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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Insulin, Short-Acting

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