Clinical trial NCT05333835: A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-19
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HR17031 injection compared with Ins068 injection and SHR20004 injection
Primary purpose: TREATMENT

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.


Eligibility criteria: 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；

Primary outcomes:
measure: Mean Change From Baseline in HbA1c at Week 26
timeFrame: at Week 26
Secondary outcomes:
measure: Mean Change From Baseline in fasting plasma glucose (FPG) at Week 26
timeFrame: at Week 26
measure: Mean Change From Baseline in Body Weight at Week 26
timeFrame: at Week 26
measure: Proportion of subjects reaching HbA1c targets (<7.0%; ≤6.5%) at Week 26
timeFrame: at Week 26
measure: Mean Actual Daily Insulin Dose at Week 26
timeFrame: at Week 26
measure: Number of Hypoglycaemic Episodes at Week 26
timeFrame: at Week 26
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university People's Hospital
state: Beijing
Study officials:
References: