A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes
- 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.
- Short title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2024-03-30
- First posted
- 2022-04-19
- Registry last updated
- 2023-04-25
- Primary completion date
- 2024-03-30
- Start date
- 2022-07-08
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05333835
- ClinicalTrials.gov ID
- NCT05333835
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Mean Change From Baseline in HbA1c at Week 26
Timeframe: at Week 26
Mean Change From Baseline in fasting plasma glucose (FPG) at Week 26
Timeframe: at Week 26
Mean Change From Baseline in Body Weight at Week 26
Timeframe: at Week 26
Proportion of subjects reaching HbA1c targets (<7.0%; ≤6.5%) at Week 26
Timeframe: at Week 26
Mean Actual Daily Insulin Dose at Week 26
Timeframe: at Week 26
Number of Hypoglycaemic Episodes at Week 26
Timeframe: at Week 26
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Healthy volunteers
- No
- 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.
-
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;
- Peking university People's HospitalBeijing, China
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Type 2 diabetes mellitus Primary condition