Insulin Glargine in Type 1 Diabetes Mellitus

Inclusion criteria:

• Subjects with type 1 diabetes mellitus for more than three years
• Subjects on multiple daily injection insulin therapy, basal-bolus scheme therapy
• HbA1c <= 9 % (measured by central Lab, with DCCT aligned standard method)
• Fasting C-Peptide <= 0,1nmol/L with FBG >126 mg/dl
• Body Mass Index (BMI) < 30 kg/m2
• Willingness to accept intensive insulin therapy
• Ability and willingness to perform SMBG using plasma glucose meter
• Female subjects must be postmenopausal or under adequate contraception as judged by the investigator (it may be oral contraceptives, intra-uterine device or surgical treatment) and must have a negative serum pregnancy test

Exclusion criteria:

• Diabetes other than type 1 diabetic mellitus
• Type 1 diabetic patients with total insulin dose >= 1 IU/kg/day
• Serum creatinine > 1.5 mg/dl, or history of renal transplantation or current renal dialysis
• Congestive heart failure NYHA class II
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis
• Clinical evidence of active liver disease, or serum ALT/AST 2 times the upper limit of the normal range
• Hypoglycemia unawareness
• Pregnancy or lactation
• Concomitant use of β-blockers, thiazides or systemic corticosteroids
• More than one episode of severe hypoglycemia with seizure or coma during the past year
• Likelihood of requiring treatment during the study period with any anti-diabetic drug other than the study drugs
• Failure to use adequate contraception (women of current reproductive potential only)
• Known hypersensitivity to insulin glargine, or any of the excipients
• Malignancy except basal cell carcinoma within the last five years
• Long lasting (> 2 weeks) treatment with systemic glucocorticoid therapy
• Known adrenal insufficiency (interferes with hypoglycemia counter-regulation)
• Known hemoglobinopathy or chronic anemia because it may interfere with Hb1Ac determination
• History of substance or alcohol abuse within the last two years or current addiction to substances of abuse including ethanol
• History of positive HIV test or Hepatitis B/C test
• Any usage outside of the current SPC (Summary of the Product Characteristics)
• Any clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease other than type 1 diabetic mellitus making implementation of the protocol or interpretation of the study results difficult
• History of demonstrable micro- and macro-angiopathic complications
• Pre-planned surgery during the study
• Blood donation of more than 500 ml during the previous 3 months for males or 6 months for females
• Smoker for previous 3 months
• Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry.