Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus

Exclusion Criteria

• •Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness.
• •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)
• •Symptomatic hypotension (whatever the decrease in blood pressure), or asymptomatic postural hypotension defined by a decrease in systolic blood pressure equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position
• •Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment
• •Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
• •Presence or history of drug or alcohol abuse (alcohol consumption \> 40 grams / day)
• •If female, pregnancy (defined as positive Beta Human Chorionic Gonadotropin test), breast-feeding
• •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.