Actively Recruiting
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
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-11-24
430
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of a triple combination therapy using Metformin, an SGLT-2 inhibitor (Ganagliflozin), and a GLP-1 receptor agonist (Liraglutide) compared to other oral antidiabetic drugs in adults with type 2 diabetes who have poor blood sugar control. This phase 4 trial focuses on patients whose blood sugar levels remain high despite previous treatments. The aim is to determine how well these therapies work and how safe they are for this group. The trial compares two groups: one receiving Metformin combined with Ganagliflozin and Liraglutide, and the other continuing a triple oral therapy with other antidiabetic drugs excluding SGLT-2 inhibitors and oral GLP-1 receptor agonists. Dosing follows prior stable regimens with specific dosing for Ganagliflozin (50 mg daily) and Liraglutide (starting at 0.6 mg daily and increasing over three weeks). Treatment lasts for 24 weeks. Participants will have their blood sugar control monitored through HbA1c measurements at baseline and after 24 weeks, along with other health indicators such as blood pressure, cholesterol, waist and hip size, fasting glucose, insulin resistance, urine tests, body mass index, and waist-to-height ratio. Safety and treatment effects will be assessed throughout the study, with all outcomes measured at week 24. The study runs until mid-2028.
CONDITIONS
Brief Title
Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes according to Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition)
- Age between 18 and 75 years, male or female
- Body mass index (BMI) of 20 kg/m² or higher
- Taking at least 1000 mg of metformin with or without other oral hypoglycemic agents (excluding SGLT-2 inhibitors and oral GLP-1 receptor agonists) for at least 8 weeks before screening
- Poor blood glucose control with HbA1c between 7.5% and 11.0%
- Willing to participate and sign informed consent
You will not qualify if you...
- Diagnosis of type 1 diabetes or other special types of diabetes
- Acute ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis within 6 months before screening
- Use of GLP-1 receptor agonists or SGLT-2 inhibitors within 12 weeks before screening, or prior use discontinued due to poor efficacy
- Insulin treatment within the past week
- History of chronic or acute pancreatitis, current clinical pancreatitis symptoms, or fasting triglycerides over 5.7 mmol/L at screening
- Liver function impairment with ALT or AST over 3 times the upper normal limit or total bilirubin over 2 times the upper normal limit
- Renal impairment with eGFR less than 45 mL/min/1.73m² or serum creatinine over 1.5 times the upper normal limit
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2
- Pregnant, breastfeeding, or planning pregnancy during the study
- History of allergic reactions to metformin, ganagliflozin, liraglutide, or related excipients
- Participation in other drug clinical trials within 3 months before screening
- Inability to comply with the study protocol or presence of serious physical or psychological conditions affecting safety or effectiveness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive assigned drug therapies including metformin combined with ganagliflozin and liraglutide or other oral antidiabetic drugs to manage blood glucose levels.
Regular visits during the 24-week treatment period
Trial Site Locations
Total: 1 location
1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
X
Xiaofen Qian
W
Wanting Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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