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Trial · Interventional

RecruitingPhase 4Registry data

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

Short name MESSAGE

NCTNCT07244003 (opens ClinicalTrials.gov in a new tab)Other idHD-LLPHYJ-LC-1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
430 participants (estimated)
Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
29 Mar 2025
Primary completion
31 Dec 2027 (estimated)
Completion
30 Jun 2028 (estimated)
First posted
24 Nov 2025
Last update posted
24 Nov 2025
Conditions
T2DM (Type 2 Diabetes Mellitus)

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph 4

    MESSAGE

    NCT07244003

    29 Mar 2025 to est. 30 Jun 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • MetforminDrug
  • Triple Therapy of Other Oral Antidiabetic DrugsDrug
  • ganagliflozinDrug
  • liraglutideDrug

Arms2

  • Experimental

    Met+SGLT-2i+GLP-1RA

    Metformin+Ganagliflozin+Liraglutide

  • Active comparator

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The change of HbA1c compared to the baseline

    Time frame · from baseline to week 24

Secondary outcomes(9)

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

    Time frame · week 24

    Registry description

    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)

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

    Time frame · week 24

    Registry description

    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.

  3. The changes of waist circumference and hip circumference compared to the baseline

    Time frame · from baseline to week 24

  4. 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

  5. Changes in systolic and diastolic blood pressure compared to the baseline

    Time frame · from baseline to week 24

  6. The changes in urine albumin-to-creatinine ratio (UACR) compared to the baseline

    Time frame · from baseline to week 24

  7. The changes of body mass compared to the baseline

    Time frame · from baseline to 24 week

  8. The changes of BMI compared to the baseline

    Time frame · from baseline to 24 week

  9. The changes of waist-hip ratio, waist-to-height ratio compared to the baseline

    Time frame · from baseline to 24 week

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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