Slow recruitment

Primary Objective:

To demonstrate non-inferiority of once daily injection of insulin glargine (Lantus) plus one injection of mealtime insulin glulisine (Apidra) at the main meal versus twice daily premixed insulin (NovoMix 30/70) based on the reduction of HbA1c percentage from baseline to endpoint.

Secondary Objective:

• To determine treatment satisfaction (DTSQs/Diabetes Treatment Questionnaire - Status, DTSQc/ Diabetes Treatment Questionnaire - change and ITSQ/Insulin Treatment Satisfaction Questionnaire)
• To determine the mean HbA1c, FBG (Fasting Blood Glucose), prandial BG (Blood Glucose) and proportion of patients with a HbA1c <7%
• To determine the effect on adverse events (e.g. symptomatic hypoglycemic events, weight gain and injection site reactions)
• To determine the total insulin dose, average insulin glargine, insulin glulisine and premixed insulin dosages.

Inclusion criteria:

• Patients with type 2 diabetes mellitus treated with insulin glargine once daily and oral blood glucose lowering medication
• Patients with a HbA1c > 7%
• Patients with a FBG within range (4-7 mmol/L) at baseline, based on the mean of 3 FBG values (measured 5x during the run-in phase, with the highest and lowest value excluded)

Exclusion criteria:

• Patients treated with an insulin other than insulin glargine
• Patients with hypersensitivity to insulin glargine, insulin glulisine, biphasic insulin aspart/insulin aspart protamine 30/70 or any of the excipients
• Patients with a (pre)proliferative retinopathy (an optic fundus examination should have been performed within the 2 years prior to study entry)
• Pregnant or lactating women
• Patients who are unable to fill in the PRO (Patient Reported Outcomes) questionnaires

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