Clinical trial NCT07018453: A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
Official title: A Randomized, Open-label, Treat-to-target, Parallel-Controlled Phase II Clinical Study Investigating the Efficacy and Safety of SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-12
Enrollment: 153
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 glycemic control and safety of SHR-3167 and Insulin Degludec in type 2 diabetic participants treated with basal insulin with or without oral antidiabetic drugs.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in glycosylated hemoglobin (HbA1c) from baseline.
timeFrame: 16 weeks.
Secondary outcomes:
measure: Proportion of subjects with glycosylated hemoglobin (HbA1c) < 7.0% from baseline.
timeFrame: 16 weeks.
measure: Change in fasting plasma glucose (FPG) from baseline.
timeFrame: 16 weeks.
measure: Change in self-measured (capillary) blood glucose (SMBG) from baseline.
timeFrame: 16 weeks.
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
References: