T2DM (Type 2 Diabetes Mellitus)Phase 4MESSAGENCT07244003
Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control
A Phase 4 study testing Metformin, Triple Therapy of Other Oral Antidiabetic Drugs and ganagliflozin in people with T2DM (Type 2 Diabetes Mellitus), run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- Metformin, Triple Therapy of Other Oral Antidiabetic Drugs and ganagliflozin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2025to 30 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Ming Liu, +86 183 2201 7516, mingliu@tmu.edu.cn
About this study
Official title: 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
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)
- Being tested
- Metformin, Triple Therapy of Other Oral Antidiabetic Drugs, ganagliflozin, liraglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
The dosage of metformin hydrochloride was consistent with baseline.
Triple Therapy of Other Oral Antidiabetic DrugsDrug
The dosage of metformin hydrochloride was consistent with baseline. The usage and dosage of other hypoglycemic drugs were referred to their respective instructions.
ganagliflozinDrug
Ganagliflozin tablet : 50mg/d.
liraglutideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Met+SGLT-2i+GLP-1RA | Experimental | Metformin+Ganagliflozin+Liraglutide Receives: 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. Receives: Drug: Triple Therapy of Other Oral Antidiabetic Drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of HbA1c compared to the baseline
Measured: from baseline to week 24
Secondary outcomes (9)
The proportion of participants achieving HbA1c, blood pressure, and cholesterol targets
HbA1c ≤ 7.0% Blood pressure < 130/80 mmHg For subjects without ASCVD, LDL-C < 2.6 mmol/L; for subjects with ASCVD, LDL-C < 1.8 mmol/L (< 70 mg/dL)
Measured: week 24
The proportion of patients achieving HbA1c target without hypoglycemia or weight gainning
HbA1c target ≤ 7.0% The definition of hypoglycemia is: Blood glucose < 70 mg/dL ( < 3.9 mmol/L), regardless of whether there are symptoms of hypoglycemia.
Measured: week 24
The changes of waist circumference and hip circumference compared to the baseline
Measured: 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
Measured: from baseline to week 24
Changes in systolic and diastolic blood pressure compared to the baseline
Measured: from baseline to week 24
The changes in urine albumin-to-creatinine ratio (UACR) compared to the baseline
Measured: from baseline to week 24
The changes of body mass compared to the baseline
Measured: from baseline to 24 week
The changes of BMI compared to the baseline
Measured: from baseline to 24 week
The changes of waist-hip ratio, waist-to-height ratio compared to the baseline
Measured: from baseline to 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start29 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244003
- Sponsor's protocol ID
- HD-LLPHYJ-LC-1
- Acronym
- MESSAGE
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07244003
- Acronym / sponsor ID
- MESSAGE / HD-LLPHYJ-LC-1
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Met+SGLT-2i+GLP-1RA | Experimental | Drug: Metformin, Drug: ganagliflozin, Drug: liraglutideMetformin+Ganagliflozin+Liraglutide |
| Triple Therapy of Other Oral Antidiabetic Drugs | Active comparator | Drug: Triple Therapy of Other Oral Antidiabetic DrugsBuilding 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminThe dosage of metformin hydrochloride was consistent with baseline. | Drug | Met+SGLT-2i+GLP-1RA |
| Triple Therapy of Other Oral Antidiabetic DrugsThe dosage of metformin hydrochloride was consistent with baseline. The usage and dosage of other hypoglycemic drugs were referred to their respective instructions. | Drug | Triple Therapy of Other Oral Antidiabetic Drugs |
| ganagliflozinGanagliflozin tablet : 50mg/d. | Drug | Met+SGLT-2i+GLP-1RA |
| liraglutideLiraglutide 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. | Drug | Met+SGLT-2i+GLP-1RA |
Primary outcome
The change of HbA1c compared to the baseline
Time frame: from baseline to week 24
9 secondary outcomes
The proportion of participants achieving HbA1c, blood pressure, and cholesterol targets
Time frame: week 24
The proportion of patients achieving HbA1c target without hypoglycemia or weight gainning
Time frame: week 24
The changes of waist circumference and hip circumference compared to the baseline
Time frame: 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
Time frame: from baseline to week 24
Changes in systolic and diastolic blood pressure compared to the baseline
Time frame: from baseline to week 24
The changes in urine albumin-to-creatinine ratio (UACR) compared to the baseline
Time frame: from baseline to week 24
The changes of body mass compared to the baseline
Time frame: from baseline to 24 week
The changes of BMI compared to the baseline
Time frame: from baseline to 24 week
The changes of waist-hip ratio, waist-to-height ratio compared to the baseline
Time frame: from baseline to 24 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin, Triple Therapy of Other Oral Antidiabetic Drugs and ganagliflozin in people with T2DM (Type 2 Diabetes Mellitus), run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaofen Qian (+86-0571-89908582, qianxiaofen@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of HbA1c compared to the baseline (time frame: from baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.