Simpler insulin regimen may work just as well for diabetes
NCT ID NCT05417841
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
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218 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Aug 2025
- Lead sponsor
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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
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18 to 75 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\. 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
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Aerospace general hospital
Beijing, China
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Beijing Boai Hospital
Beijing, China
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Beijing Hospital
Beijing, China
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Hebei General Hospital
Shijiazhuang, Hebei, China
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Jilin University Sino-Japanese Friendship Hospital
Changchun, Jilin, China
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Peking university shougang hospital
Beijing, China
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The Second Affiliated Medical College of Xi'an Jiaotong University
Xi'an, Shaanxi, China
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