Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control
NCT ID: NCT07244003
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
430 participants
INTERVENTIONAL
2025-03-29
2028-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Acarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes
NCT02605772
Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes
NCT05834868
Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin
NCT02280486
Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes
NCT01572740
Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
NCT02057172
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Met+SGLT-2i+GLP-1RA
Metformin+Ganagliflozin+Liraglutide
Metformin
The dosage of metformin hydrochloride was consistent with baseline.
ganagliflozin
Ganagliflozin tablet : 50mg/d.
liraglutide
Liraglutide injection: 0.6 mg/d for the first week, 1.2 mg/d for the second week, and 1.8 mg/d after the third week.
Triple Therapy of Other Oral Antidiabetic Drugs
Building upon the previously stable treatment regimen, the addition of 1-2 oral hypoglycemic agents (excluding SGLT-2 inhibitors and oral GLP-1 receptor agonists) constitutes a triple oral hypoglycemic regimen.
Triple Therapy of Other Oral Antidiabetic Drugs
The dosage of metformin hydrochloride was consistent with baseline. The usage and dosage of other hypoglycemic drugs were referred to their respective instructions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Metformin
The dosage of metformin hydrochloride was consistent with baseline.
Triple Therapy of Other Oral Antidiabetic Drugs
The dosage of metformin hydrochloride was consistent with baseline. The usage and dosage of other hypoglycemic drugs were referred to their respective instructions.
ganagliflozin
Ganagliflozin tablet : 50mg/d.
liraglutide
Liraglutide injection: 0.6 mg/d for the first week, 1.2 mg/d for the second week, and 1.8 mg/d after the third week.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HD-LLPHYJ-LC-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.