Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Code: SAR341402
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: insuline aspart
Current Sponsor code: SAR341402
Concentration unit: IU/ml international unit(s)/millilitre
Co
Sponsors
Sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants with type 1 or type 2 diabetes mellitus. - Diabetes diagnosed at least 12 months before screening. - Participants at least twice daily on NovoMix 30 or Humalog Mix 25 or Liprolog Mix 25 for at least 3 months prior to the screening visit. - Glycated hemoglobin A1c (HbA1c) =10.0% (85.79 mmol/mol) at screening; participants with HbA1c between 9.0% (74.86 mmol/mol) and 10.0% (85.79 mmol/mol) can be included if they are not candidates for an multiple daily injection (MDI) regimen based on the discretion of the Investigator. - Body mass index (BMI) =35 kg/m2 in participants with type 1 diabetes mellitus (T1DM) and =40 kg/m2 in participants with T2DM at the 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 390 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 210
Exclusion criteria
Exclusion criteria: - All Participants: using injectable glucose lowering treatments other than pre-mix insulin analogs within 3 months prior to screening. - Participants with T2DM: use of oral antidiabetic drugs (OADs) that are not taken at a stable dose within 3 months prior to screening. Any sulfonlyureas or glinides must be discontinued at randomization, with the last dose being taken the day prior to the first dose of Investigational Medicinal Product (IMP). - Participants using insulin pump within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of SAR341402 Mix 70/30 in comparison to NovoMix 30 on glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 and type 2 diabetes mellitus;Secondary Objective: - To compare the effects of SAR341402 Mix 70/30 and NovoMix 30 on immunogenicity parameters in participants with type 1 and type 2 diabetes mellitus. - To evaluate the safety of SAR341402 Mix 70/30 and NovoMix 30 ;Primary end point(s): Change in glycated hemoglobin A1c (HbA1c) - Change from baseline to Week 26 in HbA1c - ;Timepoint(s) of evaluation of this end point: Baseline to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Treatment-emergent anti-insulin antibodies (AIAs) - Number of participants with treatment-emergent anti-insulin antibodies (AIAs) 2) Hypoglycemic events - Number of participants with at least one hypoglycemic event 3) Hypoglycemic events per participant per year - Number of hypoglycemic events per participant-year 4) Safety: Adverse Events - Number of participants with adverse events ;Timepoint(s) of evaluation of this end point: 1), 2), 3) and 4) Baseline to week 26 | — |
Countries
India, Philippines, Poland, Russian Federation, Ukraine
Outcome results
None listed