type 2 diabetic patie
Conditions
Interventions
experimental group:Experimental group: metformin hydrochloride tablet + proline plus aglipzin tablet + Liraglutide injection
Metformin hydrochloride tablets (0.5g) : The dosage of metformin hydrochlor
Control group:Control group: other three oral hypoglycemic regimen
On the basis of the previous stable treatment regimen, 1-2 oral hypoglycemic agents (except SGLT-2i and oral GLP-1RA drugs) were adde
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: 1. Meet the diagnostic criteria for type 2 diabetes (refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition)); 2. Age: 18-75 years old (including the threshold), male or female; 3. Body mass index (BMI) >=20kg/m^2; 4. Patients who took 1000mg or more of metformin in combination with or without another oral hypoglycemic agent (except SGLT-2i and oral GLP-1RA) for at least 8 weeks before screening and had poor blood glucose control (centralized detection of HBA1C >=7.5% and<=11.0%); 5. Volunteer to participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes or other special types of diabetes; 2. Patients with acute complications of ketoacidosis/hyperglycemic hyperosmolar state/lactic acidosis within 6 months before screening; 3. Those who have used GLP-1RA and SGLT-2i drugs within 12 weeks before screening, or have used GLP-1RA and SGLT-2i drugs in the past and discontinued due to poor efficacy; 4. Those who have received long-term insulin therapy (more than 14 consecutive days) within 3 months before screening, or are receiving insulin therapy at the time of screening, the last time of short-term insulin treatment should be > 1 week from the screening date; 5. Those who have received traditional drugs (such as traditional Chinese medicine preparations) with known/pending antihyperglycemic effects within 3 months before screening; 6. Those who have a history of chronic or acute pancreatitis before screening, or have clinical manifestations of pancreatitis at the time of screening, or fasting triglycerides > 5.7 mmol/L during the screening period; 7. Patients with severe infection (systemic infection with organ dysfunction, such as sepsis, meningitis, pneumonia, osteomyelitis, cellulitis, gastroenteritis with dehydration, urinary tract infection with systemic reactions such as fever, and respiratory virus infection complicated by hypoxia such as bronchiolitis, etc.) or genitourinary infection within 1 month before screening; 8. Liver function impairment at screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal, or total blood bilirubin (TBIL) > 2 times the upper limit of normal; 9. Those who have a history of chronic or acute cholecystitis and gallstones before screening (except for subjects who have undergone cholecystectomy and are in stable condition after surgery); 10. Renal impairment at screening: calculated according to the CKD-EPI formula, eGFR=1.5 times the upper limit of normal; 11. Patients with uncontrolled or poorly treated hypertension (systolic blood pressure>=160mmHg and/or diastolic blood pressure >=100 mmHg) or hypotension (systolic blood pressure< 90 mmHg and/or diastolic blood pressure) at screening<60 mmHg); 12. Those who have severe kidney stones (causing serious complications such as urinary tract obstruction, renal failure, uremia, etc.) or have had severe recurrent kidney stones at the time of screening; 13. Patients with severe heart disease, such as cardiac insufficiency (New York cardiac function grade III. or above), acute coronary syndrome, and old myocardial infarction; 14. Patients with a past or family history of medullary thyroid cancer (MTC) and patients with multiple endocrine neoplasia syndrome type 2 (MEN2); 15. Female subjects who are currently pregnant, breastfeeding, or have a pregnancy plan during the study period; 16. Grade 3 hypoglycemia events (requiring help from others for treatment and accompanied by conscious and/or physical changes, but no specific blood glucose boundaries) or frequent hypoglycemia (more than 3 blood glucose occurrences within a month) within 6 months prior to screening<3.9 mmol/L or hypoglycemia symptoms); 17. Those who have a history of severe gastrointestinal diseases or surgery, including gastric heart syndrome, severe hernia, intestinal obstruction, gastroparesis, intestinal ulcer, gastrointestinal anastomosis, bowel resection, bariatric surgery or band surgery; 18. Those who have received o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| urinary albumin;urine creatinine;weight;waistline;hip circumference;blood fat;blood pressure; | — |
Countries
China
Contacts
Public ContactLiu Ming
Tianjin Medical University General Hospital
Outcome results
None listed