BASAAL PLUS - Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting

• Glycosylated Haemoglobin (HbA1c) Value [ Time Frame: at screening (week - 2), week 12 (if available) and 24 ] [ Designated as safety issue: No ]
  Glycolysated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients.
• Self Measured Blood Glucose (SMBG) [ Time Frame: at Baseline (week 0), week 2, 12 and 24 ] [ Designated as safety issue: No ]

• DTSQs (Diabetes Treatment Satisfaction Questionnaire - status) [ Time Frame: at week 0, 12 and 24 ] [ Designated as safety issue: No ]
• DTSQc (Diabetes Treatment Satisfaction Questionnaire - change) [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
• ITSQ (Insulin Treatment Satisfaction Questionnaire) [ Time Frame: at week 0, 12 and 24 ] [ Designated as safety issue: No ]
• Hypoglycemic events [ Time Frame: at week 0, 2, 12 and 24 ] [ Designated as safety issue: No ]
• Adverse Events (excluding hypoglycemic events) [ Time Frame: at week - 2, 0, 2, 12 and 24 ] [ Designated as safety issue: No ]

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.

• Drug: Insulin glulisine
  Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
• Drug: Insulin glargine
  Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
• Drug: Premixed insulin (Insulin Aspart 30/70 )
  Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily

• Experimental: Insulin glargine + Insulin glulisine
  Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal
  Interventions:

  • Drug: Insulin glulisine
  • Drug: Insulin glargine
• Active Comparator: Premixed insulin
  twice daily premixed insulin (before breakfast and evening meal).
  Intervention: Drug: Premixed insulin (Insulin Aspart 30/70 )

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.