Metformin plus SGLT‑2 inhibitor and GLP‑1 receptor agonist triple therapy for poorly controlled type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 4 interventional study comparing a triple combination of metformin, an SGLT‑2 inhibitor, and a GLP‑1 receptor agonist with other oral antidiabetic regimens in adults with type 2 diabetes and inadequate glycemic control. Eligible participants are adults (18–75 years) on at least 1000 mg metformin for ≥8 weeks with a centralized HbA1c between 7.5% and 11.0% and BMI ≥20 kg/m2. Those meeting criteria will receive either the triple therapy (examples include canagliflozin and liraglutide added to metformin) or comparator oral therapies and will be followed for efficacy and safety outcomes. The trial is sponsored by Hangzhou Zhongmei Huadong Pharmaceutical and conducted at Tianjin Medical University General Hospital.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University General Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaofen Qian
• Email: qianxiaofen@eastchinapharm.com
• Phone: +86-0571-89908582

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Anti-inflammatory Diet for Type 2 Diabetes

  This study tests whether an anti-inflammatory diet can lower inflammation and improve blood sugar control in adults with type 2 diabetes.

  Recruiting Anhui Medical University · Hefei, Anhui · NCT07656805

• Chiglitazar added to SGLT-2 inhibitors for type 2 diabetes

  This real-world registry tests whether adding chiglitazar to ongoing SGLT-2 inhibitor therapy helps adults with type 2 diabetes improve blood sugar control and supports heart, kidney, and liver safety.

  Recruiting at 2 sites Chipscreen Biosciences, Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07580638

• Pulsendo for Type 2 Diabetes and fatty liver disease in adults

  This study tests the pulsENDO procedure in adults with type 2 diabetes who still have high blood sugar despite meds, to see if it helps their diabetes and fatty liver disease.

  Recruiting Chinese University of Hong Kong · Shatin · NCT07390422

• Semaglutide's effects on inflammation and blood vessel health in type 2 diabetes

  This trial will test whether adding semaglutide to standard treatment reduces inflammation and improves blood vessel function in adults with type 2 diabetes who do not have diagnosed heart disease.

  Recruiting at 2 sites Phase 4 Federico II University · Caserta, Caserta and 1 other locations · NCT07314684

• Chiglitazar for MASH and Type 2 Diabetes

  This trial tests whether chiglitazar can help adults with MASH and type 2 diabetes when added to standard vitamins and liver-supporting therapy.

  Recruiting Phase 2 Shanghai Jiao Tong University School of Medicine · Beijing, Beijing Municipality and 16 other locations · NCT07303803

• Assessing ezefeno for patients with dyslipidemia and type 2 diabetes

  This study is testing if a new combination treatment called ezefeno can help people with high cholesterol and type 2 diabetes lower their cholesterol levels and reduce heart risks when other medications aren't enough.

  Recruiting Korea University Anam Hospital · Seoul · NCT06293417

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.