
Investigational Site Number 8400032 — Roswell, Georgia, United States
Investigational Site Number 8400038 — Arlington Heights, Illinois, United States
Investigational Site Number 8400005 — Des Moines, Iowa, United States
Investigational Site Number 8400041 — Metairie, Louisiana, United States
Investigational Site Number 8400015 — Rockville, Maryland, United States
Investigational Site Number 8400042 — Waltham, Massachusetts, United States
Investigational Site Number 8400019 — Flint, Michigan, United States
Investigational Site Number 8400003 — Omaha, Nebraska, United States
Investigational Site Number 8400024 — Henderson, Nevada, United States
Investigational Site Number 8400040 — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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