China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
NCT Number: NCT06263348
The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100029, China
This study adopts a multicenter, prospective, and observational cohort study design and does not involve randomization, control, and blinding. Patients with type 2 diabetes mellitus who were prescribed Dorzagliatin according to the package insert and physician's judgment in routine medical practice setting will be included, and the data of these patients during 52-week Dorzagliatin treatment will be collected to evaluate the safety of long-term medication.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-
Patients must meet all of the following inclusion criteria to be eligible for this study:
Exclusion criteria
-
Patients will not be eligible if they meet any of the following criteria:
During the study, patients should follow the dosing instructions from the investigator, which are made according to the package insert and the patients' conditions.
Time frame: 52 weeks
The incidences of adverse drug reactions (ADRs) and serious adverse events (SAEs) as well as ADRs of special interest during the 52-week observation period of Dorzagliatin treatment.
Time frame: 52 weeks
Changes from baseline in glycated hemoglobin (HbA1c) after 52 weeks of treatment with Dorzagliatin
Time frame: 52 weeks
The proportion of patients with HbA1c < 7% after 52 weeks of treatment
Hua Medicine Limited
Industry
A Multicenter Post-Marketing Observational Study to Evaluate the Long-Term Safety of Dorzagliatin in Patients With Type 2 Diabetes Mellitus
Acronym: BLOOM
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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