A Study Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes

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)

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

Study Overview

• Status: Completed
• Conditions: Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic Drugs
• Intervention / Treatment: Drug: HR17031 injection; Drug: insulin glargine

• Study Type: Interventional
• Enrollment (Actual): 401
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 20-40 U/day (including both ends) for at least 60 days;
6. When screening: ① metformin 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.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HR17031 injection	Drug: HR17031 injection; HR17031 injection
Experimental: Treatment group B: insulin glargine	Drug: insulin glargine; insulin glargine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c: Changes in HbA1c from baseline to week 26	week 26

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects achieved HbA1c<7.0% at week 26	at week 26
Change in body weight from baseline after 26 weeks of treatment	26 weeks
Proportion of subjects achieved HbA1c<7.0% without body weight gain at week 26	week 26
Actual Daily Insulin dose at week 26	week 26
Proportion of subjects achieved HbA1c≤6.5% at week 26	week 26
Changes in Fasting Plasma Glucose (FPG) after 26 weeks of treatment	26 weeks
Proportion of subjects achieved HbA1c≤6.5%without body weight gain at week 26	week 26
Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment	12weeks
Proportion of subjects achieved HbA1c≤6.5% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment	12weeks
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	at week 26
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	at week 26
Proportion of subjects achieved HbA1c<5.7% at week 26	at week 26
Change in mean of the 7-point SMPG profile from baseline (week 0) to week 26;	week 26;
Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment	26 weeks
Changes in HbA1c from baseline after 52 weeks of treatment	52 weeks
Changes in FBG from baseline after 52 weeks of treatment	52 weeks
Changes in body weight from baseline after 52 weeks of treatment	52 weeks
Proportion of subjects achieved HbA1c<7% at week 52	at week 52
Proportion of subjects achieved HbA1c≤6.5% at week 52	at week 52
Proportion of subjects achieved HbA1c<7% without body weight gain at week 52	at week 52
Proportion of subjects achieved HbA1c≤6.5% without body weight gain at week 52	at week 52
Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52	at week 52
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	at week 52
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	at week 52
Proportion of subjects achieved HbA1c<5.7% at week 52	at week 52
Change in mean of the 7-point SMPG profile from baseline (week 0) to week 52	week 52
Change from baseline (week 0) in post-prandial SMPG increments for all meals after 52 weeks of treatment	52 weeks
Actual Daily Insulin dose at week 52	at week 52
Number of Treatment-emergent Hypoglycemic event from screening to week 53	from screening to week 53
Number of Treatment-emergent Adverse Events from screening to week 53	from screening to week 53
Number of participants who were assessed for anti-insulin glargine antibodies, anti-INS068 antibodies and anti-HR20004 antibodies at week 27	at week 27

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2024
• Primary Completion (Actual): September 19, 2025
• Study Completion (Actual): September 19, 2025

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 18, 2025

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Insulin Glargine
• Other Study ID Numbers: HR17031-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No