Type 2 DiabetesPhase 2NCT05333835
A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes
A Phase 2 study testing HR17031 injection, INS068 injection and SHR20004 injection in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HR17031 injection, INS068 injection and SHR20004 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2022to 30 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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；
Trial locations and contacts
1 site in 1 country.
China1 site
Peking university People's Hospital
Beijing, Beijing Municipality, 100044
About this study
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
The aim of this trial is to compare the efficacy and safety of HR17031 versus INS068 and SHR20004 in subjects with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- HR17031 injection, INS068 injection, SHR20004 injection
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR17031 injectionDrug
HR17031 injection
INS068 injectionDrug
INS068 injection
SHR20004 injectionDrug
SHR20004 injection
| Study group | Role | What they receive |
|---|---|---|
| HR17031 injection | Experimental | Not described Receives: Drug: HR17031 injection |
| INS068 injection | Active comparator | Not described Receives: Drug: INS068 injection |
| SHR20004 injection | Active comparator | Not described Receives: Drug: SHR20004 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in HbA1c at Week 26
Measured: at Week 26
Secondary outcomes (5)
Mean Change From Baseline in fasting plasma glucose (FPG) at Week 26
Measured: at Week 26
Mean Change From Baseline in Body Weight at Week 26
Measured: at Week 26
Proportion of subjects reaching HbA1c targets (<7.0%; ≤6.5%) at Week 26
Measured: at Week 26
Mean Actual Daily Insulin Dose at Week 26
Measured: at Week 26
Number of Hypoglycaemic Episodes at Week 26
Measured: at Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start8 Jul 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HR17031 injection compared with Ins068 injection and SHR20004 injection
- Masking
- None (open label)
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333835
- Sponsor's protocol ID
- HR17031-201
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05333835
- Acronym / sponsor ID
- HR17031-201
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to compare the efficacy and safety of HR17031 versus INS068 and SHR20004 in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- HR17031 injection compared with Ins068 injection and SHR20004 injection
| Arm | Type | Receives |
|---|---|---|
| HR17031 injection | Experimental | Drug: HR17031 injection |
| INS068 injection | Active comparator | Drug: INS068 injection |
| SHR20004 injection | Active comparator | Drug: SHR20004 injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (16 listed)
- 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:
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR17031 injectionHR17031 injection | Drug | HR17031 injection |
| INS068 injectionINS068 injection | Drug | INS068 injection |
| SHR20004 injectionSHR20004 injection | Drug | SHR20004 injection |
Primary outcome
Mean Change From Baseline in HbA1c at Week 26
Time frame: at Week 26
5 secondary outcomes
Mean Change From Baseline in fasting plasma glucose (FPG) at Week 26
Time frame: at Week 26
Mean Change From Baseline in Body Weight at Week 26
Time frame: at Week 26
Proportion of subjects reaching HbA1c targets (<7.0%; ≤6.5%) at Week 26
Time frame: at Week 26
Mean Actual Daily Insulin Dose at Week 26
Time frame: at Week 26
Number of Hypoglycaemic Episodes at Week 26
Time frame: at Week 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HR17031 injection, INS068 injection and SHR20004 injection in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in HbA1c at Week 26 (time frame: at Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.