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Multicenter cohort research evaluating the effectiveness and safety of SGLT-2 inhibitor and DPP-4 inhibitor and metformin combined therapy in type 2 diabetes mellitus based on real-world study

Multicenter cohort research evaluating the effectiveness and safety of SGLT-2 inhibitor and DPP-4 inhibitor and metformin combined therapy in type 2 diabetes mellitus based on real-world study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089642
Enrollment
Unknown
Registered
2024-09-12
Start date
2024-09-30
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Group A (Proline hengagliflozin 10 mg once a day, repagliptin phosphate 100 mg once a day, metformin hydrochloride tablets 500 mg twice a day):None
Group B (Proline hengagliflozin 10 mg once a day, metformin hydrochloride tablets 500 mg twice a day):None
Group C (Repagliptin phosphate 100 mg once a day, metformin hydrochloride tablets 500 mg twice a day):None

Sponsors

Guangdong Provincial Hospital of Integrative Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the diagnostic criteria for type 2 diabetes mellitus in 1999; (2) Fasting blood glucose (fingertip/vein) =7mmol/L or glycosylated hemoglobin (HbA1c) =7%, age = 18 years old, male or female; (3) Able to understand the content and methods of this study and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Diabetic ketosis or ketoacidosis, diabetic hyperosmolar state, diabetic lactic acidosis and other acute diabetic complications or severe chronic diabetic complications; (2) Those with a history of recurrent urinary tract infections and/or genital infections in the past six months; (3) Severe trauma or acute infection that may affect blood glucose control within 4 weeks; (4) Those who have negligent compensated heart failure (NYHA class IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, cardiac surgery or revascularization (including coronary artery bypass grafting or percutaneous coronary intervention) within 6 months; (5) Have obvious hematologic diseases (such as aplastic anemia, myelodysplastic syndrome) or any disease that causes hemolysis or red blood cell instability (such as malaria, hemolytic anemia); (6) Patients with severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery); (7) uncontrolled hyperthyroidism; (8) Those who have psychiatric or neurological diseases, are unwilling to communicate or are unable to fully understand and cooperate; (9) Pregnant or lactating females; (10) There is any laboratory test index that meets the following criteria: 1) alanine aminotransferase > 3.0 times the upper limit of normal (ULN) and/or aspartate aminotransferase > 3.0 times ULN and/or total bilirubin > 2.0 times ULN; 2) estimated glomerular filtration rate (eGFR) 3.0 times ULN. (11) In addition to the above, patients judged by the investigator to be unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Countries

China

Contacts

Public ContactTang Qizhi

Guangdong Provincial Hospital of Integrative Medicine

13129363728@163.com+86 131 2936 3728

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026