Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine (SORELLA2)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: insulin glargine HOE901; Drug: Humalog; Drug: SAR342434

Study type: Interventional

Funder types: Industry

Identifiers

NCT02294474

U1111-1156-4296

EFC13403

2014-002844-42 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

The study will consist of a: up to 2 weeks screening period, 26-week treatment period, and 1-day follow-up period.

The maximum study duration will then be 28 weeks per participant and a 1-day safety follow-up.

Enrollment: 505 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

505 participants in 2 patient groups

SAR342434

Experimental group

Description:

SAR342434 100 Unit/mL (U/mL) before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26.

Treatment:

Drug: SAR342434

Drug: insulin glargine HOE901

Humalog

Active Comparator group

Description:

Humalog 100 U/mL before meals intake on top of QD Insulin Glargine, up to Week 26.

Treatment:

Drug: Humalog

Drug: insulin glargine HOE901