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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT04877366
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to sign written informed consent prior to study entry.
* Participants who self-identify as Asian; male or female, \>18 years of age.
* Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a documented diagnosis of type 2 diabetes).
* Treatment naïve or on active therapy with metformin at a daily dose of 500-3000 mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
* Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
* Participants must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.
Exclusion Criteria:
* Fasting plasma glucose \>220 mg/dl at screening.
* Impaired kidney function, eGFR of \<60 mL/min/1.73 m2 at screening.
* BMI \>35 kg/m2.
* Weight ≤ 50 kg.
* Elevated liver transaminase \> 3 ULN at screening.
* Ongoing or recent (i.e. \< 3 month) treatment with any oral or injectable glucose-lowering drug other than metformin.
* Ongoing or recent (i.e. \< 3 month) injectable insulin therapy.
* Ongoing or recent (i.e. \< 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss \>5% within previous 6 months.
* Ongoing or recent (i.e. \< 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
* Major medical/surgical event requiring hospitalization in the last 3 months.
* Known allergy and intolerance to product components or paracetamol.
* Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
* Are unable to comply with protocol procedures in the opinion of the investigator.
* Have a hierarchical link with the research team members.
* Positive pregnancy test or breast-feeding at screening.
* Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening.
* Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04877366
Study Brief:
Protocol Section:
NCT04877366