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

Phase 2

• Conditions: Type 2 Diabetes
• Interventions: Drug: HR17031 injection; Drug: INS068 injection; Drug: SHR20004 injection

• Registration Number: NCT05333835
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-19
• Study Start: 2022-07-08
• Last Update Submitted: 2023-04-23
• Last Update Posted: 2023-04-25
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 455

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HR17031 injection	HR17031 injection	-
INS068 injection	INS068 injection	-
SHR20004 injection	SHR20004 injection	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in HbA1c at Week 26	at Week 26

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking university People's Hospital; 🇨🇳 Beijing, Beijing, China