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