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:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT06770894
Eligibility Criteria:
Inclusion Criteria:
* Female subjects ≥ 18 years
* Diagnosis of Type 2 Diabetes according to American Diabetes Association 2009 criteria
* Body mass index (BMI) between 20-40 kg/m2
* Body weight ≤ 120 kg (due to limitations imposed by DXA equipment);
* HbA1c \< 7.5%
* Treatment with metformin in monotherapy at a stable dose for ≥12 weeks prior to enrolment
* Women not of childbearing potential may participate and include those who are:
I) infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenisis; or II) postmenopausal - defined as either
1. A woman 50 to 54 years of age (inclusive) with an intact uterus, not hormone therapy who has had either
1. cessation of menses for at least 1 years or
2. at least 6 months of spontaneous amenorrhea with a follicle-stimulating hormone \> 40 mIU/mL; or
2. a woman 55 or holder not on hormone therapy, who has had at least 6 months of spontaneous amenorrhea; or
3. a woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy - Women of childbearing potential participating: I) cannot be pregnant or intend to become pregnant II) cannot be breastfeeding III) must remain abstinent or use 1 highly effective method of contraception or combination of 2 effective methods of contraception for the entirety of the study IV) test negative for pregnancy at the time of screening
Exclusion Criteria:
* Treatments known to significantly influence bone metabolism (e.g. bisphosphonates, calcitonin, corticosteroids or hormone replacement therapy)
* Osteomalacia
* Paget.s disease
* Hyperparathyroidism
* Hyperthyroidism
* Chronic liver failure/cirrhosis
* Kidney failure
* Current or history of therapy with antidiabetic agents other than metformin
* Pregnancy/lactation, childbearing potential women who do not give their consent to remain abstinent or use 1 highly effective method of contraception or combination of 2 effective methods of contraception for the entirety of the study
* Pregnancy/lactation
* Substance abuse, clinically significant depression or current psychiatric care
* Refuse or are unable to give informed consent to participate in the study Subjects taking vitamin D and/or calcium supplements at enrolment will be instructed to continue this therapy keeping the doses unchanged throughout the entire study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06770894
Study Brief:
Protocol Section:
NCT06770894