Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine

Completed · Phase 3

Conditions studied: Type 1 Diabetes Mellitus

In brief

Primary Objective: To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine. Secondary Objectives: To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study. To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension. To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants reaching target HbA1c (\<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose. To assess safety of SAR342434 and Humalog.

Key facts

Study ID

NCT02273180

Run by

Sanofi

People needed

507

Starts

2014-10-01

Expected to finish

2016-07-01

Last updated by the study team

2018-01-18

Who can join

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

You may qualify if…

• Participants with T1DM diagnosed for at least 12 months and had been treated with insulin glargine and Humalog or Novolog®/Novo Rapid® (at least 3 times daily before each meal) in the 6 months prior to the screening visit.
• Written informed consent.

You may not qualify if…

• At screening visit, age under legal age of adulthood.
• HbA1c <7.0% or >10% at screening.
• Diabetes other than T1DM.
• Status post pancreatectomy.
• Status post pancreas and/or islet cell transplantation.
• Pregnancy and lactation.
• Women of childbearing potential not protected by highly effective contraceptive method of birth control.
• Less than 1 year on continuous insulin treatment.
• Use of insulin pump in the last 6 months before screening visit.
• Use of glucose lowering treatments other than insulin including non-insulin injectable peptides in the last 6 months prior to screening visit.
• Use of insulin other than insulin glargine and Humalog or Novolog/Novo Rapid as part of a multiple injection regimen (3 to 4 injections per day) in the last 6 months before screening visit. Liprolog® is a European Union approved insulin lispro and is allowed in those countries where it is marketed.
• Hospitalization for diabetic ketoacidosis in the last 6 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.
• 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 840016 — Bell Gardens, California, United States
• Investigational Site Number 840048 — Chula Vista, California, United States
• Investigational Site Number 840046 — Concord, California, United States
• Investigational Site Number 840039 — Fresno, California, United States
• Investigational Site Number 840028 — La Jolla, California, United States
• Investigational Site Number 840022 — Ventura, California, United States
• Investigational Site Number 840003 — Denver, Colorado, United States
• Investigational Site Number 840037 — Denver, Colorado, United States
• Investigational Site Number 840005 — Bradenton, Florida, United States
• Investigational Site Number 840050 — Miami, Florida, United States
• Investigational Site Number 840042 — Miami, Florida, United States
• Investigational Site Number 840061 — Miami Lakes, Florida, United States
• Investigational Site Number 840057 — Miami Lakes, Florida, United States
• Investigational Site Number 840006 — New Port Richey, Florida, United States
• Investigational Site Number 840013 — North Miami Beach, Florida, United States
• Investigational Site Number 840031 — Port Charlotte, Florida, United States
• Investigational Site Number 840036 — Atlanta, Georgia, United States
• Investigational Site Number 840045 — Roswell, Georgia, United States
• Investigational Site Number 840020 — Idaho Falls, Idaho, United States
• Investigational Site Number 840019 — Chicago, Illinois, United States
• Investigational Site Number 840033 — Chicago, Illinois, United States
• Investigational Site Number 840012 — McHenry, Illinois, United States
• Investigational Site Number 840004 — Des Moines, Iowa, United States
• Investigational Site Number 840043 — Marrero, Louisiana, United States
• Investigational Site Number 840049 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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