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Not yet recruitingNCT07913061Updated Nov 3, 2026

A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin

A Phase 3 interventional study of SHR-3167 and insulin degludec in Diabetes Mellitus, Type 2, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
680
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. The study will last up to 33 weeks.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 680 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 573 studies on the registry; 88 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males and females, Age≥18 years old at the time of signing .
  2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 180 days prior to day of screening.
  3. Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to day of screening.
  4. 7.0% ≤ ≤ 10.0% at screening.

Exclusion criteria

Exclusion Criteria:

  1. Uncontrolled hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at screening.
  2. Diagnosed or suspected with type 1 diabetes mellitus, latent diabetes mellitus in adult (LADA), other special types of diabetes or secondary diabetes.
  3. Known or suspected allergy or intolerance to the test drug or .
  4. Have a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
  5. Have acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease.
  6. 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).
  7. within 5 years prior to screening or high risk of recurrence.
  8. Have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
680 participants (estimated)

Study arms

  • Experimental
    SHR-3167 Group

    SHR-3167.

    Drug: SHR-3167

  • Active comparator
    Insulin Degludec Group

    Insulin degludec.

    Drug: insulin degludec

Interventions

06

What researchers measure

Primary outcomes

  1. Change in Glycated Hemoglobin A1c (HbA1c) (Non-inferiority)

    Change from baseline in HbA1c after 26 weeks of treatment.

    Time frame: From baseline to Week 26.

Secondary outcomes

  1. Hypoglycemia Event Rate during the treatment period

    Both during the day and at night.

    Time frame: From baseline to Week 26.

  2. Adverse events (AEs)

    Evaluated by laboratory tests, electrocardiogram and vital signs, etc.

    Time frame: From baseline to Week 26.

07

Study locations

2 sites
  • The Third Affiliated Hospital of Sun Yat-sen University
    Shenzhen, Guangdong 510000, China
    • Yanming Chen · Principal investigator
  • Zhongshan Hospital Affiliated to Fudan University
    Shanghai, Shanghai Municipality 200032, China
    • Xiaoying Li · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07913061
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Nan Xia
Contact
nan.xia.nx1@hengrui.com
+86-0518-82342973
Guangming Feng
Contact
guangming.feng@hengrui.com
+86-0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: SHR-3167

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