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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Metformin
  The dosage of metformin hydrochloride was consistent with baseline.
• Препарат 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.
• Препарат ganagliflozin
  Ganagliflozin tablet : 50mg/d.
• Препарат 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.

Первичные конечные точки

• The change of HbA1c compared to the baseline [Срок оценки: from baseline to week 24]

Вторичные конечные точки (9)

• The proportion of participants achieving HbA1c, blood pressure, and cholesterol targets [Срок оценки: week 24]
• The proportion of patients achieving HbA1c target without hypoglycemia or weight gainning [Срок оценки: week 24]
• The changes of waist circumference and hip circumference compared to the baseline [Срок оценки: 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 [Срок оценки: from baseline to week 24]
• Changes in systolic and diastolic blood pressure compared to the baseline [Срок оценки: from baseline to week 24]
• The changes in urine albumin-to-creatinine ratio (UACR) compared to the baseline [Срок оценки: from baseline to week 24]
• The changes of body mass compared to the baseline [Срок оценки: from baseline to 24 week]
• The changes of BMI compared to the baseline [Срок оценки: from baseline to 24 week]
• The changes of waist-hip ratio, waist-to-height ratio compared to the baseline [Срок оценки: from baseline to 24 week]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Medical University General Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07244003 · HD-LLPHYJ-LC-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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