Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM

Exclusion Criteria

• •Glycated hemoglobin A1c (HbA1c) \<7.0% (\<53 mmol/mol) or \>11% (97 mmol/mol) at screening.
• •Age \<18 years at the time of screening.
• •Body Mass Index (BMI) \>40 kg/m2.
• •Diabetes other than T2DM.
• •History of T2DM for less than 1 year before screening.
• •Less than 6 months anti-hyperglycemic treatment before screening.
• •Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
• •Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonist.
• •Patients receiving only non-insulin anti-hyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides.
• •Current or previous insulin use except for a maximum of 8 consecutive days and a total of 14 days (eg, acute illness, surgery) during the last year prior to screening.
• •Any contraindication to insulin glargine (Lantus) according to the National Product labeling or any excipients.
• •Any contraindication to the mandatory background non-insulin anti-hyperglycemic medication according to the respective National Product labeling.
• •Latest eye examination by an ophthalmologist \>12 months prior to inclusion.
• •More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
• •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 patient's potential participation in a clinical trial.