Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT07244003

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

Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-11-24

430

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with type 2 diabetes according to Chinese guidelines (2020 edition)
  • Age between 18 and 75 years, male or female
  • Body mass index (BMI) of 20 kg/m² or higher
  • Taking 1000 mg or more of metformin daily, with or without other oral diabetes drugs (excluding SGLT-2 inhibitors and GLP-1 receptor agonists), for at least 8 weeks before screening
  • Poor blood sugar control with HbA1c between 7.5% and 11.0%
  • Willing to participate and able to sign informed consent
Not Eligible

You will not qualify if you...

  • Diagnosed with type 1 diabetes or other special diabetes types
  • Had ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis within 6 months before screening
  • Used GLP-1 receptor agonists or SGLT-2 inhibitors within 12 weeks before screening, or previously stopped these drugs due to poor effect
  • Received insulin treatment within 1 week before screening
  • History or current signs of pancreatitis, or fasting triglycerides above 5.7 mmol/L during screening
  • Liver function tests showing ALT or AST above 3 times the upper normal limit, or bilirubin above 2 times the upper normal limit
  • Kidney function impairment with eGFR below 45 mL/min/1.73m² or serum creatinine above 1.5 times the upper normal limit
  • Past or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2
  • Pregnant, breastfeeding, or planning pregnancy during the study
  • Allergic or intolerant to metformin, ganagliflozin, liraglutide, or related ingredients
  • Participated in another drug trial within 3 months before screening
  • Unable to follow the study protocol or having serious physical or mental conditions affecting safety or effectiveness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

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Research Team

X

Xiaofen Qian

CONTACT

W

Wanting Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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