Status:
ACTIVE_NOT_RECRUITING
A Study Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic Drugs
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The aim of this trial is to confirm the efficacy of HR17031 in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents
Eligibility Criteria
Inclusion
- Male or female, aged 18-75 years at the time of signing the informed consent (both ends included)
- Body Mass index (BMI) of 20.0-40.0 kg/m2 (both ends included)
- Diagnosed with type 2 diabetes for at least 90 days prior to screening
- Tested by local laboratory, HbA1c is 7.5%-11% (including both ends)
- Before screening, the daily basal insulin dose had been stabilized at 20-40U/ day (including both ends) for at least 60 days
- When screening:
- ①metformin monotherapy stable treatment ≥3 months; or
- ②metformin combined with another OAD for stable treatment for ≥3 months; Metformin dose ≥1500 mg/ day or maximum tolerated dose.
- Ability and willingness to comply with protocol requirements, including self-monitoring of blood glucose, recording subject diary, and using pre-filled injection pen.
Exclusion
- Known or suspected allergy to the investigational drug product or its components or excipients;
- Systemic glucocorticoid use within 3 months prior to screening
- Use of weight loss drugs within 3 months prior to screening
- Received insulin therapy within 1 year prior to screening (excluding short-term therapy \[continuous treatment ≤14 days\] or insulin therapy for gestational diabetes);
- 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
- (with or without treatment) uncontrolled severe hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
- Proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, intermittent claudication at screening;
- Patients diagnosed with mental disorders; Mentally incapacitated or speech impediment, unable to fully understand the trial protocol or unwilling to collaborate;
- Known or suspected abuse of alcohol or narcotics;
- Previous history of pancreatitis (acute or chronic)
- 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;
- Any condition, determined by the investigator, interfere with the efficacy or safety results of the trial.
Key Trial Info
Start Date :
April 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2025
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT06881264
Start Date
April 30 2024
End Date
September 22 2025
Last Update
July 3 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044