← Trials/Trial dossier/NCT07173712

Not yet recruitingPhase 4

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

Yanbing Li

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

Enrollment

324

estimated

Study population

Type 2 diabetes

Key I/E criteria

BMI 20-35HbA1c ≥8%

Primary endpoint

HbA1c <7.0% achievement

Identifiers

Registered as

NCT IDNCT07173712
Org study IDIIT-2025-182

Timeline

Milestones

Study first posted2025-09-15actual
Last update posted2026-02-06actual
Study start2026-03-15estimated
Primary completion2027-06-30estimated
Study completion2027-12-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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
Safety / tolerability / PK
2

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Proportion of subjects with optimal glycemic control

Time frame:24 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of subjects with excellent glycemic control

Time frame:24 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of subjects with glycemic control

Time frame:48 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Medication Compliance

Time frame:48 weeks

threshold achievement, descriptive

Secondary/protocol endpoint

Incidence of adverse events

Time frame:24 weeks and 48 weeks

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.