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Completed

NCT Number: NCT06871761

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

To compare the efficacy and safety of HR17031 injection and insulin glargine, including the changes of efficacy indicators such as HbA1c, fasting blood glucose, body weight and safety indicators such as adverse events and hypoglycemic events.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Zhu Xianyi Memorial Hospital, Tianjin Medical University

Tianjin, Tianjin Municipality, 300400, 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%-10.5% (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
  • Stable treatment with metformin alone or in combination with another OAD for ≥60 days prior to screening. 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
  • Insulin therapy other than basal insulin was used within 3 months prior to screening
  • 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. Changes in HbA1c from baseline to week 26

    Time frame: from baseline to 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 to week 26

    Time frame: from baseline to week 26

  3. Proportion of subjects achieved HbA1c<7.0% and no weight gain at week 26

    Time frame: at week 26

  4. Daily Insulin dose at week 26

    Time frame: at week 26

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

    Time frame: at week 26

  6. Changes in FPG from baseline to week 26

    Time frame: from baseline to week 26

  7. Hypoglycemic event from screening to week 27

    Time frame: from screening to week 27

  8. Adverse events from screening to week 27

    Time frame: from screening to 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 Injection With Insulin Glargine in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin, Metformin in Combination With or Without One Other Oral Antidiabetic Drug (OAD)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
Jan 13, 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.