OpT2mise Glucose Control in Type 2 Diabetes Mellitus (DM) With Insulin Pump Therapy

Inclusion Criteria at screening:

• Diagnosed with type 2 DM, as per Investigator discretion
• HbA1c (DCCT-standard) must be ≥ 8.0% and ≤12% as evidenced by central lab value taken at screening
• Insulin resistance defined as required daily dose between 0.5-1.8 U/Kg or a maximum of 220 units of insulin per day
• Aged 30 to 75 years old (inclusive)
• On MDI regimen (basal/bolus regimen with long-acting insulin and rapid acting analogs) defined as ≥ 3 injections per day for at least 3 months prior signing the informed consent
• Ability to comply with technology, according to Investigator's judgment
• Patients must be willing to undergo all study procedures
• Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator

at randomisation:

• Diagnosed with type 2 DM, as per Investigator discretion
• HbA1c (DCCT-standard) must be ≥ 8.0% and ≤12% as evidenced by central lab value
• Insulin resistance defined as required daily dose between 0.7-1.8 U/Kg or a maximum of 220 units of insulin per day
• On MDI (basal/bolus regimen with long-acting insulin and rapid acting analogs) defined as ≥ 3 injections per day
• Ability to comply with technology, according to Investigator's judgment
• ≥ 2.5 SMBG per day on average, as reported in Carelink clinical during the run-in phase.
• Patients must be willing to undergo all study procedures
• Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator

Exclusion Criteria

• Subject has a history (≥ 2 events) of hypoglycemic seizure or hypoglycemic coma within the last 6 months
• Subject is pregnant as assessed by a pregnancy test with central laboratory, or plans to become pregnant during the course of the study
• Participation in another interventional clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
• Subject has proliferative retinopathy or sight threatening maculopathy
• Subject has
• an acute coronary syndrome (myocardial infarction or unstable angina) within 12 months OR
• coronary artery revascularization by bypass surgery or stenting within 3 months OR
• a transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 3 months OR
• hospitalization for heart failure within 3 months or current New York Functional Class III or IV OR
• current 2nd or 3rd degree heart block OR
• symptomatic ventricular rhythm disturbances OR
• thromboembolic disease within the last 3 months OR
• 2nd degree Mobitz type II or 3rd degree heart block
• Subject with renal impairment expressed as estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula 180 mmHg
• Diastolic blood pressure on screening visit is > 110 mmHg
• Any other disease (eg active cancer under treatment) or condition including abnormalities found on the screening tests, that in the opinion of the Investigator, may preclude him/her from participating in the study
• Taking any medication prescribed for weight loss
• Alcohol or drug abuse, other than nicotine, at the investigator's discretion
• Use of a GLP-1 agonist or pramlintide (Symlin)