A Study Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes (NCT06881264) | Clinical Trial Compass
CompletedPhase 3
A Study Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes
China401 participantsStarted 2024-04-30
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 20-40 U/day (including both ends) for at least 60 days;
✓. When screening: ①metformin monotherapy stable treatment ≥ 3 months; or ② metformin 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 criteria
✕. 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);
What they're measuring
1
Change in HbA1c: Changes in HbA1c from baseline to week 26
. 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;