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

Summary

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.

Timeline

Start

2010-01

Primary completion

2012-07

Completion

2012-07

Drugs

Indications