Type 2 Diabetes (T2DM)
Conditions
Brief summary
This trial is conducted in China. The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise. Over 52 weeks of once weekly treatment, efficacy and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.
Interventions
DRUGBGM0504
Administered as a subcutaneous injection once weekly for 52 weeks.
DRUGsemaglutide
Administered as a subcutaneous injection once weekly for 52 weeks.
Sponsors
BrightGene Bio-Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ○ Have been diagnosed with type 2 diabetes mellitus (T2DM)， disease duration ≤5 years, treatment naïve with ≥8 weeks diet/exercise, or off antidiabetic therapy ≥8 weeks prior to screening. * BMI 28.0-35.0 kg/m² at screening, with stable weight (±5%) for 3 months prior to screening. * Have HbA1c between ≥7.5% and ≤10.5% at screening. * FPG ≤15.0 mmol/L at screening. * If hypertensive: SBP \<180 mmHg and DBP \<110 mmHg at enrollment, on stable (≥2 weeks) ≤2 antihypertensives, or no medication with diet/exercise ≥4 weeks. * Willing to comply with protocol, use effective contraception, and provide informed consent.
Exclusion criteria
* ● Previous diagnosis of type 1 diabetes, special type diabetes or gestational diabetes. * Prior use of antidiabetics or systemic glucocorticoids within 8 weeks, prior GLP-1/GIP/GCG receptor agonists with intolerance/poor response, or weight-loss drugs within 3 months. * History of acute/chronic pancreatitis. * Medullary thyroid carcinoma, MEN 2A/2B, or family history. * Malignancy within 5 years (except treated BCC/SCC, cervical/PSC/thyroid papillary carcinoma in situ with no recurrence). * Severe cardiac conditions within 6 months: NYHA III/IV HF, unstable angina, MI, CABG/stent, severe arrhythmias. * Hemorrhagic or ischemic stroke within 6 months. * Severe renal disease or eGFR ≤60 mL/min/1.73 m² (CKD-EPI). * Pregnant or lactating woman. * Prior clinical trial participation with investigational drug or device within 3 months. * Other situations that are deemed as inappropriate for participation by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline | Week 52 | Composite endpoint assessing both glycemic control and weight loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving Diabetes Remission | Week 64 (12 weeks off treatment) | Defined as HbA1c \< 6.5% without use of glucose-lowering medications. |
| Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥10% from Baseline | Weeks 12, 24, 36, 44 | Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds. |
| Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥ 5%, or 15% from Baseline | Weeks 12, 24, 36, 44, 52 | Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds. |
| Proportion of Participants Achieving HbA1c Targets (< 7.0%, ≤ 6.5%, < 5.7%) | Weeks 12, 24, 36, 44, 52 | Glycemic control assessed at each visit. |
| Proportion of Participants Achieving HbA1c ≤ 6.5% or < 5.7% with Weight Reduction ≥ 5%, 10%, or 15% from Baseline | Weeks 12, 24, 36, 44, 52 | Composite endpoint assessing stricter glycemic targets combined with weight loss. |
| Proportion of Participants Achieving Glycemic and Weight Targets at 12 Weeks Off Treatment | Week 64 | Composite of HbA1c \< 5.7% or \< 6.5% with weight reduction ≥ 5% or ≥ 10%, assessing durability of response after treatment withdrawal. |
| Change from Baseline in HbA1c | Weeks 12, 24, 36, 44, 52 | Absolute change in glycated hemoglobin from baseline. |
| Change from Baseline in Fasting Plasma Glucose (FPG) | Weeks 12, 24, 36, 44, 52 | Absolute change in fasting glucose from baseline. |
| Change from Baseline in 2-Hour Postprandial Glucose | Week 52 | Glucose measured 2 hours after a standard meal, absolute change from baseline. |
| Change from Baseline in Body Weight | Weeks 12, 24, 36, 44, 52 | Absolute and percentage change in body weight |
| Change from Baseline in BMI | Weeks 12, 24, 36, 44, 52 | Absolute and percentage change in BMI (kg/m²). |
| Change from Baseline in Waist Circumference and Hip Circumference | Weeks 12, 24, 36, 44, 52 | Absolute change in waist and hip circumference from baseline. |
| Proportion of Participants Achieving Weight Reduction ≥ 5%, 10%, 15%, and 20% from Baseline | Weeks 12, 24, 36, 44, 52 | Categorical weight loss responders at multiple thresholds. |
| Percentage Change from Baseline in Lipid Profile (TC, TG, LDL-C, HDL-C) | Weeks 12, 24, 36, 44, 52 | Percentage change in total cholesterol, triglycerides, LDL-C, and HDL-C from baseline. |
| Change from Baseline in Systolic and Diastolic Blood Pressure (SBP/DBP) | Weeks 12, 24, 36, 44, 52 | Absolute change in seated SBP and DBP from baseline. |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Baseline to 64 weeks | Includes adverse events, serious adverse events, and hypoglycemic events. |
Countries
China
Contacts
CONTACTZhu
Outcome results
None listed