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Recruiting NCT07244003

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

Phase IV Interventional T2DM (Type 2 Diabetes Mellitus)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Metformin, Triple Therapy of Other Oral Antidiabetic Drugs, ganagliflozin, liraglutide.
Who it may be relevant to
Registry conditions: T2DM (Type 2 Diabetes Mellitus). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • The change of HbA1c compared to the baseline [Time frame: from baseline to week 24]
Secondary outcome measures (9)
  • The proportion of participants achieving HbA1c, blood pressure, and cholesterol targets [Time frame: week 24]
  • The proportion of patients achieving HbA1c target without hypoglycemia or weight gainning [Time frame: week 24]
  • 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 criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University General Hospital — Tianjin

Identifiers

NCT: NCT07244003 · HD-LLPHYJ-LC-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗