Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine (GEMELLI1)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus

Treatments: Drug: Insulin glargine (HOE901); Drug: Insulin aspart; Drug: NovoLog/NovoRapid

Study type: Interventional

Funder types: Industry

Identifiers

NCT03211858

2017-000091-28 (EudraCT Number)

U1111-1191-5775 (Other Identifier)

EFC15081

Details and patient eligibility

About

Primary Objective:

To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®.

Secondary Objectives:

• To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of positive/negative status and anti-insulin antibody (AIA) titers during the course of the study.
• To assess the relationship of AIAs with efficacy and safety.
• To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of participants reaching HbA1c lesser than (<) 7.0% and change in HbA1c, fasting plasma glucose (FPG), and self-measured plasma glucose (SMPG) profiles from baseline to Week 26 and Week 52 (only Week 52 for HbA1c).
• To assess safety of SAR341402 and NovoLog/NovoRapid.

Full description

The study consisted of a 2-week screening period, a 26-week treatment period, a 26-week comparative safety extension period, and a 1-day follow-up period. The maximum study duration was 54 weeks per participant and a 1 day safety follow-up.

Enrollment: 597 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• Participants with T1DM or T2DM (T2DM US only) diagnosed for at least 12 months, who have been treated with a multiple daily injection regimen with
• NovoLog/NovoRapid or insulin lispro (100 U/mL) in the last 6 months prior to screening visit AND
• insulin glargine (100 U/mL) in the last 6 months prior to screening visit OR insulin detemir (Levemir®) in the last 12 months prior to screening visit.

Exclusion criteria:

• At screening visit, age under legal age of adulthood.

• HbA1c <7.0% or greater than (>) 10% at screening.

• Less than 1 year on continuous insulin treatment.

• Use of insulin pump in the last 3 months before screening visit.

• Participants with incomplete baseline 7-point SMPG profile, defined as participants who do not have 7-point profiles with at least 5 points on at least 2 days in the week before randomization Visit 3.

• Participants with T1DM: Use of glucose lowering agents other than insulin including use of non-insulin injectable peptides in the last 3 months prior to screening.

• Participants with T2DM:

  • Use of glucagon-like peptide-1 (GLP-1) receptor agonists in the last 3 months before screening visit.
  • Use of oral antidiabetic drugs (OADs) not on stable dose in the last 3 months before screening visit (sulfonylureas was discontinued at baseline).

• At screening visit, body mass index (BMI) greater than or equal to (>=) 35 kilogram per meter square (kg/m^2) in participants with T1DM and >=40 kg/m^2 in participants with T2DM.

• Use of insulin other than:

  • insulin glargine 100 U/mL and NovoLog/NovoRapid or insulin lispro 100 U/mL as part of a multiple injection regimen in the last 6 months before screening visit, OR
  • insulin detemir 100 U/mL in the 12 months before screening visit and NovoLog/NovoRapid or insulin lispro 100 U/mL in the last 6 months before screening visit as part of a multiple injection regimen.

• Status post pancreatectomy.

• Status post pancreas and/or islet cell transplantation.

• Hospitalization for recurrent diabetic ketoacidosis in the last 3 months before screening visit.

• History of severe hypoglycemia requiring Emergency Room admission or hospitalization in the last 3 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.

• Pregnant or breastfeeding women.

• Women of childbearing potential not protected by highly effective method(s) of birth control.

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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597 participants in 2 patient groups

SAR341402

Experimental group

Description:

SAR341402 subcutaneous (SC), before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.

Treatment:

Drug: Insulin aspart

Drug: Insulin glargine (HOE901)

NovoLog/NovoRapid

Active Comparator group

Description:

NovoLog/NovoRapid SC, before meals intake on top of QD Insulin Glargine, up to Week 52.

Treatment:

Drug: NovoLog/NovoRapid

Drug: Insulin glargine (HOE901)