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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
207
Drug: BGM0504 Administered SC
Drug: BGM0504 Administered SC
Drug: Placebo Administered SC
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGChange From Baseline in Hemoglobin A1c (HbA1c)
Change from baseline in HbA1c after 32 weeks of treatment.
Time frame: Week 0 to Week 32
Change From Baseline in Body Weight
Change from baseline in body weight after 52 weeks of treatment.
Time frame: Week 0 to Week 52
Change From Baseline in Hemoglobin A1c (HbA1c)
Change from baseline in HbA1c after 52weeks of treatment.
Time frame: Week 0 to Week 52
Percentage of Participants With HbA1c Target Value of <7%
Percentage of Participants With HbA1c Target Value of \<7% after 52weeks of treatment.
Time frame: Week 0 to Week 52
Percentage of Participants With HbA1c Target Value of <5.7%
Percentage of Participants With HbA1c Target Value of \<5.7%after 52weeks of treatment.
Time frame: Week 0 to Week 52
Change From Baseline in Fasting Serum Glucose
Change from baseline in FPG after 52 weeks of treatment.
Time frame: Week 0 to Week 52
Linong Ji,MD, chief physician, Peking University People's Hospital
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.