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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT06999551
Eligibility Criteria:
Inclusion Criteria:
* Ageā„ 18 and \<70
* Type 2 diabetic patients, with a duration of NPH between 5 and 10 years.
* Patients treated with a double dose of NPH insulin with a stable dose of insulin and a stable dose of ADO (oral antidiabetic drugs) for at least 2 months prior to the start of the study.
* An HbA1c level between 7% and 10%
* Ability to use a continuous glucose monitoring (CGM) system and cycle blood glucose with the meter.
* Written informed consent obtained prior to participation in the study.
Exclusion Criteria:
* Pregnant and breastfeeding women
* Patients with active proliferative and/or complicated diabetic retinopathy, treated by photocoagulation or surgically, within 6 months prior to study entry or any other rapidly progressing unstable retinopathy that may require photocoagulation or surgery during the study (plan to perform fundus prior to inclusion).
* History of insulin glargine hypersensitivity
* Treatment with systemic, neuroleptic, immunosuppressive and antiretroviral corticosteroids within 3 months prior to study entry and during the study and other treatments, which may significantly affect blood glucose.
* Severe renal impairment at baseline defined by a \< 30ml/min.
* Patients on sulfonylurea drugs or glinides or on more than three oral antidiabetic drugs (ODAs)
* Patients on rapid insulin.
* Patients Enrolled in Other Clinical Studies
* Patients who refuse to sign consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06999551
Study Brief:
Protocol Section:
NCT06999551