New study aims to find best Long-Term insulin plan after intensive therapy for type 2 diabetes
NCT ID NCT07173712
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study enrolls 324 adults with type 2 diabetes whose blood sugar is not well controlled on oral medications. All participants will first receive short-term intensive insulin therapy in the hospital. Then, they will be randomly assigned to one of three insulin-based regimens for 24 weeks: a combination insulin and GLP-1 drug, a mixed insulin, or long-acting insulin plus metformin. The goal is to see which approach best helps patients achieve and maintain healthy blood sugar levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Insulin glargine/lixisenatide, insulin degludec/aspart, insulin glargine U300, and metformin
- What this could lead to
- If successful, this study could identify a simple and effective long-term treatment plan after short-term intensive insulin therapy for people with type 2 diabetes who are not well controlled on oral medications.
- What could go wrong
- This is a phase 4 trial, so the drugs are already approved, but the best follow-up regimen is unknown. Results may not apply to all patients, and side effects like hypoglycemia or weight gain are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 324 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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