A Study of BGM0504 in Participants with Type 2 Diabetes
ConditionType 2 Diabetes Mellitus (T2DM)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBrightGene Bio-Medical Technology Co., Ltd.
About this trial
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
Eligibility criteria
Qualifiers
■ 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;
Disqualifiers
■ 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;
Trial design
Treatments tested in this trial
- Drug: 5 mg BGM0504 Administered SC
- Drug:10 mg BGM0504 Administered SC
- Drug: Semaglutide Administered SC
Treatment groups
537 Participants
are divided into 3 treatment groupsSponsors and collaborators
BrightGene Bio-Medical Technology Co., Ltd.
Lead sponsor
BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
Collaborator
Source ClinicalTrials.gov