New diabetes drug shows promise in phase 2 trial
NCT ID NCT07018453
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new medication, SHR-3167, against a standard long-acting insulin (insulin degludec) in people with type 2 diabetes who already use basal insulin. The goal is to see which one controls blood sugar better and is safer. About 173 adults aged 18-65 with type 2 diabetes for at least 6 months are taking part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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173 people
The number who actually took part.
- Started
-
Jul 2025
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males and females, 18 - 65 years old at the time of signing informed consent. 2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months prior to the day of screening. 3. Treatment with basal insulin with or without oral antidiabetic drugs at least 90 days prior to the day of screening. 4. 6.5% ≤ HbA1c ≤ 10.0% at screening. Exclusion Criteria: 1. Uncontrollable 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 autoimmune 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 excipient. 4. There was a history of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months. 5. There is acute or chronic hepatitis, liver cirrhosis, or a history of other serious liver diseases other than non-alcoholic fatty liver disease. 6. There is hyperthyroidism or hypothyroidism requiring treatment. 7. Malignancy within 5 years prior to screening or high risk of recurrence. 8. Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening. 9. Participated in clinical trials of any drug or medical device within 3 months prior to screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000, China
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Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032, China
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