Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 1:01 AM
NCT ID:
NCT01182493
Eligibility Criteria:
Inclusion Criteria at screening:
1. Diagnosed with type 2 DM, as per Investigator discretion
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 of insulin per day
4. Aged 30 to 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
at randomisation:
1. Diagnosed with type 2 DM, as per Investigator discretion
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 of 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 phase.
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
Exclusion Criteria :
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
* 2nd degree Mobitz type II or 3rd degree heart block
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 him/her 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 pramlintide (Symlin)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT01182493
Study Brief:
Protocol Section:
NCT01182493