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New study aims to find best Long-Term insulin plan after intensive therapy for type 2 diabetes

NCT ID NCT07173712

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 324 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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  1. The official record

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