Status:
NOT_YET_RECRUITING
Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes
Lead Sponsor:
Yanbing Li
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Failure of oral antidiabetic drugs (OADs) is a frequent challenge in patients with type 2 diabetes mellitus (T2DM), and inadequate long-term glycemic control substantially increases the risk of diabet...
Eligibility Criteria
Inclusion
- Diagnosed with type 2 diabetes mellitus (T2DM) with a disease duration of \>1 year and \<15 years.
- On a stable dose of at least one oral antidiabetic drug (OAD) for ≥3 months.
- HbA1c at screening: \>8.0% if on a single OAD; \>7.5% if on more than one OAD (centralized laboratory testing, or results from medical centers participating in the National Glycohemoglobin Standardization Program).
- Age 18-70 years.
- Body mass index (BMI) 20-35 kg/m².
- Able and willing to comply with study requirements, including continuous glucose monitoring, self-monitoring of blood glucose, lifestyle management, and insulin-based glycemic management.
- Agreement to use effective contraception during the study.
- Willingness to provide written informed consent.
Exclusion
- Diagnosis of type 1 diabetes mellitus or other specific types of diabetes.
- Receipt within 3 months prior to screening of premixed insulin therapy and/or basal-bolus insulin therapy and/or basal insulin plus OAD therapy for ≥7 cumulative days; or receipt within 1 year prior to screening of intensive insulin therapy (insulin pump or multiple daily injections); or receipt within 3 months prior to screening of GLP-1 receptor agonists; or inability to tolerate protocol-specified doses.
- Known hypersensitivity or intolerance to study medications.
- Acute diabetic complications (including diabetic ketoacidosis, hyperosmolar hyperglycemic state, or lactic acidosis).
- Severe microvascular complications: proliferative diabetic retinopathy; albumin excretion rate (AER) \>300 mg/g or proteinuria \>0.5 g/day; uncontrolled painful diabetic neuropathy or significant autonomic neuropathy. Severe macrovascular complications: hospitalization for acute cerebrovascular accident, acute coronary syndrome, peripheral artery disease requiring intervention or amputation within the previous 12 months; unstable angina, myocardial infarction, uncontrolled arrhythmia, or severe heart failure (New York Heart Association \[NYHA\] class ≥III).
- Persistent blood pressure \>180/110 mmHg, or uncontrolled above 160/110 mmHg within 1 week.
- Estimated creatinine clearance \<45 mL/min/1.73 m² (calculated by CKD-EPI formula); alanine aminotransferase ≥2.5 × upper limit of normal (ULN); or total bilirubin ≥1.5 × ULN.
- Hemoglobin \<100 g/L or requiring regular blood transfusions.
- Use within 12 weeks prior to screening of medications affecting glycemic control for \>1 cumulative week, including oral/intravenous glucocorticoids, growth hormone, estrogen/progestins, high-dose diuretics, or antipsychotics. Exceptions: low-dose diuretics used for antihypertensive purposes (HCTZ \<25 mg/day, indapamide ≤1.5 mg/day) and physiological thyroid hormone replacement therapy.
- Uncontrolled endocrine disorders.
- History or family history of medullary thyroid carcinoma, or history of multiple endocrine neoplasia syndrome type 2 (MEN2).
- Psychiatric illness or communication disorders.
- Systemic infection, severe comorbid conditions, malignancy, or chronic diarrhea.
- Pregnancy, lactation, or women of childbearing potential unwilling to use contraception during the study.
- Uncooperative participants, inability to comply with follow-up, or judged by investigators as unlikely to complete the study.
- Any other condition deemed unsuitable by investigators, including history of acute pancreatitis, rapidly progressing gallstones, or chronic cholecystitis.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT07173712
Start Date
October 1 2025
End Date
December 31 2027
Last Update
September 15 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.