Clareo Health | Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
The study will consist of a: up to 2 weeks screening period, 26-week treatment period, and 1-day follow-up period.
The maximum study duration will then be 28 weeks per participant and a 1-day safety follow-up.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants with T2DM diagnosed for at least 12 months and treated with insulin glargine and Humalog®/Liprolog® or NovoLog®/NovoRapid® (at least 3 times daily, before each meal) in the 6 months prior to the screening visit.
Signed written informed consent.
You may not be if
At screening visit, age under legal age of adulthood.
HbA1c \<6.5% or \>10.0% at screening.
Diabetes other than T2DM.
Pregnancy and lactation.
Women of childbearing potential not protected by highly effective contraceptive method of birth control.
Use of insulin pump in the 6 months before screening visit.
Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6 months prior to screening visit. Liprolog® is an European Union (EU) approved insulin lispro and is allowed in those countries where it is marketed.
Use of Humalog/Liprolog or Novolog/NovoRapid less than 3 times daily, before each meal.
Use of non-injectable peptides (eg, Glucagon-like peptide-1 (GLP-1) receptor-agonists or other peptides) in the 6 months prior to screening visit.
Body mass index (BMI) \>=40kg/m² at screening visit.
Hospitalization for diabetic ketoacidosis in the last 6 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.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial
