A Study of BGM0504 in Participants with Type 2 Diabetes

Launched by BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO., LTD. · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BGM0504 to see how well it works and how safe it is for people with type 2 diabetes, compared to another medication called semaglutide. The trial involves patients who are already taking metformin and/or sulfonylureas, which are common treatments for managing blood sugar levels. It is taking place in China and is currently looking for participants aged between 18 and 75 years who meet certain health criteria.

To be eligible, participants must have a confirmed diagnosis of type 2 diabetes and have been on a stable dose of metformin for at least 8 weeks. They should also have a body mass index (BMI) of at least 23 and their blood sugar levels (measured as HbA1c) need to fall between 7.5% and 11%. Participants can expect regular check-ups and monitoring throughout the study. It’s important to note that people with certain health conditions, such as a history of type 1 diabetes or pancreatitis, or those who are pregnant or breastfeeding, cannot take part in this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ■ 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%；
• Exclusion Criteria:
• • ■ 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.