Clinical trial NCT00135083 (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
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O
Eligibility criteria:

        Subjects with type 2 diabetes mellitus who have been using a stable combination oral
        antidiabetic therapy of 2 or 3 agents in different therapeutic classes for on at least 3
        months will be enrolled in this study.

        Inclusion Criteria:

          -  Male and female subjects 18 to 79 years of age with a diagnosis of type 2 diabetes
             mellitus for at least 6 months

          -  Current treatment with a stable dose of 2 oral antidiabetic agents. The oral agents
             must be in 2 or 3 of the following 3 different classes:

               -  Sulfonylurea: dosage greater than or equal to, one-half the maximum recommended
                  dosage (eg, glimepiride >/= 4 mg; glipizide, including gastrointestinal
                  therapeutic system [GITS], >/= 10 mg; glyburide >/= 10 mg; Glynase® >/=3 mg). The
                  dosage must have been stable for at least 3 months prior to screening.

               -  Biguanide: metformin dosage ≥ 1000 mg daily, including Glucophage XR®. The dosage
                  must have been stable for at least 3 months prior to screening.

               -  Thiazolidinedione (TZD): pioglitazone >/= 15 mg or rosiglitazone >/= 24 mg. The
                  subject must have been using the same thiazolidinedione for at least 6 months,and
                  the dosage must have been stable for at least 3 months prior to screening.

          -  HbA1c >/= 8.0%

          -  Fasting C-peptide concentration > 0.27 nmol/L

          -  Able and willing to perform self-monitoring of blood glucose (SMBG) up to 4 times a
             day

          -  Able and willing to adhere to, and be compliant with, the study protocol

          -  Able to read English or Spanish at the sixth-grade level in order to complete the
             subject reported outcomes component of the study

          -  Signed informed consent and Health Insurance Portability and Accountability Act
             (HIPAA) authorization

        Exclusion Criteria:

          -  Insulin use within the previous year

          -  History of hypoglycemia unawareness

          -  Acute or chronic, or history of, metabolic acidosis, including diabetic ketoacidosis

          -  Impaired renal function as shown by, but not limited to, serum creatinine ≥ 3mg/dL.
             For subjects taking metformin, serum creatinine >/= 1.5 mg/dL for males, or >/= 1.4
             mg/dL for females.

          -  Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels
             greater than 2.5 times the upper limit of normal (ULN)

          -  Clinically significant peripheral edema if subject is using a TZD

          -  History of stroke, myocardial infarction, coronary artery bypass graft, percutaneous
             transluminal coronary angioplasty, or angina pectoris, within the past 12 months

          -  History of, or current, congestive heart failure (New York Heart Association [NYHA]
             III-IV) requiring pharmacologic treatment

          -  Acute infection

          -  Any malignancy within the past 5 years, with the exception of adequately treated basal
             or squamous cell carcinoma or adequately treated cervical carcinoma in situ

          -  Current substance addiction or alcohol abuse or history of substance or alcohol abuse,
             within the past 2 years

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

          -  Pregnant or lactating females

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

          -  Impaired dexterity or vision rendering the subject unable to administer injections

          -  Known hypersensitivity to insulin glargine or insulin glulisine or any of the
             components of Lantus or Apidra

          -  Any disease or condition (including abuse of illicit drugs, prescription medications,
             or alcohol) that, in the opinion of the investigator or sponsor, may interfere with
             the completion of the study

          -  Unlikely to comply with the protocol, eg, uncooperative attitude, inability to return
             for follow-up visits, or unlikely to complete 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

          -  No subject will be allowed to enroll in this study more than once.