Type 2 diabetes mellitus
Conditions
Interventions
Metformin + Empagliflozin:N/A
Metformin + Empagliflozin + Trelagliptin:N/A
Sponsors
Zhengzhou Central Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients with type 2 diabetes mellitus (T2DM) with a disease duration of >=3 months, aged between 65 and 80 years (inclusive), and with a body mass index (BMI) > 18.5 kg/m^2 and =7.0% and =1000 mg/day) and empagliflozin (either as monotherapy or in combination) for at least 6 weeks. 4. Willing to participate in this clinical study and having provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who are allergic to trelagliptin and/or its inactive ingredients, metformin, empagliflozin, or have a history of severe allergic diseases, or have contraindications to the study medications. 2. Subjects who have used any antidiabetic medications other than empagliflozin and metformin within the past month. 3. Subjects who have experienced acute coronary syndrome, stroke, or transient ischemic attack within the past 3 months. 4. Subjects with active liver disease or liver function impairment [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) >=3 times the upper limit of normal (ULN)]. 5. Subjects with severe hypertriglyceridemia (triglycerides [TG] >5.6 mmol/L). 6. Subjects with a history of acute pancreatitis. 7. Subjects with clinically significant abnormalities on electrocardiogram (ECG), such as QTc interval prolongation >500 ms. 8. Subjects with an estimated glomerular filtration rate (eGFR) 180 mmHg or diastolic blood pressure (DBP) >110 mmHg. 11. Subjects who have experienced diabetic ketoacidosis, lactic acidosis, or hyperosmolar hyperglycemic state or precursor coma within the past 6 months. 12. Subjects with psychiatric disorders or cognitive impairments that may interfere with their ability to comply with the study protocol. 13. Subjects who have participated in another clinical trial within the past 3 months. 14. Subjects with a history of recurrent urinary or genital infections. 15. Subjects whom the investigator deems unsuitable for participation in the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Low-density lipoprotein;Fasting blood glucose;Triglycerides;Glomerular Filtration Rate;HbA1c target achievement rate;Body weight;Total cholesterol;Blood pressure;High-density lipoprotein;2h-PG;Adverse events and adverse reactions; | — |
Countries
China
Contacts
Public ContactKang Zhiqiang
Zhengzhou Central Hospital
Outcome results
None listed