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> Record changed: 2026-10-13

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

NCT05333835

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

Phase

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

Recruitment status

Unknown

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

Participants

455

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

Start date

2022-07-08

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

## Title and summary

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Recruitment status**

Unknown

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Phase**

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

## Dates

**Completion date**

2024-03-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**First posted**

2022-04-19

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Registry last updated**

2023-04-25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Primary completion date**

2024-03-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Start date**

2022-07-08

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

## Size and sites

**Actual participants**

455

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Participants**

455

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Protocol amendments**

2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

## Sponsor and oversight

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Lead sponsor**

Jiangsu HengRui Medicine Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

## Identifiers

**Registry ID**

NCT05333835

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**ClinicalTrials.gov ID**

NCT05333835

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

No masking

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

## Outcomes

### Primary outcomes

1. Mean Change From Baseline in HbA1c at Week 26  
Timeframe: at Week 26

### Secondary outcomes

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Maximum age**

70 Years

**Healthy volunteers**

No

### 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；

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

## Sites

- Peking university People's HospitalBeijing, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05333835)

## Related records

### Drugs (1)

- [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md)

### Lead sponsors (1)

- [Jiangsu HengRui Medicine Co., Ltd.](https://trialight.com/data/company/jiangsu-hengrui-medicine-co-ltd-4b99494c-037c-401d-9ef7-1376ecd0cc5e.md)

### Conditions (1)

- [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition

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