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

Phase
Recruitment status
Participants
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Start date
Number of sites

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
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Registry sponsor category
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design

  1. Mean Change From Baseline in HbA1c at Week 26

    Timeframe: at Week 26

  1. Mean Change From Baseline in fasting plasma glucose (FPG) at Week 26

    Timeframe: at Week 26

  2. Mean Change From Baseline in Body Weight at Week 26

    Timeframe: at Week 26

  3. Proportion of subjects reaching HbA1c targets (<7.0%; ≤6.5%) at Week 26

    Timeframe: at Week 26

  4. Mean Actual Daily Insulin Dose at Week 26

    Timeframe: at Week 26

  5. Number of Hypoglycaemic Episodes at Week 26

    Timeframe: at Week 26

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No

  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.

  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;

Sources for eligibility

  • Peking university People's HospitalBeijing, China
Sources for sites

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)