Type 2 Diabetes MellitusPhase 2NCT07018453
A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
A Phase 2 study testing SHR-3167 and Insulin Degludec in people with Type 2 Diabetes Mellitus, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the glycemic control and safety of SHR-3167 and Insulin Degludec in type 2 diabetic participants treated with basal insulin with or without oral antidiabetic drugs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- SHR-3167 and Insulin Degludec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 2 sitesChina
- Study dates
- 16 Jul 2025to May 2026
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, 18 - 65 years old at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to the day of screening.
- Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to the day of screening.
- 6.5% ≤ HbA1c ≤ 10.0% at screening.
Who cannot join
- Uncontrollable hypertension (with or without antihypertensive treatment) : systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at screening.
- Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes.
- Known or suspected allergy or intolerance to the test drug or excipient.
- There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
- There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease.
- There is hyperthyroidism or hypothyroidism requiring treatment.
Show all 9Show fewer
- Malignancy within 5 years prior to screening or high risk of recurrence.
- Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
- Participated in clinical trials of any drug or medical device within 3 months prior to screening.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Randomized, Open-label, Treat-to-target, Parallel-Controlled Phase II Clinical Study Investigating the Efficacy and Safety of SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
The purpose of this study is to evaluate the glycemic control and safety of SHR-3167 and Insulin Degludec in type 2 diabetic participants treated with basal insulin with or without oral antidiabetic drugs.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- SHR-3167, Insulin Degludec
- 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
SHR-3167 Injection.
Insulin DegludecDrug
Insulin Degludec Injection.
| 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 Degludec Group | Active comparator | Not described Receives: Drug: Insulin Degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycosylated hemoglobin (HbA1c) from baseline.
Measured: 16 weeks.
Secondary outcomes (3)
Proportion of subjects with glycosylated hemoglobin (HbA1c) < 7.0% from baseline.
Measured: 16 weeks.
Change in fasting plasma glucose (FPG) from baseline.
Measured: 16 weeks.
Change in self-measured (capillary) blood glucose (SMBG) from baseline.
Measured: 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start16 Jul 2025
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 173 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
- NCT07018453
- Sponsor's protocol ID
- SHR-3167-202
- Status last verified
- Nov 2025
- First submitted
- 5 Jun 2025
- Last updated
- 18 Nov 2025
- 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 18 Nov 2025. 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 Investigating the Efficacy and Safety of SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
- ClinicalTrials.gov ID
- NCT07018453
- Acronym / sponsor ID
- SHR-3167-202
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 12 Jun 2025 (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 glycemic control and safety of SHR-3167 and Insulin Degludec in type 2 diabetic participants treated with basal insulin with or without oral antidiabetic drugs.
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 Degludec Group | Active comparator | Drug: Insulin Degludec |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, 18 - 65 years old at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to the day of screening.
- Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to the day of screening.
- 6.5% ≤ HbA1c ≤ 10.0% at screening.
Key exclusion criteria (9 listed)
- Uncontrollable hypertension (with or without antihypertensive treatment) : systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at screening.
- Diagnosed or suspected with type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes.
- Known or suspected allergy or intolerance to the test drug or excipient.
- There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
- There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease.
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-3167SHR-3167 Injection. | Drug | SHR-3167 Group A, SHR-3167 Group B |
| Insulin DegludecInsulin Degludec Injection. | Drug | Insulin Degludec Group |
Primary outcome
Change in glycosylated hemoglobin (HbA1c) from baseline.
Time frame: 16 weeks.
3 secondary outcomes
Proportion of subjects with glycosylated hemoglobin (HbA1c) < 7.0% from baseline.
Time frame: 16 weeks.
Change in fasting plasma glucose (FPG) from baseline.
Time frame: 16 weeks.
Change in self-measured (capillary) blood glucose (SMBG) from baseline.
Time frame: 16 weeks.
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 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Type 2 Diabetes Mellitus
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
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 Degludec in people with Type 2 Diabetes Mellitus, 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. 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?
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?
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 in glycosylated hemoglobin (HbA1c) from baseline. (time frame: 16 weeks.). 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 18 Nov 2025.