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

NCT02294474

CompletedPhase 3

Sponsor: Sanofi

Conditions: Type 2 Diabetes Mellitus

Interventions: SAR342434, Humalog, insulin glargine HOE901

Countries: United States, Argentina, Chile, Colombia, Germany, Hungary, Italy, Romania

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

* 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.

Exclusion criteria:

* 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

Locations (103)

Foley, Alabama, United States
Muscle Shoals, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
El Cajon, California, United States
Fresno, California, United States
Greenbrae, California, United States
Huntington Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Northridge, California, United States
Palm Springs, California, United States
Santa Ana, California, United States
Temecula, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Boynton Beach, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Ocoee, Florida, United States
Palm Harbor, Florida, United States
Port Charlotte, Florida, United States
Lawrenceville, Georgia, United States
Stockbridge, Georgia, United States
Arlington Heights, Illinois, United States
Avon, Indiana, United States
Evansville, Indiana, United States
Des Moines, Iowa, United States
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