relative bioavailability and activity of different formulations of insulin glargine and lixisenatide in patients with diabetes mellitus type 1

Conditions: Type 1 Diabetes Mellitus

Summary: primary objective: * to assess the relative bioavailability of a single dose of insulin glargine (lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug secondary objectives: * to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug * to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix

the study period for one patient is one month in average and it can last up to 7 months (+ 2 weeks) with post-study and follow-up visits

Eligibility criteria:
inclusion criteria: * subjects with type 1 diabetes mellitus for more than one year with total insulin dose of \<1.2 u.kg/day, but otherwise healthy with glycohemoglobin (hba1c) ≤ 9.0%, stable insulin regimen for at least 2 months prior to study, normal finding in medical history and physical examination. exclusion criteria: * any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type i), 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, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure (sbp) 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 to clinically significant allergic disease * likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol * pregnant or breast feeding women * any medication within 14 days before inclusion, or within 5 times the elimination half-life of that drug, whichever the longest and regular use of any medication other than insulins in the last month before study start with the exception of 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. * positive reaction to any of the following tests: hepatitis b surface (hbs ag) antigen, antihepatitis b core antibodies (anti-hbc ab) if compound having possible immune activities, anti-hepatitis c virus (anti-hcv2) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-hiv1 and anti hiv2 ab) * history of unexplained pancreatitis, chronic pancreatitis and/or pancreatectomy the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.