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Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes
Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Hypoglycemic Agents: A Multicenter, Open-Label, Randomized Controlled Study
Lead sponsor
Asset
Lixisenatide
Subcutaneous · GLP-1 agonist
Listed sites
0
Recruiting sites
—
Enrollment
324
estimated
Study population
Type 2 diabetes
Key I/E criteria
•BMI 20-35•HbA1c ≥8%
Primary endpoint
•HbA1c <7.0% achievement
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Diagnosed with type 2 diabetes mellitus (T2DM) with a disease duration of >1 year and <15 years.
2. On a stable dose of at least one oral antidiabetic drug (OAD) for ≥3 months.
3. 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).
4. Age 18-70 years.
5. Body mass index (BMI) 20-35 kg/m².
6. Able and willing to comply with study requirements, including continuous glucose monitoring, self-monitoring of blood glucose, lifestyle management, and insulin-based glycemic management.
7. Agreement to use effective contraception during the study.
8. Willingness to provide written informed consent.
Exclusion criteria
1. Diagnosis of type 1 diabetes mellitus or other specific types of diabetes.
2. 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.
3. Known hypersensitivity or intolerance to study medications.
4. Acute diabetic complications (including diabetic ketoacidosis, hyperosmolar hyperglycemic state, or lactic acidosis).
5. 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).
6. Persistent blood pressure >180/110 mmHg, or uncontrolled above 160/110 mmHg within 1 week.
7. 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.
8. Hemoglobin <100 g/L or requiring regular blood transfusions.
9. 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.
10. Uncontrolled endocrine disorders.
11. History or family history of medullary thyroid carcinoma, or history of multiple endocrine neoplasia syndrome type 2 (MEN2).
12. Psychiatric illness or communication disorders.
13. Systemic infection, severe comorbid conditions, malignancy, or chronic diarrhea.
14. Pregnancy, lactation, or women of childbearing potential unwilling to use contraception during the study.
15. Uncooperative participants, inability to comply with follow-up, or judged by investigators as unlikely to complete the study.
16. Any other condition deemed unsuitable by investigators, including history of acute pancreatitis, rapidly progressing gallstones, or chronic cholecystitis.
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
3 endpointsProportion of subjects with optimal glycemic control
Time frame:24 weeks
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Proportion of subjects with excellent glycemic control
Time frame:24 weeks
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Proportion of subjects with glycemic control
Time frame:48 weeks
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Safety / tolerability / PK
2 endpointsMedication Compliance
Time frame:48 weeks
threshold achievement, descriptive
Incidence of adverse events
Time frame:24 weeks and 48 weeks
Treatment-emergent AEs (any)
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.