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

NCT06881264 | Completed Phase 3

• 1 other identifier: HR17031-301
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

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

Conditions

Adult Patients With Type 2 Diabetes Uncontrolled on Oral Antidiabetic Drugs

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c: Changes in HbA1c from baseline to week 26

  week 26

Secondary Outcomes (31)

• 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

Study Arms (2)

Treatment group A: HR17031 injection

EXPERIMENTAL

Drug: HR17031 injection

Treatment group B: insulin glargine

EXPERIMENTAL

Drug: insulin glargine

Interventions

HR17031 injection DRUG

HR17031 injection

Treatment group A: HR17031 injection

insulin glargine DRUG

insulin glargine

Treatment group B: insulin glargine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Interventions

Insulin Glargine

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: April 30, 2024
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CN (1)