Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
NCT Number: NCT06716203
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug: BGM0504 Administered SC
Drug: BGM0504 Administered SC
Drug: Placebo Administered SC
Time frame: Week 0 to Week 32
Change from baseline in HbA1c after 32 weeks of treatment.
Time frame: Week 0 to Week 52
Change from baseline in body weight after 52 weeks of treatment.
Time frame: Week 0 to Week 52
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% after 52weeks of treatment.
Time frame: Week 0 to Week 52
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 FPG after 52 weeks of treatment.
Contact information is provided by the study sponsor or research team.
Linong Ji,MD, chief physician, Peking University People's Hospital
CONTACT
BrightGene Bio-Medical Technology Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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