A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

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

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BGM0504 for people with type 2 diabetes who are having difficulty controlling their blood sugar levels through diet and exercise alone. The trial will last for 32 weeks, with a follow-up period of 52 weeks, and aims to see how effective and safe BGM0504 is compared to a placebo (a treatment that looks like the real medication but has no active ingredients). It's important to know that this study is taking place in multiple centers and is currently recruiting participants.

To be eligible for this trial, participants must be diagnosed with type 2 diabetes and have a specific body weight measurement (BMI of at least 23). They should also have their blood sugar level, measured by a test called HbA1c, between 7.5% and 11.0%. Participants can expect to receive either the BGM0504 injection or a placebo, and their health will be monitored throughout the study. This could be a great opportunity for those struggling with blood sugar control to contribute to important research and potentially improve their treatment options.

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Eligibility criteria

• Inclusion Criteria:
• • ☑ Have been diagnosed with type 2 diabetes mellitus (T2DM);
• • 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%；
• • Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L.
• 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.