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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

430 Participants
are divided into 2 treatment groups
Group A: Met+SGLT-2i+GLP-1RAExperimental treatment 3 interventions
Group B: Triple Therapy of Other Oral Antidiabetic DrugsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The change of HbA1c compared to the baseline

Time frame
from baseline to week 24

Secondary outcomes

1

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

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)

Time frame
week 24
2

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

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.

Time frame
week 24
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

Other outcomes

1

The changes in total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, alanine aminotransferase, and aspartate aminotransferase compared to the baseline

Time frame
from baseline to week 120
2

The proportion of participants who received rescue treatment

Time frame
from baseline to week 24

Sponsors and contacts

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