To compare the change in glycemic control, as measured by Hemoglobin A1c (HbA1c) from baseline to study week 24; in subjects receiving insulin glulisine as mealtime insulin following a variable bolus insulin regimen (based on carbohydrate counting) vs a fixed bolus insulin regimen; with insulin glargine as basal insulin in both arms of the study

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin glulisine  Drug: insulin glargine	Phase IV

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of Type 2 Diabetes Mellitus for at least six months, 18 to 70 years of age, inclusive
• A1c ≥ 7.0% and ≤ 10% at screening
• At least 3 months of continuous insulin and/or insulin analogues therapy (on at least 2 injections) +/- metformin prior to study entry (Note: Subjects receiving Lantus twice a day (split dose) will be considered as being on one injection only).
• Willingness of subject to discontinue other anti-diabetic drug treatments and to remain off them through the entire study
• Negative Glutamic Acid Decarboxylase (GAD) autoantibodies
• Ability and willingness to perform SMBG at least four times a day, and at least 7 times daily during the 7-point BG profile measurement days
• Ability and willingness to adhere to and be compliant with the study protocol
• Must be able to read English 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, TZDs, or any other oral antidiabetic drugs (within the 3 months before study entry) except for insulin and/or insulin analogues with or without metformin
• Planned pregnancy, 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) 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 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 MDI injections
• Cardiac status NYHA III-IV
• Hypersensitivity to Lantus or Apidra or any of its 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00135057

Public Registry USMA       PublicRegistryUSMA@sanofi-aventis.com

Ohio
      Dr. Mounir, Toledo,  Ohio,  United States; Recruiting

Study chairs or principal investigators

Karen Barch, B.S.,  Study Director,  Sanofi-Aventis   

Study ID Numbers:  HMR1964A/3502
Last Updated:  August 24, 2005
Record first received:  August 23, 2005
ClinicalTrials.gov Identifier:  NCT00135057
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30