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



Status:Completed
Conditions:Diabetes, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:2/20/2019
Start Date:August 2, 2017
End Date:January 12, 2019

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Six-month, Randomized, Open-label, Parallel-group Comparison of SAR341402 to NovoLog®/NovoRapid® in Adult Patients With Diabetes Also Using Insulin Glargine, With a 6-month Safety Extension Period

Primary Objective:

To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin
A1c (HbA1c) change from baseline to Week 26 in patients 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
patients reaching HbA1c <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.

The study will consist 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
will then be 54 weeks per patient and a 1 day safety follow-up.

Inclusion criteria :

- Patients 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.

- Glycated hemoglobin (HbA1c) <7.0% or >10% at screening.

- Less than 1 year on continuous insulin treatment.

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

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

- Patients 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.

- Patients 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 will be discontinued at baseline).

- At screening visit, body mass index (BMI) ≥35 kg/m2 in patients with T1DM and ≥40
kg/m2 in patients 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 patient's
potential participation in a clinical trial.
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