A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes

A 26-week, Randomized, Open-label, 3-arm Parallel, Treat-to-target Study Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin With or Without One Other Oral Anti-diabetic Drug

The aim of this trial is to compare the efficacy and safety of HR17031 versus INS068 and SHR20004 in subjects with type 2 diabetes.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: HR17031 injection; Drug: INS068 injection; Drug: SHR20004 injection

• Study Type: Interventional
• Enrollment (Actual): 455
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xue Dong, M.M; Phone Number: +0518-81220121; Email: xue.dong@hengrui.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, 18-70 age years, both inclusive;
2. BMI is 20.0 to 40.0 kg/m2, both inclusive;
3. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
4. HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;
5. At screening:

1) Treatment with metformin alone on a stable dose (≥1500 mg or at the maximum tolerated dose [MTD, ≥1000 mg]) for ≥3 months, or 2) Treatment with metformin at the above dose level combined with a second OAD (AGI, SU, TZD, glinides, DPP-4i or SGLT2i) on a stable dose (≥half of the max approved dose according to local label, or at the MTD) for ≥3 months.

Exclusion Criteria:

1. Use of systemic glucocorticoids within 3 months prior to the screening;
2. Use of weight loss drugs within 3 months prior to the screening.
3. Treatment with insulin within 1 year prior to screening (except for short-term or treatment for gestational diabetes);

4. Laboratory findings at the screening visit:

   • Amylase and/or lipase >3 x upper limit of normal (ULN);
   • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN;
   • Moderate (3b) or severe renal failure or renal insufficiency or according to local contraindications for metformin;
   • Urinary albumin creatinine ratio (UACR) ≥300 mg/g;
   • Total bilirubin >2.0 x ULN;
   • Calcitonin ≥50 ng/L;
5. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)；
6. Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 6 months prior to screening and/or planned coronary, carotid or peripheral artery revascularization procedures;
7. Severe uncontrolled treated or untreated hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
8. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
9. History of pancreatitis (acute or chronic);
10. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures；

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HR17031 injection	Drug: HR17031 injection; HR17031 injection
Active Comparator: INS068 injection	Drug: INS068 injection; INS068 injection
Active Comparator: SHR20004 injection	Drug: SHR20004 injection; SHR20004 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Change From Baseline in HbA1c at Week 26	at Week 26

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean Change From Baseline in fasting plasma glucose (FPG) at Week 26	at Week 26
Mean Change From Baseline in Body Weight at Week 26	at Week 26
Proportion of subjects reaching HbA1c targets (<7.0%; ≤6.5%) at Week 26	at Week 26
Mean Actual Daily Insulin Dose at Week 26	at Week 26
Number of Hypoglycaemic Episodes at Week 26	at Week 26

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Anticipated): March 30, 2024
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HR17031-201

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