Clinical trial NCT01493115 (phase 1, status: completed)
Conditions: type 1 diabetes mellitus
ICD codes: E10.65, E10.9, E10.21, E10.36, E10.41, E10.42, E10.44
Drugs: insulin glargine hoe901, insulin glargine - new formulation hoe901
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O, [Na+].[Na+].[O-]P([O-])(F)=O
Eligibility criteria:

        Inclusion criteria:

          -  Japanese male or female subjects, between 20 and 65 years of age, inclusive, with type
             1 diabetes mellitus for more than one year, as defined by the Japanese Diabetes
             Society

          -  Body weight between 50.0 kg and 95.0 kg

          -  Body Mass Index between 18.0 and 30.0 kg/m2 inclusive

          -  Stable insulin regimen for at least 2 months prior to study

          -  Certified as otherwise healthy for type 1 diabetes mellitus patient by assessment of
             medical history and physical examination

          -  Women of childbearing potential must have a negative pregnancy test and must use a
             highly effective method of birth control. During the entire study female subjects of
             child bearing potential must use two independent methods of contraception. The
             accepted double contraception methods include use of an intra-uterine device or
             hormonal contraception in addition to one of the following contraceptive options: 1)
             condom; 2) diaphragm 3) spermicide.

        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

          -  Presence or history of a drug allergy or clinically significant allergic disease
             according to the Investigator's judgment

          -  Participation in a trial with any investigational drug during the past 4 months

          -  Symptoms of a clinically significant illness in the 3 months before the study, which,
             according to the investigator's opinion, could interfere with the purposes of the
             study

          -  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

          -  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.