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

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT07244003
Phase
PHASE4
Status
Recruiting
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Conditions

  • T2DM (Type 2 Diabetes Mellitus)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    The dosage of metformin hydrochloride was consistent with baseline.
  • Triple Therapy of Other Oral Antidiabetic Drugs — DRUG
    The dosage of metformin hydrochloride was consistent with baseline. The usage and dosage of other hypoglycemic drugs were referred to their respective instructions.
  • ganagliflozin — DRUG
    Ganagliflozin tablet : 50mg/d.
  • liraglutide — DRUG
    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 Details

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.

Key Dates

Start date
Mar 29, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
430 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

The change of HbA1c compared to the baseline [ Time Frame: from baseline to week 24 ]

Central Contacts

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