OPAL - Insulin Glulisine, Diabetes Mellitus

Summary

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

Timeline

Start

2004-07

Primary completion

2006-09

Completion

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Drugs

Indications