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 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT06449235
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed T2DM (according to American Diabetic Association, ADA guideline) aged (≥ 18 years) treated with stable doses of antidiabetic medications (with or without omarigliptin) along with standard diet and exercise
* HbA1C ranged ≥7.0% and ≤10.0%
* Stables doses of drug at least 4 weeks
Exclusion Criteria:
* Newly diagnosed T2DM who will be prescribed insulin for diabetes management
* History of significant weight loss in past 6 months (more than or equal to 5 kg in 1 month)
* Hypersensitivity to any antidiabetic drug
* Type 1 diabetes, a history of ketoacidosis,
* Active liver disease,
* Significant cardiovascular disease,
* A history of malignancy,
* Hematological disorders
* Omarigliptin at any time.
* Any acute condition (acute coronary syndrome, acute stroke etc.)
* Pregnancy and lactation
* eGFR) \<30 mL/min/1.73 m2
* ALT (alanine aminotransferase)-\>2 times the upper limit of the normal
* AST (aspartate aminotransferase)-\>2 times the upper limit of the normal
* TSH-increased or decreased than the normal range
* Hemoglobin \<11 g/dL (male) or \<10 g/dL (female),
* Triglycerides \>600 mg/dL, or
* C-peptide \<0.6 ng/mL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06449235
Study Brief:
Protocol Section:
NCT06449235