opal - insulin glulisine, diabetes mellitus

Conditions: Diabetes Mellitus Type 2

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


Eligibility criteria:
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