Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine (SORELLA1)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02273180

U1111-1131-5038 (Other Identifier)

2013-002945-12 (EudraCT Number)

EFC12619

Details and patient eligibility

About

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.

Full description

The study consisted of a:

• Up to 2 weeks screening period
• 26-week treatment period
• 26-week comparative safety extension period
• 1-day follow-up period
• The maximum study duration would be 54 weeks per participant and a 1-day safety follow-up

Enrollment: 507 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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507 participants in 2 patient groups

SAR342434

Experimental group

Description:

SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.

Treatment:

Drug: SAR342434

Drug: Insulin glargine HOE901

Humalog

Active Comparator group

Description:

Humalog before meals intake on top of QD Insulin Glargine, up to Week 52.

Treatment:

Drug: Humalog

Drug: Insulin glargine HOE901