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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT04965051
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 and ≤75 years with type 1 diabetes;
* Diagnosed as T1DM ≥ 12 months before enrollment in the study;
* HbA1c ≥ 7.0 to ≤10.0%;
* Receipt of basal plus pre-prandial insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study;
* BMI ≤ 35kg / m2.
Exclusion Criteria:
* Patients with any of the following conditions will be excluded:
* Pregnant or lactating women
* Severe hypoglycemia within one month;
* Myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent
* Receipt of Sulfonylureas, Meglitinides derivatives, Thiazolidinediones, Dpp-4 inhibitors or GLP-1 agonists within 3 months prior to informed consent;
* Current treatment with systemic steroids or immunosuppressive agents, or have immunologic deficiency disease at time of informed consent
* Severe mental instability, or alcohol abuse, or drug abuse
* Cancer within 5 years prior to informed consent
* Pancreatitis of severe infectious diseases within 1 months prior to informed consent
* Known hypersensitivity or allergy to the insulin
* Renal impairment (CKD-EPI eGFR\<60ml/min)
* Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined
* Participation in another trial within 2 months prior to informed consent
* Patients that investigators believe may fail to complete the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04965051
Study Brief:
Protocol Section:
NCT04965051