12 Week,Comparing Safety of HMR1964 & Insulin Aspart Used in Continuous Subcutaneous Infusion in Type 1 Diabetes.

Exclusion Criteria

• •Subjects presenting with any of the following will not be included in the study:
• •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) during the study.
• •Diabetes other than type 1 diabetes mellitus.
• •History of serious ketosis episode requiring hospitalization in the 3 previous months.
• •History of abscess at the infusion site in the previous 3 months.
• •Pancreatectomised subjects.
• •Subjects who have undergone pancreas and or islet cell transplants.
• •Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (see Section 6.2).
• •Treatment with any investigational drug in the last month before visit 1.
• •History of seizure disorders.
• •History of hypersensitivity to insulin or insulin analogues or any other excipients in the HMR1964 or insulin aspart formulation (see the Global Investigators Brochure \[7\] and the insulin aspart SPC \[13\] for a list of excipients).
• •Clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or would, in the opinion of the investigator, preclude the safe participation of the subject in this protocol.
• •History of drug or alcohol abuse.
• •Impaired hepatic function, as shown by but not limited to ALT or AST greater than twice the normal upper limit measured at visit 1.
• •Impaired renal function, as shown by but not limited to serum creatinine \>177 micromol/L (\>2.0 mg/dL) measured at visit 1.
• •Pregnancy (as determined by pregnancy blood test at visit 1) or breast-feeding.
• •Night shift workers.
• •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• •Subject unlikely to comply with protocol, e.g. an inability and unwillingness to participate in adequate training, an uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
• •Employee of the sponsor or of sponsor representatives.
• •Subjects who have previously been treated with HMR1964.