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:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT02104804
Eligibility Criteria:
Inclusion Criteria:
1. Provision of informed consent before participating in the study.
2. Diagnosed with type 2 diabetes.
3. Inadequate glycemic control (screening: HbA1c ≥7.5% and ≤11.0% and FPG\<270 mg/dL (15mmol/L). At Day -4 visit, HbA1c ≥7.5% and ≤10.5%. and FPG\<270 mg/dL (15mmol/L)).
4. On a stable dose of insulin for 8 weeks or longer prior to screening.
5. If taking metformin, subjects should have been taking the same daily dose for 8 weeks or longer prior to screening.
6. Insulin type should be intermediate-acting or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as one component).
7. Body mass index ≤45 kg/m\^2.
Exclusion Criteria:
1. Women of childbearing potential unable or unwilling to use acceptable birth control.
2. Women who are pregnant or breastfeeding.
3. Symptoms of poorly controlled diabetes. including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the last three months prior to screening or other signs and symptoms.
4. Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable clinical significant arrhythmia, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.
5. Congestive heart failure
6. Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled).
7. History of unstable or rapidly progressing renal disease.
8. History of alcohol or drug abuse within the previous year.
9. Unstable major psychiatric disorders.
10. History of hemoglobinopathies
11. Immunocompromised status
12. Severe liver disease.
13. In subjects treated with insulin alone a calculated creatinine clearance \<50 ml/min. In patients treated with insulin in combination with metformin a calculated creatinine clearance \<60 ml/min or serum creatinine \> 1.5 mg/dL in males or \> 1.4mg/dL in females.
14. Anemia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02104804
Study Brief:
Protocol Section:
NCT02104804