NCT06688123CompletedPhase 2
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
Jiangsu HengRui Medicine Co., Ltd.2 sites in 1 country275 target enrollmentStarted: January 8, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 275
- Locations
- 2
- Primary Endpoint
- Change from baseline to week 20 in HbA1c (HemoglobinA1c)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able and willing to provide a written informed consent.
- •Diagnosed with type 2 diabetes mellitus ≥ 6 months prior to the day of screening.
- •A stable dose of metformin alone or in combination with a stable dose of a SGLT2 inhibitor for 3 months prior to screening.
- •Body mass index (BMI): 18.5~35.0 kg/m
- •HbA1c of 7.5%~10.0% as assessed by the local laboratory.
- •Insulin naïve.
- •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.
Exclusion Criteria
- •Electrocardiogram (ECG) results show clinically significant abnormalities that may affect the safety of the subject.
- •Poor blood pressure control at screening.
- •Diagnosis or suspicion of type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA)，other special types of diabetes or secondary diabetes mellitus.
- •≥1 episode of severe hypoglycemia or asymptomatic hypoglycemia within 6 months prior to screening, or recurrent hypoglycemic events within 1 month prior to screening.
- •History of diabetic ketoacidosis or hyperosmolar hyperglycemic state due to hyperglycemia within 6 months prior to screening.
- •Presence of acute or chronic hepatitis, cirrhosis, or other serious liver disease other than non-alcoholic fatty liver disease.
- •Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
- •Malignancy or history of malignancy within 5 years prior to screening.
- •Received any diabetes mellitus or weight-loss medication outside the inclusion criteria within 3 months prior to screening.
- •Participation in a clinical trial of any drug or medical device within 3 months prior to screening.
- •Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.
Arms & Interventions
SHR-3167 group B
Experimental
Intervention: SHR-3167 (Drug)
Insulin glargine group
Active Comparator
Intervention: Insulin glargine (Drug)
SHR-3167 group A
Experimental
Intervention: SHR-3167 (Drug)
Outcomes
Primary Outcomes
Change from baseline to week 20 in HbA1c (HemoglobinA1c)
Time Frame: Week 0 to week 20.
Change from baseline in HbA1c after 20 weeks of treatment.
Secondary Outcomes
- Change from baseline to week 20 in self-measured blood glucose (SMBG) before breakfast(Week 0 to week 20.)
- Number of adverse events (AEs) during the trial(Week 0 to week 24.)
- Percentage of participants achieving HbA1c<7.0%(Week 0 to week 20.)
- Change from baseline to week 20 in fasting plasma glucose (FPG)(Week 0 to week 20.)
Investigators
Study Sites (2)
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