Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs

The study is divided in 3 periods:

• a 2-week run-in period,
• a 12-week treatment period 1
• a 12-week treatment period 2 study treatment duration per patient: 24 weeks study duration per patient: 26 weeks

Inclusion criteria

• in the run-in period:

• Uncontrolled Type 2 diabetes mellitus defined as HbA1c level between 7,5% and 10% assessed over the past 6 months
• Male or female patients from 18-75 years old inclusive
• Body Mass Index (BMI) between 25 and 40 kg/m2
• Currently treated with a basal insulin (NPH, insulin zinc or insulin detemir), plus at least 1g metformin daily, and other Oral Glucose Lowering Drug (OGLD) if any for at least 3 months
• Signed Informed consent obtained prior to any study procedures
• in the treatment period:

• HbA1c level between 7,5% and 10% assessed between week -2 and week 0
• Serum creatinine <= 135 µmol/L in men and <= 110 µmol/L in women
• Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) <= 3 times the upper limit of normal
• Negative pregnancy test for women of childbearing potential

Exclusion criteria

• Type 1 diabetes mellitus
• Active proliferative diabetic retinopathy, defined as the application of photocoagulation or surgery performed within 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus performed over the past 2 years)
• Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
• History of impaired hepatic function defined as Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal
• History of impaired renal function defined as serum creatinine >135 µmol/l in men and > 110 µmol/l in women
• History of drug or alcohol abuse
• Type 2 Diabetes Mellitus (T2DM) patients treated exclusively with OGLDs
• T2DM patients treated with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
• Previous treatment with insulin glulisine
• Concomitant treatment with thiazolidinediones, exenatide or pramlintide
• Treatment with systemic corticosteroids within 3 months prior to study entry
• Treatment with any investigational product within 2 months prior to study entry
• History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
• Presence of mental condition that, in the opinion of the investigator, indicates that participation in the study is not in the best interest of the patient
• Presence of geographic or social conditions that would restrict or limit the patient participation for the duration of the study
• Pregnant or breast feeding women
• Women of childbearing potential not protected by effective contraceptive method of birth control

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