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

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

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: HR17031 injection
* Drug: INS068 injection
* Drug: SHR20004 injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18-70 age years, both inclusive; BMI is 20.0 to 40.0 kg/m2, both inclusive; Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit; HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis; 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: Use of systemic glucocorticoids within 3 months prior to the screening; Use of weight loss drugs within 3 months prior to the screening. Treatment with insulin within 1 year prior to screening (except for short-term or treatment for gestational diabetes); 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; Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)； 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; Severe uncontrolled treated or untreated hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg); Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment; History of pancreatitis (acute or chronic); Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures；

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: HR17031 injection compared with Ins068 injection and SHR20004 injection
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HR17031 injection<br> | Drug: HR17031 injection<br>* HR17031 injection<br>|
| Active Comparator: INS068 injection<br> | Drug: INS068 injection<br>* INS068 injection<br>|
| Active Comparator: SHR20004 injection<br> | Drug: SHR20004 injection<br>* SHR20004 injection<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |