NCT06716203
Recruiting
Phase 3
A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients with Type 2 Diabetes, Inadequately Controlled with Diet and Exercise Alone
ConditionsType 2 Diabetes Mellitus (T2DM)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
- Enrollment
- 207
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Hemoglobin A1c (HbA1c)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise.
The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.
Investigators
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.
Outcomes
Primary Outcomes
Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Week 0 to Week 32
Change from baseline in HbA1c after 32 weeks of treatment.
Secondary Outcomes
- Change From Baseline in Body Weight(Week 0 to Week 52)
- Change From Baseline in Hemoglobin A1c (HbA1c)(Week 0 to Week 52)
- Percentage of Participants With HbA1c Target Value of <7%(Week 0 to Week 52)
- Percentage of Participants With HbA1c Target Value of <5.7%(Week 0 to Week 52)
- Change From Baseline in Fasting Serum Glucose(Week 0 to Week 52)
Study Sites (1)
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