Type 2 DiabetesPhase 4NCT07173712
Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes
A Phase 4 study testing CSII, Insulin glargine /lixisenatide Fixed Ratio Combination and Insulin Degludec and Insulin Aspart Injection in people with Type 2 Diabetes, run by Yanbing Li.
Trial 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 diabetic complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CSII, Insulin glargine /lixisenatide Fixed Ratio Combination and Insulin Degludec and Insulin Aspart Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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
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 diabetic complications. Short-term intensive insulin therapy (SIIT) is an established approach to mitigate glucotoxicity; however, the optimal strategy to sustain long-term glycemic benefits after SIIT in T2DM patients with OAD failure remains unclear. To address this gap, we designed a randomized controlled trial to evaluate subsequent treatment options, aiming to identify a simple and effective regimen for patients with poor glycemic control who undergo SIIT.
A total of 324 eligible patients will be enrolled. After screening, previous antidiabetic regimens will be discontinued, and patients will be randomly assigned to the SIIT- iGlarLixi group (A), the SIIT-IDegAsp group (B), or the SIIT-iGlar group (C). All patients will be hospitalized for short-term insulin pump therapy, followed by 24 weeks of treatment: group A with insulin glargine/lixisenatide, group B with insulin degludec/aspart, and group C with insulin glargine U300 plus metformin. During the extension follow-up period, patients in all groups may either continue their assigned regimen or return to their original pre-study therapy. A total of 10 clinic visits are scheduled for each patient throughout the study.
Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C <7% at 24 weeks.Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C <6.5% at 24 weeks; differences in weight gain, hypoglycemic events among treatment groups, and differences in proportion of patients continuing the assigned regimen, glycemic control and body weight at the extension follow-up period.
- Conditions
- Type 2 Diabetes
- Being tested
- CSII, Insulin glargine /lixisenatide Fixed Ratio Combination, Insulin Degludec and Insulin Aspart Injection, Insulin Glargine (HOE901 - U300), Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSIIDrug
Short term intensive insulin therapy
Insulin glargine /lixisenatide Fixed Ratio CombinationDrug
Insulin Glargine and Lixisenatide Injection(I) Treatment for 24 weeks
Insulin Degludec and Insulin Aspart InjectionDrug
Insulin Degludec and Insulin Aspart Injection Treatment for 24 weeks
Insulin Glargine (HOE901 - U300)Drug
Insulin Glargine Treatment for 24 Weeks
MetforminDrug
Metformin Treatment for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| iGlarLixi group | Active comparator | Not described Receives: Drug: CSII; Drug: Insulin glargine /lixisenatide Fixed Ratio Combination |
| IDegAsp group | Active comparator | Not described Receives: Drug: CSII; Drug: Insulin Degludec and Insulin Aspart Injection |
| iGlar group | Active comparator | Not described Receives: Drug: Insulin Glargine (HOE901 - U300); Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with optimal glycemic control
proportion of patients achieving glycosylated hemoglobin A1C <7% at 24 weeks in each treatment group.
Measured: 24 weeks
Secondary outcomes (4)
Proportion of subjects with excellent glycemic control
proportion of patients achieving glycosylated hemoglobin A1C <6.5% at 24 weeks in each treatment group.
Measured: 24 weeks
Proportion of subjects with glycemic control
proportion of patients achieving glycosylated hemoglobin A1C <7% and <6.5% at 48 weeks in each treatment group.
Measured: 48 weeks
Medication Compliance
differences in proportion of patients continuing the assigned regimen at 48 weeks in each treatment group.
Measured: 48 weeks
Incidence of adverse events
differences in incident of weight gain, hypoglycemic events among treatment groups at 24 weeks and extension follow-up period.
Measured: 24 weeks and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Mar 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanbing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanbing Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173712
- Sponsor's protocol ID
- IIT-2025-182
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07173712
- Acronym / sponsor ID
- IIT-2025-182
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Yanbing LiUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 diabetic complications. Short-term intensive insulin therapy (SIIT) is an established approach to mitigate glucotoxicity; however, the optimal strategy to sustain long-term glycemic benefits after SIIT in T2DM patients with OAD failure remains unclear. To address this gap, we designed a randomized controlled trial to evaluate subsequent treatment options, aiming to identify a simple and effective regimen for patients with poor glycemic control who undergo SIIT.
A total of 324 eligible patients will be enrolled. After screening, previous antidiabetic regimens will be discontinued, and patients will be randomly assigned to the SIIT- iGlarLixi group (A), the SIIT-IDegAsp group (B), or the SIIT-iGlar group (C). All patients will be hospitalized for short-term insulin pump therapy, followed by 24 weeks of treatment: group A with insulin glargine/lixisenatide, group B with insulin degludec/aspart, and group C with insulin glargine U300 plus metformin. During the extension follow-up period, patients in all groups may either continue their assigned regimen or return to their original pre-study therapy. A total of 10 clinic visits are scheduled for each patient throughout the study.
Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C <7% at 24 weeks.Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C <6.5% at 24 weeks; differences in weight gain, hypoglycemic events among treatment groups, and differences in proportion of patients continuing the assigned regimen, glycemic control and body weight at the extension follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iGlarLixi group | Active comparator | Drug: CSII, Drug: Insulin glargine /lixisenatide Fixed Ratio Combination |
| IDegAsp group | Active comparator | Drug: CSII, Drug: Insulin Degludec and Insulin Aspart Injection |
| iGlar group | Active comparator | Drug: Insulin Glargine (HOE901 - U300), Drug: Metformin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSIIShort term intensive insulin therapy | Drug | IDegAsp group, iGlarLixi group |
| Insulin glargine /lixisenatide Fixed Ratio CombinationInsulin Glargine and Lixisenatide Injection(I) Treatment for 24 weeks | Drug | iGlarLixi group |
| Insulin Degludec and Insulin Aspart InjectionInsulin Degludec and Insulin Aspart Injection Treatment for 24 weeks | Drug | IDegAsp group |
| Insulin Glargine (HOE901 - U300)Insulin Glargine Treatment for 24 Weeks | Drug | iGlar group |
| MetforminMetformin Treatment for 24 weeks | Drug | iGlar group |
Primary outcome
Proportion of subjects with optimal glycemic control
Time frame: 24 weeks
proportion of patients achieving glycosylated hemoglobin A1C <7% at 24 weeks in each treatment group.
4 secondary outcomes
Proportion of subjects with excellent glycemic control
Time frame: 24 weeks
Proportion of subjects with glycemic control
Time frame: 48 weeks
Medication Compliance
Time frame: 48 weeks
Incidence of adverse events
Time frame: 24 weeks and 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CSII, Insulin glargine /lixisenatide Fixed Ratio Combination and Insulin Degludec and Insulin Aspart Injection in people with Type 2 Diabetes, run by Yanbing Li.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with optimal glycemic control (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.