OPAL - Insulin Glulisine, Diabetes Mellitus

Inclusion criteria: * Type 2 Diabetes mellitus, previously treated with combination therapy of insulin glargine + OAD (maximal tolerated dose / approved in combination with insulin according to local SPCs (Summary of Product Characteristics), not including use of a-glucosidase inhibitors) for at least 3 months * Pre-screening HbA1c value greater/equal 7% - smaller/equal 9% * FBG (Fasting Blood Glucose) smaller/equal 120 mg/dl (6.6 mmol/l) * Women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years) or are not pregnant and agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide. * Ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter and subject diary at home Exclusion criteria: * More than two FBG greater 120 mg/dl (6.6 mmol/l) as measured on 5 consecutive days before visit II * Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation) * Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult * Known impaired hepatic and renal function * History of drug or alcohol abuse * History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine formulation * Treatment with any investigational drug in the last month before visit I * Pregnant or breast-feeding women, or women planning to become pregnant during the study * Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol * Night shift workers if they are unable to comply with the treatment regimen