Type 2 Diabetes Mellitus (T2DM)
Conditions
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.
Interventions
Drug: BGM0504 Administered SC
DRUGDrug: : 10 mg BGM0504 Administered SC
Drug: BGM0504 Administered SC
DRUGDrug: Placebo Administered SC
Drug: Placebo Administered SC
Sponsors
BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
BrightGene Bio-Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | Week 0 to Week 32 | Change from baseline in HbA1c after 32 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight | Week 0 to Week 52 | Change from baseline in body weight after 52 weeks of treatment. |
| Change From Baseline in Hemoglobin A1c (HbA1c) | Week 0 to Week 52 | Change from baseline in HbA1c after 52weeks of treatment. |
| Percentage of Participants With HbA1c Target Value of <7% | Week 0 to Week 52 | Percentage of Participants With HbA1c Target Value of \<7% after 52weeks of treatment. |
| Percentage of Participants With HbA1c Target Value of <5.7% | Week 0 to Week 52 | Percentage of Participants With HbA1c Target Value of \<5.7%after 52weeks of treatment. |
| Change From Baseline in Fasting Serum Glucose | Week 0 to Week 52 | Change from baseline in FPG after 52 weeks of treatment. |
Countries
China
Contacts
Primary ContactLinong Ji,MD, chief physician, Peking University People's Hospital
Outcome results
None listed