NCT07244003 Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control
| NCT ID | NCT07244003 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
| Condition | T2DM (Type 2 Diabetes Mellitus) |
| Study Type | INTERVENTIONAL |
| Enrollment | 430 participants |
| Start Date | 2025-03-29 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 430 participants in total. It began in 2025-03-29 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main objective of this study is to compare the efficacy and safety of the triple combination therapy of Met/SGLT-2i/GLP-1RA or other oral antidiabetic drugs in patients with type 2 diabetes exhibiting poor glycemic control.
Eligibility Criteria
Inclusion Criteria: * Meet the diagnostic criteria for type 2 diabetes (refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition)); -Age: 18-75 years old (including the threshold), male or female; * Body mass index (BMI) ≥20kg/m² ; * 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%); * Volunteer to participate in this study and sign informed consent. Exclusion Criteria: * Patients with type 1 diabetes or other special types of diabetes; * Patients with acute complications of ketoacidosis/hyperglycemic hyperosmolar state/lactic acidosis within 6 months before screening * 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 * Those who received insulin treatment within the previous week * 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 * Liver function impairment at screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 UNL, or total blood bilirubin (TBIL) \> 2 UNL; * Renal impairment at screening: calculated according to the CKD-EPI formula, eGFR≤45 mL/min/1.73m² or serum creatinine≥1.5 UNL; * Patients with a past or family history of medullary thyroid cancer (MTC) and patients with multiple endocrine neoplasia syndrome type 2 (MEN2) * Female subjects who are currently pregnant, breastfeeding, or have a pregnancy plan during the study period * Those who have a history of hypersensitivity reaction to metformin, gapagliflozin, liraglutide injection and other drugs used in research and their excipients or have contraindications to the study drugs; * Those who have participated in other drug clinical trials within 3 months before screening; 21. Subjects who are unable to comply with the protocol under the judgment of the investigator, and those who have other serious physical or psychological diseases that may affect the effectiveness and safety.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07244003 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying T2DM (Type 2 Diabetes Mellitus). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07244003 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07244003 currently recruiting?
Yes, NCT07244003 is actively recruiting participants. Contact the research team at qianxiaofen@eastchinapharm.com for enrollment information.
Where is the NCT07244003 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07244003 clinical trial?
NCT07244003 is sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. The trial plans to enroll 430 participants.
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