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 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT03258268
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* ≥ 18 years of age at the time of signing informed consent
* Type 2 diabetes (diagnosed clinically) ≥ 6 months prior to screening
* HbA1c ≥ 7.0 \[58 mmol/mol\] by central laboratory analysis
* Stable daily treatment with any single antidiabetic drug or any combination of antidiabetic drugs for at least 90 days prior to screening (dose adjustment ±10% of insulin dose and temporary dose correction because of e.g. infection are allowed)
Exclusion Criteria:
* Previous participation in this trial. Participation is defined as informed consent.
* Currently participating in other clinical trials for diabetes
* Type 1 diabetes diagnosed clinically and/or by the presence of diabetes-associated autoantibodies
* History of diabetic ketoacidosis or hyperosmolar hyperglycemic state
* Corticosteroid-induced or pancreatitis-induced diabetes
* History of chronic or acute pancreatitis
* Known or suspected substance abuse
* Pregnancy
* Anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids or statins)
* Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg)
* Renal failure stage 5, defined as (estimated or exact) glomerular filtration rate \< 15 mL/min/1.73m2
* Recent or planned major surgery (such as gastric bypass operation)
* Major psychiatric disorders, mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with the trial site personnel
* Life-threatening disease including malignant neoplasms and medical history of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03258268
Study Brief:
Protocol Section:
NCT03258268