Clinical trial NCT00135096 (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 glulisine, insulin glargine
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O, [Na+].[Na+].[O-]P([O-])(F)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 2 diabetes mellitus for at least six months

          -  18 to 70 years of age, inclusive

          -  A1c ≥ 7.5% and ≤ 10%

          -  At least 3 months of continuous insulin and/or insulin analogue therapy (on at least 2
             injections per day) +/- metformin prior to study entry

          -  Negative glutamic acid decarboxylase (GAD) autoantibodies

          -  Ability and willingness to perform self-monitoring of blood glucose (SMBG) at least
             four times a day, and at least 7 times daily during the 7-point blood glucose (BG)
             profile measurement days

          -  Ability and willingness to adhere to, and be compliant with, the study protocol

          -  Must be able to read English or Spanish at the sixth grade level in order to complete
             the patient-reported outcomes component of the study

          -  Signed informed consent

        Exclusion Criteria:

          -  Subjects treated with sulfonylureas, thiazolidinediones (TZDs), or any other oral
             antidiabetic drugs (at study entry) except for insulin and/or insulin analogues with
             or without metformin

          -  Planned pregnancy; or pregnant or lactating females

          -  For subjects treated with metformin: serum creatinine ≥ 1.5 mg/dL (133 µmol/L) for
             males or ≥ 1.4 mg/dL (124 µmol/L) for females

          -  Serum creatinine ≥ 3.0 mg/dL (266 µmol/L)

          -  Any clinically significant renal disease (other than proteinuria) or hepatic disease

          -  Serum ALT or AST levels greater than 2.5 X the upper limit of normal

          -  Any current malignancy or any cancer within the past 5 years (except for adequately
             treated basal cell skin cancer or cervical carcinoma in situ)

          -  Diagnosis of dementia or mental condition rendering the subject unable to understand
             the nature, scope, and possible consequences of the study

          -  Diagnosis of impaired dexterity or vision rendering the subject unable to administer
             multiple daily injections (MDIs)

          -  Cardiac status New York Heart Association (NYHA) III-IV

          -  Hypersensitivity to Lantus or Apidra or any of their components

          -  Any disease or condition (including abuse of illicit drugs, prescription medicines or
             alcohol) that, in the opinion of the investigator or sponsor, may interfere with the
             completion 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 is the investigator or any sub-investigator, research assistant, pharmacist,
             study coordinator, other staff or relative thereof directly involved in the conduct of
             the protocol