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

Phase 1

• Conditions: Type 1 diabetes mellitus Type 2 diabetes mellitus; MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-000091-28-HU
• Lead Sponsor: Sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-12
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 700

Inclusion Criteria

-Patients with T1DM or T2DM 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified