Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects

NCT06688123
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Phase
Phase 2
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Recruitment status
Completed
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Participants
275
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Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
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Start date
2025-01-08
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Number of sites
2
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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.
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Short title
Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-04-22
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First posted
2024-11-14
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Registry last updated
2026-06-04
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Primary completion date
2026-04-22
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Start date
2025-01-08
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Actual participants
275
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Participants
275
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
2
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Registry sponsor category
Industry
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Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06688123
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ClinicalTrials.gov ID
NCT06688123
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Change from baseline to week 20 in HbA1c (HemoglobinA1c)

    Timeframe: Week 0 to week 20.

    Change from baseline in HbA1c after 20 weeks of treatment.

  1. Percentage of participants achieving HbA1c<7.0%

    Timeframe: Week 0 to week 20.

  2. Change from baseline to week 20 in fasting plasma glucose (FPG)

    Timeframe: Week 0 to week 20.

  3. Change from baseline to week 20 in self-measured blood glucose (SMBG) before breakfast

    Timeframe: Week 0 to week 20.

  4. Number of adverse events (AEs) during the trial

    Timeframe: Week 0 to week 24.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  1. Able and willing to provide a written informed consent.
  2. Diagnosed with type 2 diabetes mellitus ≥ 6 months prior to the day of screening.
  3. A stable dose of metformin alone or in combination with a stable dose of a SGLT2 inhibitor for 3 months prior to screening.
  4. Body mass index (BMI): 18.5~35.0 kg/m2.
  5. HbA1c of 7.5%~10.0% as assessed by the local laboratory.
  6. Insulin naïve.
  7. 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.

  1. Electrocardiogram (ECG) results show clinically significant abnormalities that may affect the safety of the subject.
  2. Poor blood pressure control at screening.
  3. Diagnosis or suspicion of type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA)，other special types of diabetes or secondary diabetes mellitus.
  4. ≥1 episode of severe hypoglycemia or asymptomatic hypoglycemia within 6 months prior to screening, or recurrent hypoglycemic events within 1 month prior to screening.
  5. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state due to hyperglycemia within 6 months prior to screening.
  6. Presence of acute or chronic hepatitis, cirrhosis, or other serious liver disease other than non-alcoholic fatty liver disease.
  7. Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
  8. Malignancy or history of malignancy within 5 years prior to screening.
  9. Received any diabetes mellitus or weight-loss medication outside the inclusion criteria within 3 months prior to screening.
  10. Participation in a clinical trial of any drug or medical device within 3 months prior to screening.
  11. Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.
Sources for eligibility
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  • Jiangsu Provincial People's HospitalNanjing, China
  • Shanghai Sixth People's HospitalShanghai, China
Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)