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Completed

NCT Number: NCT06881264

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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: 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.
  • 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);
  • 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.

Treatment and study plan

HR17031 injection

Drug

HR17031 injection

insulin glargine

Drug

insulin glargine

Primary outcomes

  1. Change in HbA1c: Changes in HbA1c from baseline to week 26

    Time frame: week 26

Secondary outcomes

  1. Proportion of subjects achieved HbA1c<7.0% at week 26

    Time frame: at week 26

  2. Change in body weight from baseline after 26 weeks of treatment

    Time frame: 26 weeks

  3. Proportion of subjects achieved HbA1c<7.0% without body weight gain at week 26

    Time frame: week 26

  4. Actual Daily Insulin dose at week 26

    Time frame: week 26

  5. Proportion of subjects achieved HbA1c≤6.5% at week 26

    Time frame: week 26

  6. Changes in Fasting Plasma Glucose (FPG) after 26 weeks of treatment

    Time frame: 26 weeks

  7. Proportion of subjects achieved HbA1c≤6.5%without body weight gain at week 26

    Time frame: week 26

  8. Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment

    Time frame: 12weeks

  9. Proportion of subjects achieved HbA1c≤6.5% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment

    Time frame: 12weeks

  10. 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

    Time frame: at week 26

  11. 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

    Time frame: at week 26

  12. Proportion of subjects achieved HbA1c<5.7% at week 26

    Time frame: at week 26

  13. Change in mean of the 7-point SMPG profile from baseline (week 0) to week 26;

    Time frame: week 26;

  14. Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment

    Time frame: 26 weeks

  15. Changes in HbA1c from baseline after 52 weeks of treatment

    Time frame: 52 weeks

  16. Changes in FBG from baseline after 52 weeks of treatment

    Time frame: 52 weeks

  17. Changes in body weight from baseline after 52 weeks of treatment

    Time frame: 52 weeks

  18. Proportion of subjects achieved HbA1c<7% at week 52

    Time frame: at week 52

  19. Proportion of subjects achieved HbA1c≤6.5% at week 52

    Time frame: at week 52

  20. Proportion of subjects achieved HbA1c<7% without body weight gain at week 52

    Time frame: at week 52

  21. Proportion of subjects achieved HbA1c≤6.5% without body weight gain at week 52

    Time frame: at week 52

  22. Proportion of subjects achieved HbA1c<7.0% without Level 2 and Level 3 hypoglycemic event after 12weeks treatment at week 52

    Time frame: at week 52

  23. 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

    Time frame: at week 52

  24. 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

    Time frame: at week 52

  25. Proportion of subjects achieved HbA1c<5.7% at week 52

    Time frame: at week 52

  26. Change in mean of the 7-point SMPG profile from baseline (week 0) to week 52

    Time frame: week 52

  27. Change from baseline (week 0) in post-prandial SMPG increments for all meals after 52 weeks of treatment

    Time frame: 52 weeks

  28. Actual Daily Insulin dose at week 52

    Time frame: at week 52

  29. Number of Treatment-emergent Hypoglycemic event from screening to week 53

    Time frame: from screening to week 53

  30. Number of Treatment-emergent Adverse Events from screening to week 53

    Time frame: from screening to week 53

  31. Number of participants who were assessed for anti-insulin glargine antibodies, anti-INS068 antibodies and anti-HR20004 antibodies at week 27

    Time frame: at week 27

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.