Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: SAR341402 Mix 70/30: Formulation: 100 U/mL suspension for injection supplied in 3 mL pre-filled disposable SoloStar pen
Route of administration: self-administered by subcutaneous (SC)
Sponsors
Sanofi Synthelabo India Pvt Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants with type 1 or type 2 diabetes mellitus. 2. Diabetes diagnosed at least 12 months before screening 3. Participants at least twice daily on NovoMix 30, Humalog Mix 25 or Liprolog Mix 25 for at least 3 months prior to the screening visit 4. HbA1c (74.86 mmol/mol) and 10.0% (85.79 mmol/mol) can be included if they are not candidates for an MDI regimen based on the discretion of the Investigator 5. Body mass index (BMI) 6.
Exclusion criteria
Exclusion criteria: 1. Any clinically significant abnormality identified either in medical history or during screening evaluation (eg, physical examination, laboratory tests, ECG, vital signs), or any AE during screening period which, in the judgment of the Investigator, would preclude safe completion of the study or constrains efficacy assessment. 2. Pancreatectomy and/or islet cell transplantation 3. Severe renal disease defined as estimated GFR (MDRD) 4. Known presence of factors that interfere with the HbA1c measurement (eg, specific hemoglobin variants, hemolytic anemia) compromising the reliability of HbA1c assessment or medical conditions that affect interpretation of HbA1c results (eg, blood transfusion or severe blood loss in the last 3 months prior to randomization, any condition that shortens erythrocyte survival) 5. History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 26 in HbA1cTimepoint: 26 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of participants with treatment-emergent anti-insulin aspart antibodies (AIA) during the 26-week treatment period. 2. Safety evaluations, which will include evaluation of the following for the 26-week treatment period: - Number of participants with at least one hypoglycemic event - Number of hypoglycemic events per participant-year - Number of participants with adverse events (AE)Timepoint: 26 weeks | — |
Countries
India, Philippines, Poland, Russian Federation, Ukraine
Contacts
Public ContactSukanya Krishnan
Sanofi synthelabo (India) private Limited
Outcome results
None listed