Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With Lantus

Exclusion Criteria

• •More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
• •Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month).
• •Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment.
• •Presence or history of drug or alcohol abuse (alcohol consumption \>40 grams / day).
• •Smoking more than 5 cigarettes or equivalent per day, unable to refrain from smoking.
• •Any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, whichever the longest and regular use of any medication in the last month before study start with the exception of insulin products, thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days; any biologics (antibody or its derivatives) given within 4 months before randomization.
• •Known hypersensitivity to insulin glargine or excipients of the study drug.
• •Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children).
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.