Clinical trial NCT06881264: A Study Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes
Official title: A Randomized, Open-label, Parallel, Treat to Target Study Comparing the Efficacy and Safety of HR17031 With Insulin Glargine in Chines Subjects With Type 2 Diabetes Inadequately Controlled With Metformin in Combination With or Without Another Oral Antidiabetic Drug (OAD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic Drugs
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-18
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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%-11% (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. 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.
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. Received insulin therapy within 1 year prior to screening (excluding short-term therapy \[continuous treatment ≤14 days\] or insulin therapy for gestational diabetes);
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.

Primary outcomes:
measure: Change in HbA1c: Changes in HbA1c from baseline to week 26
timeFrame: week 26
Secondary outcomes:
measure: Proportion of subjects achieved HbA1c<7.0% at week 26
timeFrame: at week 26
measure: Change in body weight from baseline after 26 weeks of treatment
timeFrame: 26 weeks
measure: Proportion of subjects achieved HbA1c<7.0% without body weight gain at week 26
timeFrame: week 26
measure: Actual Daily Insulin dose at week 26
timeFrame: week 26
measure: Proportion of subjects achieved HbA1c≤6.5% at week 26
timeFrame: week 26
measure: Changes in Fasting Plasma Glucose (FPG) after 26 weeks of treatment
timeFrame: 26 weeks
measure: Proportion of subjects achieved HbA1c≤6.5%without body weight gain at week 26
timeFrame: week 26
measure: Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment
timeFrame: 12weeks
measure: Proportion of subjects achieved HbA1c≤6.5% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment
timeFrame: 12weeks
measure: Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26
timeFrame: at week 26
measure: Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 26
timeFrame: at week 26
measure: Proportion of subjects achieved HbA1c<5.7% at week 26
timeFrame: at week 26
measure: Change in mean of the 7-point SMPG profile from baseline (week 0) to week 26;
timeFrame: week 26;
measure: Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment
timeFrame: 26 weeks
measure: Changes in HbA1c from baseline after 52 weeks of treatment
timeFrame: 52 weeks
measure: Changes in FBG from baseline after 52 weeks of treatment
timeFrame: 52 weeks
measure: Changes in body weight from baseline after 52 weeks of treatment
timeFrame: 52 weeks
measure: Proportion of subjects achieved HbA1c<7% at week 52
timeFrame: at week 52
measure: Proportion of subjects achieved HbA1c≤6.5% at week 52
timeFrame: at week 52
measure: Proportion of subjects achieved HbA1c<7% without body weight gain at week 52
timeFrame: at week 52
measure: Proportion of subjects achieved HbA1c≤6.5% without body weight gain at week 52
timeFrame: at week 52
measure: Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52
timeFrame: at week 52
measure: Proportion of subjects achieved HbA1c<7.0% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52
timeFrame: at week 52
measure: Proportion of subjects achieved HbA1c≤6.5% without body weight gain and without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52
timeFrame: at week 52
measure: Proportion of subjects achieved HbA1c<5.7% at week 52
timeFrame: at week 52
measure: Change in mean of the 7-point SMPG profile from baseline (week 0) to week 52
timeFrame: week 52
measure: Change from baseline (week 0) in post-prandial SMPG increments for all meals after 52 weeks of treatment
timeFrame: 52 weeks
measure: Actual Daily Insulin dose at week 52
timeFrame: at week 52
measure: Number of Treatment-emergent Hypoglycemic event from screening to week 53
timeFrame: from screening to week 53
measure: Number of Treatment-emergent Adverse Events from screening to week 53
timeFrame: from screening to week 53
measure: Number of participants who were assessed for anti-insulin glargine antibodies, anti-INS068 antibodies and anti-HR20004 antibodies at week 27
timeFrame: at week 27
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: