Primary objective:
The primary study objective is to compare efficacy of Insulin glulisine, once a day at
breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin
glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual
patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy
regimens receiving two different injection timing of Insulin glulisine.
Secondary objective:
Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a
day at breakfast vs. Insulin glulisine given once a day at main meal in combination with
insulin glargine + OAD in terms of:
- Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose
(baseline to endpoint)
- Change of fasting plasma glucose (baseline to endpoint)
- Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study
endpoint
- Insulin dose (rapid-acting, basal and total daily doses)
- Weight, body-mass index
- Hypoglycemic events
- Adverse events