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

The type of study is interventional post-market release. All the devices under investigation have CE mark, and are used within intended use.

This study has been designed to be prospective randomized controlled with a single-arm cross-over in the continuation phase.

Four hundred type 2 Multiple Daily Injections (MDI) treated patients will undergo a screening (run-in) phase of 8 weeks. The aim of the screening phase is to eliminate the study effect that might result in a decrease of HbA1c and to make sure that patients, who are failing current MDI therapy, are selected.

After this screening phase, eligible patients will be randomised to receive either Continuous Subcutaneous Insulin Infusion (CSII) treatment or continue MDI treatment. The study phase is a 6-months phase with 2-arms parallel design.

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 < 30 ml/min as demonstrated by the screening central laboratory value at the time of enrollment
• Subject has taken oral or injectable steroids within the last 30 days
• Systolic blood pressure on screening visit is > 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)