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

Hangzhou Zhongmei Huadong Pharmaceutical

Status and phase: Enrolling; Phase 4

Conditions: T2DM (Type 2 Diabetes Mellitus)

Treatments: Drug: Metformin; Drug: liraglutide; Drug: ganagliflozin; Drug: Triple Therapy of Other Oral Antidiabetic Drugs

Study type: Interventional

Funder types: Industry

Identifiers

NCT07244003

HD-LLPHYJ-LC-1

Details and patient eligibility

About

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.

Enrollment: 430 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 2 patient groups

Met+SGLT-2i+GLP-1RA

Experimental group

Description:

Metformin+Ganagliflozin+Liraglutide

Treatment:

Drug: liraglutide

Drug: ganagliflozin

Drug: Metformin

Triple Therapy of Other Oral Antidiabetic Drugs

Active Comparator group

Description:

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.

Treatment:

Drug: Triple Therapy of Other Oral Antidiabetic Drugs