OpT2mise glucose control in type 2 Diabetes Mellitus (DM) with insulin pump therapy
- Conditions
- Sugardisease10018424
- Registration Number
- NL-OMON38266
- Lead Sponsor
- Medtronic B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Criteria for Inclusion at screening
1. Diagnosed with type 2 DM, as per Investigator diagnosis.
2. HbA1c (DCCT-standard) must be * 8.0% and *12% as evidenced by central lab value taken at screening.
3. Insulin resistance defined as required daily dose between 0.5-1.8 U/Kg or a maximum of 220 units insulin per day.
4. Age between 30-75 years old inclusive.
5. 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.
6. Ability to comply with technology, according to Investigator*s judgment.
7. Patients must be willing to undergo all study procedures.
8. Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator.;Criteria for Inclusion at randomization
1. Diagnosed with type 2 DM, as per Investigator diagnosis.
2. HbA1c (DCCT-standard) must be * 8.0% and *12% as evidenced by central lab value.
3. Insulin resistance defined as required daily dose between 0.7-1.8 U/Kg or a maximum of 220 units insulin per day.
4. On MDI (basal/bolus regimen with long-acting insulin and rapid acting analogs) defined as * 3 injections per day.
5. Ability to comply with technology, according to Investigator*s judgment.
6. * 2.5 SMBG per day on average, as reported in Carelink Clinical during the run-in period.
7. Patients must be willing to undergo all study procedures.
8. Female patients of child-bearing potential must be using adequate contraception means as assessed by Investigator.
Criteria for Exclusion (screening and randomization)
1. Subject has a history (* 2 events) of hypoglycemic seizure or hypoglycemic coma within the last 6 months
2. Subject is pregnant as assessed by a pregnancy test with central laboratory, or plans to become pregnant during the course of the study
3. Participation in another interventional clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
4. Subject has proliferative retinopathy or sight threatening maculopathy
5. 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
6. 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
7. Subject has taken oral or injectable steroids within the last 30 days
8. Systolic blood pressure on screening visit is > 180 mmHg
9. Diastolic blood pressure on screening visit is > 110 mmHg
10. 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 the patient from participating in the study
11. Taking any medication prescribed for weight loss
12. Alcohol or drug abuse, other than nicotine, at the Investigator*s discretion
13. Use of a GLP-1 agonist or pramlitide (Symlin®). GLP-1 slows gastric emptying, thereby decreasing the rate of glucose absorption. Pramlitide (Symlin®) is a commercially available analogue of amylin, a synergistic partner to insulin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint:<br /><br>* Between group difference in average HbA1c changes from baseline to 6 months,<br /><br>when comparing CSII to MDI</p><br>
- Secondary Outcome Measures
Name Time Method