Diabetes Mellitus, Type 2Phase 3NCT07913061
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
A Phase 3 study testing SHR-3167 and insulin degludec in people with Diabetes Mellitus, Type 2, 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 once-weekly SHR-3167 and once-daily Insulin Degludec in participants with Type 2 diabetes that has been treated with basal insulin. The study consists of a screening period, a treatment period and a safety follow-up period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- SHR-3167 and insulin degludec
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2026to Feb 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
- Males and females, Age≥18 years old at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 180 days prior to day of screening.
- Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to day of screening.
- 7.0% ≤ HbA1c ≤ 10.0% at screening.
Who cannot join
- Uncontrolled 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.
- Have a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
- Have acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease.
- Have hyperthyroidism (including clinical hyperthyroidism and subclinical hyperthyroidism), regardless of whether it is in the treatment stage; or hypothyroidism that requires treatment (those who have received a stable dose of thyroid hormone replacement therapy for ≥ 90 days and are willing to continue the stable treatment during the trial are excluded).
- Malignancy within 5 years prior to screening or high risk of recurrence.
- Have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
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
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Xiaoying Li
The Third Affiliated Hospital of Sun Yat-sen University
Shenzhen, Guangdong, 510000
Yanming Chen
About this study
Official title: A Multicenter, Randomized, Open-Label, Parallel-Group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin, With or Without Non-Insulin Antidiabetic Drugs
The purpose of this study is to evaluate efficacy and safety of once-weekly SHR-3167 and once-daily Insulin Degludec in participants with Type 2 diabetes that has been treated with basal insulin. The study consists of a screening period, a treatment period and a safety follow-up period. The study will last up to 33 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- 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.
insulin degludecDrug
Insulin degludec.
| Study group | Role | What they receive |
|---|---|---|
| SHR-3167 Group | Experimental | SHR-3167. Receives: Drug: SHR-3167 |
| Insulin Degludec Group | Active comparator | Insulin degludec. Receives: Drug: insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin A1c (HbA1c) (Non-inferiority)
Change from baseline in HbA1c after 26 weeks of treatment.
Measured: From baseline to Week 26.
Secondary outcomes (2)
Hypoglycemia Event Rate during the treatment period
Both during the day and at night.
Measured: From baseline to Week 26.
Adverse events (AEs)
Evaluated by laboratory tests, electrocardiogram and vital signs, etc.
Measured: From baseline to Week 26.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- A Multicenter, Randomized, Open-Label, Parallel-Group, Phase III Clinical Trial.
- Masking
- None (open label)
- Enrolment
- 680 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
- NCT07913061
- Sponsor's protocol ID
- SHR-3167-302
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Parallel-Group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin, With or Without Non-Insulin Antidiabetic Drugs
- ClinicalTrials.gov ID
- NCT07913061
- Acronym / sponsor ID
- SHR-3167-302
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 3 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 once-weekly SHR-3167 and once-daily Insulin Degludec in participants with Type 2 diabetes that has been treated with basal insulin. The study consists of a screening period, a treatment period and a safety follow-up period. The study will last up to 33 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Multicenter, Randomized, Open-Label, Parallel-Group, Phase III Clinical Trial.
| Arm | Type | Receives |
|---|---|---|
| SHR-3167 Group | Experimental | Drug: SHR-3167SHR-3167. |
| Insulin Degludec Group | Active comparator | Drug: insulin degludecInsulin degludec. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, Age≥18 years old at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus (T2DM) for at least 180 days prior to day of screening.
- Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to day of screening.
- 7.0% ≤ HbA1c ≤ 10.0% at screening.
Key exclusion criteria (8 listed)
- Uncontrolled 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.
- Have a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
- Have 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. | Drug | SHR-3167 Group |
| insulin degludecInsulin degludec. | Drug | Insulin Degludec Group |
Primary outcome
Change in Glycated Hemoglobin A1c (HbA1c) (Non-inferiority)
Time frame: From baseline to Week 26.
Change from baseline in HbA1c after 26 weeks of treatment.
2 secondary outcomes
Hypoglycemia Event Rate during the treatment period
Time frame: From baseline to Week 26.
Adverse events (AEs)
Time frame: From baseline to Week 26.
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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus, Type 2
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Active, not recruiting
Chrono Nutrition and Insulin Resistance in Diabetes
Diabetes Mellitus, Type 2
Not yet recruitingObservational study
Clinical Research Trial to Study Insulin Sensitivity Using Automated Glucose Clamp Technology
Obesity Type 2 Diabetes Mellitus, Obese Adults
Not yet recruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, Type 2 Diabetes, and Increased Cardiovascular Risk
Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
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 and insulin degludec in people with Diabetes Mellitus, Type 2, 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 8 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 3 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 Nan Xia (+86-0518-82342973, nan.xia.nx1@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin A1c (HbA1c) (Non-inferiority) (time frame: From 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 3 Nov 2026.