Glulisine + Lantus in Type I Patients

26-week, International Multicenter, Open, Non-randomized Phase III Clinical Trial for Evaluation of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Subjects With Type 1 Diabetes Mellitus Also Using Insulin Glargine

To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus

Inclusion Criteria:

• type I diabetes mellitus (onset of diabetes under the age of 40),
• an HbA1c range of >6.5 - <11%,
• and on multiple injection regimen (more than 1 year of continuous insulin treatment),
• body mass index <35.

Exclusion Criteria:

• Active proliferative diabetic retinopathy,
• Diabetes other than type I diabetes mellitus,
• Pancreatectomised subjects,
• Subjects who have undergone pancreas and or islet cell transplants,
• Requiring treatment with not permited drugs during the study,
• Previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine,
• Hypersensitivity to insulin,
• Major systemic diseases,
• Impaired hepatic or renal function

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