NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT03211858

CompletedPhase 3

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (82)
  • 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