Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy

Inclusion Criteria:

• Have Type 2 Diabetes (per World Health Organization [WHO] Classification of Diabetes)
• Have been treated with CSII therapy using a rapid-acting analog for the previous 6 months
• Have a screening A1C less than or equal to 9.0% (no lower limit for A1C)
• Have a body mass index (BMI) less than 45 kg/m2 at screening
• Have a history of stable body weight (not varying by greater than 10% for at least 3 months prior to screening)
• For subjects on oral anti-diabetes medications (OAMs): must have been on a stable dose of OAMs, labeled for use with insulin, for at least 3 months prior to study entry

Exclusion Criteria:

• Have severe insulin resistance (require greater than 2 U/kg/day of insulin)
• Are taking or have taken within the last 3 months, antihyperglycemic medication not approved for use with insulin, injectable non-insulin antihyperglycemic medications, or have a contraindication to current antihyperglycemic medication
• Have a serum creatinine greater than or equal to 2 mg/dL if not on metformin; known metabolic or lactic acidosis; any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis; and/or a radiologic contrast study within 48 hours prior to study entry
• Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intraarticular, and inhaled preparations) or have received such therapy within 2 weeks immediately before screening
• Have had more than 1 episode of hypoglycemia (defined as requiring assistance of a third party due to disabling hypoglycemia) within 6 months prior to entry into the study