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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Metformin
  • Triple Therapy of Other Oral Antidiabetic Drugs
  • ganagliflozin
  • liraglutide

Treatment groups

430 Participants
are divided into 2 treatment groups