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: 100
Conditions
Interventions
Product Code: SAR341402
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: insulin aspart
CAS Number: 116094-23-6
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: -At screening visit, age under legal age of adulthood. -Glycated hemoglobin (HbA1c) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 Objective: -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. ;Primary end point(s): Change in glycated hemoglobin (HbA1c) (%) from baseline;Timepoint(s) of evaluation of this end point: Baseline to Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change in HbA1c(%) from baseline 2) The percentage of patients with HbA1c <7 % 3) Change from baseline in FPG 4)Change from baseline in the mean 24-hour plasma glucose concentration, based on the 7-point SMPG profiles 5) Change from baseline in postprandial plasma glucose excursions at breakfast, lunch and dinner, based on the 7-point SMPG profiles 6) Change from baseline in 7-point SMPG profiles per time-point 7) Number of patients with hypoglycemia event 8) Number of hypoglycemia events per patient 9) Anti-SAR341402/NovoLog/NovoRapid antibody positive/negative status, titers and cross-reactivity to human insulin at each sampling visit 10) Treatment-induced, treatment-boosted and treatment-emergent anti-insulin antibodies (AIAs) ; Timepoint(s) of evaluation of this end point: 1) Baseline to Week 52 2), 7), 8), 9) and 10) At week 26, week 52 3), 4), 5) and 6) Baseline to Week 26; Week 52 | — |
Countries
Finland, Germany, Hungary, Japan, Poland, Russian Federation, United States
Contacts
Public ContactNA.
sanofi-aventis Zrt.
Outcome results
None listed