Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT03211858
Eligibility Criteria:
Inclusion criteria :
* Participants with T1DM or T2DM (T2DM US only) 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.
Exclusion criteria:
* At screening visit, age under legal age of adulthood.
* HbA1c \<7.0% or greater than (\>) 10% at screening.
* Less than 1 year on continuous insulin treatment.
* Use of insulin pump in the last 3 months before screening visit.
* Participants with incomplete baseline 7-point SMPG profile, defined as participants who do not have 7-point profiles with at least 5 points on at least 2 days in the week before randomization Visit 3.
* Participants 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.
* Participants 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 was discontinued at baseline).
* At screening visit, body mass index (BMI) greater than or equal to (\>=) 35 kilogram per meter square (kg/m\^2) in participants with T1DM and \>=40 kg/m\^2 in participants 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.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03211858
Study Brief:
Protocol Section:
NCT03211858