Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

Primary Objective: To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) 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. To assess the efficacy of SAR342434 and Humalog on: proportion of participants reaching target HbA1c \<7.0% and \<=6.5%, fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin dose. To assess safety of SAR342434 and Humalog.

Key facts

Study ID

NCT02294474

Run by

Sanofi

People needed

505

Starts

2015-01-01

Expected to finish

2016-02-01

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 T2DM diagnosed for at least 12 months and treated with insulin glargine and Humalog®/Liprolog® or NovoLog®/NovoRapid® (at least 3 times daily, before each meal) in the 6 months prior to the screening visit.
• Signed written informed consent.

You may not qualify if…

• At screening visit, age under legal age of adulthood.
• HbA1c <6.5% or >10.0% at screening.
• Diabetes other than T2DM.
• Pregnancy and lactation.
• Women of childbearing potential not protected by highly effective contraceptive method of birth control.
• Use of insulin pump in the 6 months before screening visit.
• Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6 months prior to screening visit. Liprolog® is an European Union (EU) approved insulin lispro and is allowed in those countries where it is marketed.
• Use of Humalog/Liprolog or Novolog/NovoRapid less than 3 times daily, before each meal.
• Use of non-injectable peptides (eg, Glucagon-like peptide-1 (GLP-1) receptor-agonists or other peptides) in the 6 months prior to screening visit.
• Body mass index (BMI) >=40kg/m² at screening visit.
• 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 840237 — Muscle Shoals, Alabama, United States
• Investigational Site Number 840245 — Chandler, Arizona, United States
• Investigational Site Number 840219 — Phoenix, Arizona, United States
• Investigational Site Number 840227 — Phoenix, Arizona, United States
• Investigational Site Number 840212 — Little Rock, Arkansas, United States
• Investigational Site Number 840241 — El Cajon, California, United States
• Investigational Site Number 840238 — Fresno, California, United States
• Investigational Site Number 840229 — Greenbrae, California, United States
• Investigational Site Number 840231 — Huntington Beach, California, United States
• Investigational Site Number 840247 — Long Beach, California, United States
• Investigational Site Number 840234 — Los Angeles, California, United States
• Investigational Site Number 840235 — Northridge, California, United States
• Investigational Site Number 840251 — Palm Springs, California, United States
• Investigational Site Number 840249 — Santa Ana, California, United States
• Investigational Site Number 840223 — Temecula, California, United States
• Investigational Site Number 840259 — Tustin, California, United States
• Investigational Site Number 840240 — Walnut Creek, California, United States
• Investigational Site Number 840214 — Boynton Beach, Florida, United States
• Investigational Site Number 840246 — Miami, Florida, United States
• Investigational Site Number 840226 — New Port Richey, Florida, United States
• Investigational Site Number 840205 — Ocoee, Florida, United States
• Investigational Site Number 840206 — Palm Harbor, Florida, United States
• Investigational Site Number 840242 — Port Charlotte, Florida, United States
• Investigational Site Number 840253 — Lawrenceville, Georgia, United States
• Investigational Site Number 840217 — Foley, Alabama, United States

Full record on ClinicalTrials.gov

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