A Trial Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes
Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Mar 6, 2025
Trial Information
Current as of April 22, 2025
Active, not recruiting
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Male or female, aged 18-75 years at the time of signing the informed consent (both ends included)
- • 2. Body Mass index (BMI) of 20.0-40.0 kg/m2 (both ends included)
- • 3. Diagnosed with type 2 diabetes for at least 90 days prior to screening
- • 4. Tested by local laboratory, HbA1c is 7.5%-10.5% (including both ends)
- • 5. Before screening, the daily basal insulin dose had been stabilized at 20-40U/ day (including both ends) for at least 60 days
- • 6. Stable treatment with metformin alone or in combination with another OAD for ≥60 days prior to screening. Metformin dose ≥1500 mg/ day or maximum tolerated dose.
- • 7. Ability and willingness to comply with protocol requirements, including self-monitoring of blood glucose, recording subject diary, and using pre-filled injection pen.
- Exclusion Criteria:
- • 1. Known or suspected allergy to the investigational drug product or its components or excipients;
- • 2. Systemic glucocorticoid use within 3 months prior to screening
- • 3. Use of weight loss drugs within 3 months prior to screening
- • 4. Insulin therapy other than basal insulin was used within 3 months prior to screening
- • 5. Cardiovascular disease, defined as congestive heart failure (NYHA III-IV), unstable angina pectoris, stroke (except lacunar infarction without symptoms), myocardial infarction, coronary revascularization within 6 months prior to screening; And/or coronary, carotid, or peripheral arterial revascularization is planned at screening
- • 6. (with or without treatment) uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
- • 7. Proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, intermittent claudication at screening;
- • 8. Patients diagnosed with mental disorders; Mentally incapacitated or speech impediment, unable to fully understand the trial protocol or unwilling to collaborate;
- • 9. Known or suspected abuse of alcohol or narcotics;
- • 10. Previous history of pancreatitis (acute or chronic)
- • 11. During pregnancy or lactation;fertile women (WOCBP) or men who have fertility plan or unwilling to use appropriate contraceptive methods from the signing of the informed consent to 3 months after last use of the investigational drug product;
- • 12. Any condition, determined by the investigator, interfere with the efficacy or safety results of the trial.
About Jiangsu Hengrui Medicine Co., Ltd.
Jiangsu Hengrui Medicine Co., Ltd. is a leading pharmaceutical company based in China, dedicated to the research, development, manufacturing, and commercialization of innovative therapies across various medical fields, including oncology, anesthesia, and imaging. Established in 1970, Hengrui is committed to advancing healthcare through cutting-edge drug development and a robust pipeline of both novel and generic medications. The company emphasizes rigorous clinical research and adheres to international regulatory standards, positioning itself as a key player in the global pharmaceutical landscape. With a strong focus on quality and patient-centered solutions, Hengrui aims to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tianjin, Tianjin, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported