A Study of BGM0504 in Participants with Type 2 Diabetes

Официальное название

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly As Add-on Therapy to Metformin And/or Sulfonylureas in Patients with Type 2 Diabetes

Обзор

This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes

Вмешательства

• Препарат Drug: 5 mg BGM0504 Administered SC
  Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
• Препарат Drug:10 mg BGM0504 Administered SC
  Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.
• Препарат Drug: Semaglutide Administered SC
  Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week

Первичные конечные точки

• Change From Baseline in Hemoglobin A1c (HbA1c) [Срок оценки: Week 0 to Week 32]

Вторичные конечные точки (5)

• Change From Baseline in Body Weight [Срок оценки: Week 0 to Week 52]
• Change From Baseline in Hemoglobin A1c (HbA1c) [Срок оценки: Week 0 to Week 52]
• Percentage of Participants With HbA1c Target Value of <7% [Срок оценки: Week 0 to Week 52]
• Percentage of Participants With HbA1c Target Value of <5.7% [Срок оценки: Week 0 to Week 52]
• Change From Baseline in Fasting Serum Glucose [Срок оценки: Week 0 to Week 52]

Критерии участия

Критерии включения

• ■ Have been diagnosed with type 2 diabetes mellitus (T2DM);

• Metformin is used in screening : 1) After used stable-dose metformin (≥1500 mg/day) or maximum tolerated (< 1500mg but≥1000mg daily) for 8 weeks before screening； 2)Metformin treatment dose <1500mg/day at Screening and have not reached the maximum tolerated dose ；3) Metformin combined with daily fixed-dose sulfonylureas (minimum therapeutic dose on the drug label) had been stable for ≥8 weeks when entering the induction period.
• Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
• Be of stable weight (± 5%) for at least 3 months before screening;
• Have HbA1c between ≥7.5% and ≤11.0%；

Критерии исключения

• ■ Previous diagnosis of type 1 diabetes, special type diabetes;

• There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).
• Have had chronic or acute pancreatitis any time prior to study entry;
• Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;
• Mentally incapacitated or speech-impaired;
• Suspected or confirmed history of alcohol or drug abuse;
• Pregnant or lactating woman;
• The investigator considers that there are any other conditions that make it inappropriate to participate in this study.

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

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT06716216 · BGM0504-Ⅲ -T2DM-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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