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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05333835
• Other study ID #: HR17031-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 8, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: April 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 455
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• HR17031 injection
HR17031 injection
• INS068 injection
INS068 injection
• SHR20004 injection
SHR20004 injection

Locations

Country	Name	City	State
China	Peking university People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in HbA1c at Week 26		at Week 26
Secondary	Mean Change From Baseline in fasting plasma glucose (FPG) at Week 26		at Week 26
Secondary	Mean Change From Baseline in Body Weight at Week 26		at Week 26
Secondary	Proportion of subjects reaching HbA1c targets (<7.0%; =6.5%) at Week 26		at Week 26
Secondary	Mean Actual Daily Insulin Dose at Week 26		at Week 26
Secondary	Number of Hypoglycaemic Episodes at Week 26		at Week 26