Perking University Peoples' Hospital
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
Location contact
Linong JI
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07060456
The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
Linong JI
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HRS9531-low dose
Placebo
Time frame: from baseline to Week 40
Change in HbA1c after 40 weeks of treatment.
Time frame: from baseline to Week 40
Proportion of subjects reaching HbA1<7.0% after 40 weeks of treatment.
Time frame: from baseline to Week 40
Proportion of subjects reaching HbA1≤6.5% after 40 weeks of treatment.
Time frame: from baseline to Week 40
Change in FPG after 40 weeks of treatment.
Time frame: From baseline to Week 40
Change from baseline in DTSQs after 40 weeks of treatment.
Contact information is provided by the study sponsor or research team.
Fujian Shengdi Pharmaceutical Co., Ltd.
Industry
A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.
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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