Type 2 DiabetesPhase 2NCT06688123
Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects
A Phase 2 study testing SHR-3167 and Insulin glargine 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 the efficacy and safety of SHR-3167 compared with insulin glargine after treatment in insulin naïve subjects with type 2 diabetes treated with metformin alone or in combination with SGLT2 subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SHR-3167 and Insulin glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 2 sitesChina
- Study dates
- 8 Jan 2025to 22 Apr 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent.
- Diagnosed with type 2 diabetes mellitus ≥ 6 months prior to the day of screening.
- A stable dose of metformin alone or in combination with a stable dose of a SGLT2 inhibitor for 3 months prior to screening.
- Body mass index (BMI): 18.5~35.0 kg/m2.
- HbA1c of 7.5%~10.0% as assessed by the local laboratory.
- Insulin naïve.
- Female subjects and partners of male subjects who are of childbearing potential, have no fertility plan and agree to take highly effective contraceptive measures within 6 months after signing the informed consent form to the last dose, and have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test during the screening period and are not lactating.
Who cannot join
- Electrocardiogram (ECG) results show clinically significant abnormalities that may affect the safety of the subject.
- Poor blood pressure control at screening.
- Diagnosis or suspicion of type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA)，other special types of diabetes or secondary diabetes mellitus.
- ≥1 episode of severe hypoglycemia or asymptomatic hypoglycemia within 6 months prior to screening, or recurrent hypoglycemic events within 1 month prior to screening.
- History of diabetic ketoacidosis or hyperosmolar hyperglycemic state due to hyperglycemia within 6 months prior to screening.
- Presence of acute or chronic hepatitis, cirrhosis, or other serious liver disease other than non-alcoholic fatty liver disease.
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- Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
- Malignancy or history of malignancy within 5 years prior to screening.
- Received any diabetes mellitus or weight-loss medication outside the inclusion criteria within 3 months prior to screening.
- Participation in a clinical trial of any drug or medical device within 3 months prior to screening.
- Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
About this study
Official title: A Randomized, Open-label, Treat-to-target, Parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-3167 and Insulin Glargine in Patients With Type 2 Diabetes Mellitus With Metformin Alone or in Combination With SGLT2 Inhibitors
The purpose of this study is to evaluate the efficacy and safety of SHR-3167 compared with insulin glargine after treatment in insulin naïve subjects with type 2 diabetes treated with metformin alone or in combination with SGLT2 subjects.
- Conditions
- Type 2 Diabetes
- Being tested
- SHR-3167, Insulin glargine
- 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-3167Drug
Dose level 1.
SHR-3167Drug
Dose level 2.
Insulin glargineDrug
Dose level 3.
| Study group | Role | What they receive |
|---|---|---|
| SHR-3167 group A | Experimental | Not described Receives: Drug: SHR-3167 |
| SHR-3167 group B | Experimental | Not described Receives: Drug: SHR-3167 |
| Insulin glargine group | Active comparator | Not described Receives: Drug: Insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 20 in HbA1c (HemoglobinA1c)
Change from baseline in HbA1c after 20 weeks of treatment.
Measured: Week 0 to week 20.
Secondary outcomes (4)
Percentage of participants achieving HbA1c<7.0%
Measured: Week 0 to week 20.
Change from baseline to week 20 in fasting plasma glucose (FPG)
Measured: Week 0 to week 20.
Change from baseline to week 20 in self-measured blood glucose (SMBG) before breakfast
Measured: Week 0 to week 20.
Number of adverse events (AEs) during the trial
Measured: Week 0 to week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start8 Jan 2025
- Primary completion22 Apr 2026
- Study completion22 Apr 2026
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
- Masking
- None (open label)
- Enrolment
- 275 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
- NCT06688123
- Sponsor's protocol ID
- SHR-3167-201
- Status last verified
- Jun 2026
- First submitted
- 12 Nov 2024
- Last updated
- 4 Jun 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Treat-to-target, Parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-3167 and Insulin Glargine in Patients With Type 2 Diabetes Mellitus With Metformin Alone or in Combination With SGLT2 Inhibitors
- ClinicalTrials.gov ID
- NCT06688123
- Acronym / sponsor ID
- SHR-3167-201
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 14 Nov 2024 (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 the efficacy and safety of SHR-3167 compared with insulin glargine after treatment in insulin naïve subjects with type 2 diabetes treated with metformin alone or in combination with SGLT2 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR-3167 group A | Experimental | Drug: SHR-3167 |
| SHR-3167 group B | Experimental | Drug: SHR-3167 |
| Insulin glargine group | Active comparator | Drug: Insulin glargine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to provide a written informed consent.
- Diagnosed with type 2 diabetes mellitus ≥ 6 months prior to the day of screening.
- A stable dose of metformin alone or in combination with a stable dose of a SGLT2 inhibitor for 3 months prior to screening.
- Body mass index (BMI): 18.5~35.0 kg/m2.
- HbA1c of 7.5%~10.0% as assessed by the local laboratory.
Key exclusion criteria (11 listed)
- Electrocardiogram (ECG) results show clinically significant abnormalities that may affect the safety of the subject.
- Poor blood pressure control at screening.
- Diagnosis or suspicion of type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA)，other special types of diabetes or secondary diabetes mellitus.
- ≥1 episode of severe hypoglycemia or asymptomatic hypoglycemia within 6 months prior to screening, or recurrent hypoglycemic events within 1 month prior to screening.
- History of diabetic ketoacidosis or hyperosmolar hyperglycemic state due to hyperglycemia within 6 months prior to screening.
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-3167Dose level 1. | Drug | SHR-3167 group A |
| SHR-3167Dose level 2. | Drug | SHR-3167 group B |
| Insulin glargineDose level 3. | Drug | Insulin glargine group |
Primary outcome
Change from baseline to week 20 in HbA1c (HemoglobinA1c)
Time frame: Week 0 to week 20.
Change from baseline in HbA1c after 20 weeks of treatment.
4 secondary outcomes
Percentage of participants achieving HbA1c<7.0%
Time frame: Week 0 to week 20.
Change from baseline to week 20 in fasting plasma glucose (FPG)
Time frame: Week 0 to week 20.
Change from baseline to week 20 in self-measured blood glucose (SMBG) before breakfast
Time frame: Week 0 to week 20.
Number of adverse events (AEs) during the trial
Time frame: Week 0 to week 24.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-3167 and Insulin glargine 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 11 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: finished, as of the sponsor's last update on 4 Jun 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline to week 20 in HbA1c (HemoglobinA1c) (time frame: Week 0 to week 20.). 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 4 Jun 2026.