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Completed

NCT Number: NCT06263348

A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

About this study

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.

Who can participate

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:

  • Male or female ≥ 18 years of age at the time of signing the informed consent form;
  • Patients with type 2 diabetes mellitus diagnosed at screening;
  • Patients who have been prescribed Dorzagliatin according to the package insert and physician's judgment (the prescription should be made before enrolling the patient in this study and is independent of the enrollment decision);
  • Willingness to participate in the study and sign written informed consent.

Exclusion criteria

-

Patients will not be eligible if they meet any of the following criteria:

  • Other types of clinically diagnosed diabetes, such as type 1 diabetes or other special types of diabetes;
  • Patients who, in the opinion of the investigator, are at risk of allergy or intolerance to any component of Dorzagliatin;
  • Patients who, in the judgment of the investigator, cannot complete or are not suitable for this study.

Treatment and study plan

Dorzagliatin tablets

Drug

During the study, patients should follow the dosing instructions from the investigator, which are made according to the package insert and the patients' conditions.

Primary outcomes

  1. Incidences of ADRs and SAEs

    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.

Secondary outcomes

  1. Blood glucose indicators

    Time frame: 52 weeks

    Changes from baseline in glycated hemoglobin (HbA1c) after 52 weeks of treatment with Dorzagliatin

  2. Response rate

    Time frame: 52 weeks

    The proportion of patients with HbA1c < 7% after 52 weeks of treatment

Sponsors and collaborators

Lead sponsor

Hua Medicine Limited

Industry

Collaborators

  • Kun Tuo Xincheng Pharmaceutical Researchand Development(Beijing)Co.,Ltd.

Registry information

Official study title

A Multicenter Post-Marketing Observational Study to Evaluate the Long-Term Safety of Dorzagliatin in Patients With Type 2 Diabetes Mellitus

Acronym: BLOOM

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 16, 2024
Registry last updated
Jul 10, 2026

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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