Type 2 DiabetesPhase 3NCT07920939
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
A Phase 3 study testing SHR-3167 Injection and Insulin glargine (IGlar) in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this study is to evaluate efficacy and safety of SHR-3167 versus Insulin glargine in insulin-naive type 2 diabetes inadequately controlled on non-insulin anti-diabetic drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SHR-3167 Injection and Insulin glargine (IGlar)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2026to Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Before participating in any activities related to this trial, I have agreed and signed the informed consent form, and I am willing and able to follow the trial protocol to complete the study.
- I am 18 years or older when signing the informed consent, with no gender restriction.
- According to the 'Chinese Guidelines for Diabetes Prevention and Treatment (2024 edition)', I have been diagnosed with T2DM for at least 180 days before screening.
- Before screening, I have been on stable treatment with 1 to 3 of non-insulin antihyperglycemic drugs for at least 90 days.
- At screening, my HbA1c measured by the central lab is between 7.0% and 11.0%, inclusive.
- At screening, my body mass index (BMI) is ≤40.0 kg/m².
- Female participants of childbearing potential and male participants with partners of childbearing potential agree to use effective contraception after signing the informed consent, and have no plans to donate eggs/sperm; women of childbearing potential have a negative pregnancy test during the screening period and are not breastfeeding.
Who cannot join
- Abnormal ECG findings that are clinically significant and may affect participant safety.
- Poorly controlled blood pressure.
- Diagnosis or suspected type 1 diabetes (T1DM), latent autoimmune diabetes in adults (LADA), specific types of diabetes, or secondary diabetes.
- level 2 or 3 hypoglycemia or hypoglycemia with unconsciousness in the past 6 months; or ≥2 episodes of level 3 hypoglycemia in the past year before screening.
- Diabetic ketoacidosis, lactic acidosis, or hyperglycemic hyperosmolar state/coma within the past 6 months.
- Severe chronic diabetic complications; or non-proliferative diabetic retinopathy requiring local treatment.
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- Malignant tumors within the past 5 years, or high risk of cancer onset/recurrence, or presence of potential malignant tumors.
- Use of insulin within the 2 years
- Participation in any drug or medical device clinical trial within 90 days.
- Any condition that the investigator deems may endanger participant safety, interfere with trial outcome evaluation, affect protocol compliance, or otherwise make participation inappropriate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Yun Liu
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Weiping Jia
About this study
Official title: A Phase III, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
The purpose of this study is to evaluate efficacy and safety of SHR-3167 versus Insulin glargine in insulin-naive type 2 diabetes inadequately controlled on non-insulin anti-diabetic drugs. The hypothesis is that SHR-3167 is non-inferior to insulin glargine in the change of HbA1c from baseline after 26 weeks of treatment.
- Conditions
- Type 2 Diabetes
- Being tested
- SHR-3167 Injection, Insulin glargine (IGlar)
- 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.
SHR-3167 InjectionDrug
SHR-3167 Injection
Insulin glargine (IGlar)Drug
Insulin glargine (IGlar)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | SHR-3167 Injection Receives: Drug: SHR-3167 Injection |
| Treatment group B | Active comparator | Insulin glargine (IGlar) Receives: Drug: Insulin glargine (IGlar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline to week 26 (non-inferiority test)
Measured: baseline to week 26
Secondary outcomes (9)
Percentage of time in range (TIR) between 3.9-10.0 mmol/L (inclusive) during weeks 23 to 26, assessed by continuous glucose monitoring system (CGMS)
Measured: weeks 23 to 26
Change in HbA1c from baseline to week 26 (superiority test)
Measured: baseline to week 26
Change in HbA1c from baseline to week 52
Measured: baseline to week 52
Percentage of participants at week 26 and 52 achieving HbA1c <7%
Measured: week 26 and 52
Percentage of participants at week 26 and 52 achieving HbA1c <7% without level 2-3 hypoglycemia;
Measured: week 26 and 52
Change in fasting plasma glucose (FPG) from baseline to week 26 and 52
Measured: baseline to week 26 and 52
Change in pre-breakfast self-monitored blood glucose (SMBG) from baseline to week 26 and 52
Measured: baseline to week 26 and 52
Percentage of time in range (TIR) of 3.9-10.0 mmol/L (inclusive) measured by CGMS during weeks 49-52
Measured: weeks 49-52
Incidence and event rate of hypoglycemia from baseline to week 26 and 52
Measured: baseline to week 26 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionJul 2028 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to receive either once-weekly SHR-3167 injection or once-daily insulin glargine injection (parallel-group design).
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
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
- NCT07920939
- Sponsor's protocol ID
- SHR-3167-301
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07920939
- Acronym / sponsor ID
- SHR-3167-301
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 6 Nov 2026 (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 purpose of this study is to evaluate efficacy and safety of SHR-3167 versus Insulin glargine in insulin-naive type 2 diabetes inadequately controlled on non-insulin anti-diabetic drugs. The hypothesis is that SHR-3167 is non-inferior to insulin glargine in the change of HbA1c from baseline after 26 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to receive either once-weekly SHR-3167 injection or once-daily insulin glargine injection (parallel-group design).
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-3167 InjectionSHR-3167 Injection |
| Treatment group B | Active comparator | Drug: Insulin glargine (IGlar)Insulin glargine (IGlar) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Before participating in any activities related to this trial, I have agreed and signed the informed consent form, and I am willing and able to follow the trial protocol to complete the study.
- I am 18 years or older when signing the informed consent, with no gender restriction.
- According to the 'Chinese Guidelines for Diabetes Prevention and Treatment (2024 edition)', I have been diagnosed with T2DM for at least 180 days before screening.
- Before screening, I have been on stable treatment with 1 to 3 of non-insulin antihyperglycemic drugs for at least 90 days.
- At screening, my HbA1c measured by the central lab is between 7.0% and 11.0%, inclusive.
Key exclusion criteria (10 listed)
- Abnormal ECG findings that are clinically significant and may affect participant safety.
- Poorly controlled blood pressure.
- Diagnosis or suspected type 1 diabetes (T1DM), latent autoimmune diabetes in adults (LADA), specific types of diabetes, or secondary diabetes.
- level 2 or 3 hypoglycemia or hypoglycemia with unconsciousness in the past 6 months; or ≥2 episodes of level 3 hypoglycemia in the past year before screening.
- Diabetic ketoacidosis, lactic acidosis, or hyperglycemic hyperosmolar state/coma within the past 6 months.
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 |
|---|---|---|
| SHR-3167 InjectionSHR-3167 Injection | Drug | Treatment group A |
| Insulin glargine (IGlar)Insulin glargine (IGlar) | Drug | Treatment group B |
Primary outcome
Change in HbA1c from baseline to week 26 (non-inferiority test)
Time frame: baseline to week 26
9 secondary outcomes
Percentage of time in range (TIR) between 3.9-10.0 mmol/L (inclusive) during weeks 23 to 26, assessed by continuous glucose monitoring system (CGMS)
Time frame: weeks 23 to 26
Change in HbA1c from baseline to week 26 (superiority test)
Time frame: baseline to week 26
Change in HbA1c from baseline to week 52
Time frame: baseline to week 52
Percentage of participants at week 26 and 52 achieving HbA1c <7%
Time frame: week 26 and 52
Percentage of participants at week 26 and 52 achieving HbA1c <7% without level 2-3 hypoglycemia;
Time frame: week 26 and 52
Change in fasting plasma glucose (FPG) from baseline to week 26 and 52
Time frame: baseline to week 26 and 52
Change in pre-breakfast self-monitored blood glucose (SMBG) from baseline to week 26 and 52
Time frame: baseline to week 26 and 52
Percentage of time in range (TIR) of 3.9-10.0 mmol/L (inclusive) measured by CGMS during weeks 49-52
Time frame: weeks 49-52
Incidence and event rate of hypoglycemia from baseline to week 26 and 52
Time frame: baseline to week 26 and 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-3167 Injection and Insulin glargine (IGlar) in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites 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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liping Xiang (+0518-82342973, liping.xiang.lx7@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from baseline to week 26 (non-inferiority test) (time frame: baseline to 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 6 Nov 2026.