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UnknownPhase 2

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

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

Asset

Noiiglutide / HS-20004 / SHR20004

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

455

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 20-40HbA1c 7.5-11%

Primary endpoint

HbA1c

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05333835
Org study IDHR17031-201

Timeline

Milestones

Study first posted2022-04-19actual
Study start2022-07-08actual
Last update posted2023-04-25actual
Primary completion2024-03-30estimated
Study completion2024-03-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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;

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
4
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Mean Change From Baseline in Body Weight at Week 26

Time frame:at Week 26

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Mean Change From Baseline in HbA1c at Week 26

Time frame:at Week 26

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:at Week 26

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:at Week 26

threshold achievement, improvement

Secondary/protocol endpoint

Mean Actual Daily Insulin Dose at Week 26

Time frame:at Week 26

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of Hypoglycaemic Episodes at Week 26

Time frame:at Week 26

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.