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

NCT05333835 | Unknown Phase 2

• 1 other identifier: HR17031-201
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in HbA1c at Week 26

  at Week 26

Secondary Outcomes (5)

• 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

Study Arms (3)

HR17031 injection

EXPERIMENTAL

Drug: HR17031 injection

INS068 injection

ACTIVE COMPARATOR

Drug: INS068 injection

SHR20004 injection

ACTIVE COMPARATOR

Drug: SHR20004 injection

Interventions

HR17031 injection DRUG

HR17031 injection

HR17031 injection

INS068 injection DRUG

INS068 injection

INS068 injection

SHR20004 injection DRUG

SHR20004 injection

SHR20004 injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking university People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HR17031 injection compared with Ins068 injection and SHR20004 injection

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: July 8, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: April 25, 2023

Record last verified: 2022-04

Locations

CN (1)