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Simpler insulin regimen may work just as well for diabetes

NCT ID NCT05417841

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two ways of taking insulin in people with type 2 diabetes. One group took a mix of long- and fast-acting insulin twice a day. The other group took the mix once a day plus extra fast-acting insulin at meals. After 16 weeks, researchers compared blood sugar control and safety. The goal was to see if the simpler twice-daily schedule is just as effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Insulin degludec and insulin aspart (a mix of long- and fast-acting insulin)
What this could lead to
If successful, this could show that a simpler twice-daily insulin mix works as well as a more complex schedule, making diabetes management easier for patients.
What could go wrong
This is a completed trial with 218 participants, so results are available but not yet widely published. The benefit is about convenience, not a cure, and individual responses may vary.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

218 people

The number who actually took part.

Started

Mar 2023

Finished

Aug 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 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\. Informed consent has been obtained before any trial-related activities; * 2\. Patients aged 18\~75 years old (including 18 years old and 75 years old); * 3\. Clinical diagnosis of type 2 diabetes ≥ 6 months according to WHO diagnostic criteria before screening; * 4\. Use basal insulin once a day with or without other hypoglycemic drugs for at least 3 months before randomization; * 5\. Glycated hemoglobin between 7.0%\~10.0% within 3 month before randomization (including the critical value); * 6\. Body mass index (BMI)≤40.0kg/m2; Exclusion Criteria: * 1\. Suffering from type 1 diabetes, or special type of diabetes; * 2\. Known premixed insulin or IDegAsp used 3 month before randomization; * 3\. Changes in concomitant medications that are expected to significantly interfere with glucose metabolism; * 4\. Known or suspected subjects are allergic to test drugs, excipients or related similar products and excipients; * 5\. Cardiovascular and cerebrovascular disease, defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, stroke and/or myocardial infarction within 6 months before screening; or planned/coronary artery , carotid artery, peripheral artery revascularization; * 6\. According to the judgment of the investigator, repeated hypoglycemia perception impairment and severe hypoglycemia events occurred before screening; * 7\. Abnormal and clinically significant hemoglobin laboratory test results; * 8\. Hepatic insufficiency, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 times the upper limit of the normal range at screening; renal insufficiency, defined as (but not limited to) serum creatinine Levels ≥1.5mg/dL (132umol/L, men) and ≥1.4mg/dL (123umol/L, women), or massive proteinuria (\>2 g/day); * 9\. Uncontrolled/untreated hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) before randomization; * 10\. Two or more events of ketoacidosis or hyperglycemia and hyperosmolar state requiring hospitalization within 6 months prior to screening, or significant diabetic complications, such as symptomatic autonomic neuropathy, diabetic gastric mildew paralysis, proliferative retinopathy, etc. occured; * 11\. According to the judgment of the investigator, significant changes in lifestyle are expected during the trial period, such as shift work (including persistent night/evening shift work) and highly irregular diet and living habits; * 12\. Pregnant or breastfeeding women; those who have a pregnancy plan during the entire trial period and are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, contraceptive ring, partner ligation, etc.) during the trial; * 13\. Participate in any clinical trial within the past 3 months; * 14\. Those who are not suitable to participate in the trial according to the investigator's judgment, or any clinically significant disease or condition that the investigator believes may affect the results of the trial, such as: a history of hemolytic anemia or sickle cell anemia, a previous history of tumor or cancer Patients with a medical history, patients with a known history of alcohol, drug or drug abuse, blood transfusions or severe blood loss within the first 3 months of screening, or patients with poor adherence in the judgment of the investigator.

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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.

Contacts and locations

Locations

  • Aerospace general hospital

    Beijing, China

  • Beijing Boai Hospital

    Beijing, China

  • Beijing Hospital

    Beijing, China

  • Hebei General Hospital

    Shijiazhuang, Hebei, China

  • Jilin University Sino-Japanese Friendship Hospital

    Changchun, Jilin, China

  • Peking university shougang hospital

    Beijing, China

  • The Second Affiliated Medical College of Xi'an Jiaotong University

    Xi'an, Shaanxi, China

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