Phase
Condition
Diabetes Mellitus, Type 2
Diabetes Prevention
Diabetes And Hypertension
Treatment
Drug: Semaglutide Administered SC
Drug:10 mg BGM0504 Administered SC
Drug: 5 mg BGM0504 Administered SC
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
■ Have been diagnosed with type 2 diabetes mellitus (T2DM);
Metformin is used in screening : 1) After used stable-dose metformin (≥1500mg/day) or maximum tolerated (< 1500mg but≥1000mg daily) for 8 weeks beforescreening; 2)Metformin treatment dose <1500mg/day at Screening and have notreached the maximum tolerated dose ;3) Metformin combined with daily fixed-dosesulfonylureas (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
Exclusion Criteria:
■ Previous diagnosis of type 1 diabetes, special type diabetes;
There are malignant tumors within 5 years before screening, or patients are inlatent of clinical malignant tumors (except patients with skin basal cellcarcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostatecarcinoma in situ or papillary thyroid carcinoma who have no recurrence aftersurgery).
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), orallergy 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 itinappropriate to participate in this study.
Study Design
Connect with a study center
Peking University People's Hospital
Beijing, Beijing 100044
ChinaActive - Recruiting
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