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 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT02367066
Eligibility Criteria:
Inclusion Criteria
* Provision of informed consent
* Male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18.
* Patients with HbA1c ≥7.5 but ≤11% at enrolment visit (Visit 1)
* ody mass index \>19 to \<38 kg/m2
* he fasting plasma glucose should be in the range of 3-14 mmol/L (54-252 mg/dL, nclusive) on the morning of Visit 1.
* Clinical diagnosis of type 2 diabetes mellitus
* Metformin as only anti-diabetic treatment, at least for the last 3 months
Exclusion Criteria:
* History or sign of any clinically significant disease or disorder which, in the opinion f the investigator, may either put the subject at risk because of participation in the sudy, or influence the results or the subject's ability to participate in the study
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory results \>3x upper level of normal range (ULN) Clinical diagnosis of Type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase Autoantibodies test (GAD antibodies test).
* Patients treated with single Insulin therapy within the last 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
130 Years
Study:
NCT02367066
Study Brief:
Protocol Section:
NCT02367066