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NCT07244003·Phase 4·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 4

Enrollment

430

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Metformin

The dosage of metformin hydrochloride was consistent with baseline.

DRUG

Triple Therapy of Other Oral Antidiabetic Drugs

The dosage of metformin hydrochloride was consistent with baseline. The usage and dosage of other hypoglycemic drugs were referred to their respective instructions.

DRUG

ganagliflozin

Ganagliflozin tablet : 50mg/d.

DRUG

liraglutide

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.

Timeline

From registration to results.

  1. First posted

    Nov 24, 2025

  2. Study start

    Mar 29, 2025

  3. Primary completion

    Dec 31, 2027

  4. Study completion

    Jun 30, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Nov 24, 2025

Outcomes

What the study measures.

Primary outcomes

The change of HbA1c compared to the baseline

Time frame · from baseline to week 24

Secondary outcomes

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

Time frame · week 24

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)

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

Time frame · week 24

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.

The changes of waist circumference and hip circumference compared to the baseline

Time frame · from baseline to week 24

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

Changes in systolic and diastolic blood pressure compared to the baseline

Time frame · from baseline to week 24

The changes in urine albumin-to-creatinine ratio (UACR) compared to the baseline

Time frame · from baseline to week 24

The changes of body mass compared to the baseline

Time frame · from baseline to 24 week

The changes of BMI compared to the baseline

Time frame · from baseline to 24 week

The changes of waist-hip ratio, waist-to-height ratio compared to the baseline

Time frame · from baseline to 24 week

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Liraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.