Clinical trial NCT06688123: Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-14
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Change from baseline to week 20 in HbA1c (HemoglobinA1c)
timeFrame: Week 0 to week 20.
Secondary outcomes:
measure: Percentage of participants achieving HbA1c<7.0%
timeFrame: Week 0 to week 20.
measure: Change from baseline to week 20 in fasting plasma glucose (FPG)
timeFrame: Week 0 to week 20.
measure: Change from baseline to week 20 in self-measured blood glucose (SMBG) before breakfast
timeFrame: Week 0 to week 20.
measure: Number of adverse events (AEs) during the trial
timeFrame: Week 0 to week 24.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
Study officials:
References: