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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT03215069
Eligibility Criteria:
Inclusion Criteria:
* Women with recent gestational diabetes who are between 6-36 months postpartum inclusive and no longer breastfeeding
* Age 20 - 50 years inclusive
* Negative pregnancy test at recruitment
Exclusion Criteria:
* Current breastfeeding
* Current diabetes or treatment with any anti-diabetic medication
* Involvement in any other clinical study requiring drug therapy
* Hypersensitivity to empagliflozin or the formulations of this product
* Any history of diabetic ketoacidosis
* History of recurrent urinary infection (i.e. more than 2 episodes over the past year).
* Renal dysfunction as evidenced by estimated glomerular filtration rate \< 45 ml/min by Modification of Diet in Renal Disease (MDRD) formula
* Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \>2.5X the upper limit of normal
* Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
* Pregnancy or unwillingness to use reliable contraception. Women should not be planning pregnancy for the duration of the study or the first 3 months after the study. Reliable contraception includes the following: birth control pill, intra-uterine device, abstinence, tubal ligation, partner vasectomy, or condoms with spermicide.
* Any other factor likely to limit adherence to the study, in the opinion of the investigators
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT03215069
Study Brief:
Protocol Section:
NCT03215069