Clinical trial NCT00174642 (phase 3, status: completed)
Conditions: diabetes mellitus, type 2
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: insulin glargine, insulin glulisine, metformin, insulin secretagogue
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O, [Na+].[Na+].[O-]P([O-])(F)=O, CSCC[C@H](N)C(O)=O, [Na+].[Na+].[O-]P([O-])(F)=O
Eligibility criteria:

        Inclusion criteria:

          -  Type 2 diabetic

          -  BMI ≤ 40 kg/m²

          -  HbA1c > 7%

          -  Treated with basal insulin (NPH, Insulin Zinc, insulin glargine or insulin detemir),
             and at least, two OAD including an insulin secretagogue (sulfonylurea or glinide, at
             any dosage) and metformin (at the maximum tolerated dosage), for more than 6 months

        Exclusion criteria:

          -  Type 1 diabetes mellitus

          -  Treatment with OADs only

          -  Treatment with thiazolidinediones

          -  Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting
             insulin analogue)

          -  Active proliferative diabetic retinopathy, as defined by the application of
             photocoagulation or surgery, in the 6 months before study entry or any other unstable
             (rapidly progressing) retinopathy that may require photocoagulation or surgery during
             the study (confirmed by an optic fundus performed in the 2 years prior study entry)

          -  Pregnancy (women of childbearing potential must have a negative pregnancy test at
             study entry and effective contraception)

          -  Breast-feeding

          -  History of hypersensitivity to the study drug or to drugs with a similar chemical
             structure or to insulin glargine

          -  Treatment with systemic corticosteroids, irrespective of the dose of administration
             and irrespective of the prior or foreseeable treatment duration

          -  Treatment with any investigational product in the last 2 months before study entry,
             except for insulin glargine

          -  Likelihood of requiring treatment during the study period with drugs not permitted by
             the clinical study protocol

          -  Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major
             disease making implementation of the protocol or interpretation of the study results
             difficult

          -  Impaired hepatic function as shown by ALT and/or AST greater than three times the
             upper limit of normal at study entry

          -  Impaired renal function as shown by serum creatinine >135 μmol/l in men and > 110
             μmol/l in women at study entry

          -  History of drug or alcohol abuse

          -  Mental condition rendering the subject unable to understand the nature, scope and
             possible consequences of the study

          -  Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to
             return for follow-up visits, and unlikelihood of completing the study

          -  Subject deprived of freedom by a judicial or administrative decision

          -  Subject is the investigator or any subinvestigator, research assistant, pharmacist,
             study coordinator, other staff or relative thereof directly involved in the conduct of
             the protocol.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.