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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Glycosylated Haemoglobin (HbA1c) Value
Glycosylated 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.
Time frame: at screening (week - 2), week 12 (if available) and 24
Self Measured Blood Glucose (SMBG)
Time frame: at Baseline (week 0), week 2, 12 and 24
DTSQs (Diabetes Treatment Satisfaction Questionnaire - status)
Time frame: at week 0, 12 and 24
DTSQc (Diabetes Treatment Satisfaction Questionnaire - change)
Time frame: at week 24
ITSQ (Insulin Treatment Satisfaction Questionnaire)
Time frame: at week 0, 12 and 24
Hypoglycemic events
Time frame: at week 0, 2, 12 and 24
Adverse Events (excluding hypoglycemic events)
Time frame: at week - 2, 0, 2, 12 and 24
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