Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control

NCT07244003 | Recruiting Phase 4

• 1 other identifier: HD-LLPHYJ-LC-1
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

• The change of HbA1c compared to the baseline

  from baseline to week 24

Secondary Outcomes (9)

• The proportion of participants achieving HbA1c, blood pressure, and cholesterol targets

  week 24

• The proportion of patients achieving HbA1c target without hypoglycemia or weight gainning

  week 24

• The changes of waist circumference and hip circumference compared to the baseline

  from baseline to week 24

• The changes of fasting blood glucose, 2-hour post-meal blood glucose, fasting glucagon, fasting insulin, insulin resistance index (HOMA-IR) compared to the baseline

  from baseline to week 24

• Changes in systolic and diastolic blood pressure compared to the baseline

  from baseline to week 24

Other Outcomes (2)

• The changes in total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, alanine aminotransferase, and aspartate aminotransferase compared to the baseline

  from baseline to week 120

• The proportion of participants who received rescue treatment

  from baseline to week 24

Study Arms (2)

Met+SGLT-2i+GLP-1RA

EXPERIMENTAL

Metformin+Ganagliflozin+Liraglutide

Drug: Metformin; Drug: ganagliflozin; Drug: liraglutide

Triple Therapy of Other Oral Antidiabetic Drugs

ACTIVE COMPARATOR

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.

Drug: Triple Therapy of Other Oral Antidiabetic Drugs

Interventions

Metformin DRUG

The dosage of metformin hydrochloride was consistent with baseline.

Met+SGLT-2i+GLP-1RA

Triple Therapy of Other Oral Antidiabetic Drugs DRUG

The dosage of metformin hydrochloride was consistent with baseline. The usage and dosage of other hypoglycemic drugs were referred to their respective instructions.

Triple Therapy of Other Oral Antidiabetic Drugs

ganagliflozin DRUG

Ganagliflozin tablet : 50mg/d.

Met+SGLT-2i+GLP-1RA

liraglutide DRUG

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.

Met+SGLT-2i+GLP-1RA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Xiaofen Qian

CONTACT

+86-0571-89908582; qianxiaofen@eastchinapharm.com

Wanting Zhang

CONTACT

+86-0571-89905517; zhangwanting@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 24, 2025
• Study Start: March 29, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CN (1)