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Type 2 Diabetes MellitusNCT05417841

Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T2DM

A study testing Insulin Degludec and Insulin Aspart Injection and Insulin Aspart Injection in people with Type 2 Diabetes Mellitus, run by Beijing Hospital at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this multicenter, randomized, open-label, parallel-controlled, non-inferiority clinical trial, the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with degludec/insulin aspart (IDegAsp) once daily plus insulin aspart (IAsp) twice daily after 16weeks of treatment in… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Insulin Degludec and Insulin Aspart Injection and Insulin Aspart Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
7 sitesChina
Study dates
23 Mar 2023to 15 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Aerospace general hospital

    Beijing

  • Beijing Boai Hospital

    Beijing

  • Beijing Hospital

    Beijing

  • Peking university shougang hospital

    Beijing

  • Jilin University Sino-Japanese Friendship Hospital

    Changchun, Jilin

  • Hebei General Hospital

    Shijiazhuang, Hebei

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

    Xi'an, Shaanxi

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open, Parallel-controlled Clinical Trial to Compare the Efficacy and Safety of IDegAsp BID and IDegAsp QD+2IAsp in Patients With Type 2 Diabetes Mellitus

In this multicenter, randomized, open-label, parallel-controlled, non-inferiority clinical trial, the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with degludec/insulin aspart (IDegAsp) once daily plus insulin aspart (IAsp) twice daily after 16weeks of treatment in patients with type 2 diabetes mellitus. This trial will enable primary assessment of the clinically relevant endpoint of a change in HbA1c.

Read the detailed description

The objective of the current study is to investigate the efficacy and safety of IDegAsp twice daily compared with IDegAsp once daily plus IAsp twice daily for 16 weeks in patients with type 2 diabetes mellitus. The primary endpoint in this study is the change from baseline in HbA1c. Patients with type 2 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 224 patients will be enrolled in the study. Patients who qualify will be randomized to IDegAsp group or IDegAsp + IAsp group. Duration of treatment includes 3-week screening period, 16-week treatment observation period and 1-week follow-up.

Being tested
Insulin Degludec and Insulin Aspart Injection, Insulin Aspart Injection
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.

  • Insulin Degludec and Insulin Aspart InjectionDrug

    Also called Ryzodeg®

    To evaluate the efficacy and safety of the IDegAsp BID in T2DM

  • Insulin Aspart InjectionDrug

    Also called NovoRapid®

    To evaluate the efficacy and safety of the IDegAsp QD plus IAsp BID in T2DM

Study groups in NCT05417841
Study groupRoleWhat they receive
IDegAsp groupExperimentalIDegAsp twice daily
Receives: Drug: Insulin Degludec and Insulin Aspart Injection
IDegAsp + IAsp groupActive comparatorIDegAsp once daily plus IAsp twice daily
Receives: Drug: Insulin Degludec and Insulin Aspart Injection; Drug: Insulin Aspart Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    the change from baseline in HbA1c after 16 weeks of treatment in all patients

    Measured: 16 weeks

Secondary outcomes (13)

  1. HbA1c response

    the percentage of patients with HbA1c < 7.0% in patients without definite hypoglycemia after 16 weeks of treatment

    Measured: 16 weeks

  2. Body weight

    the body weight change from baseline after 16 weeks of treatment

    Measured: 16 weeks

  3. Fasted Blood Glucose

    the change from baseline in fasting blood glucose after 16 weeks of treatment

    Measured: 16 weeks

  4. 7-Point Self-monitoring Blood Glucose

    the change from baseline in 7-point self-monitoring blood glucose profile after 16 weeks of treatment

    Measured: 16 weeks

  5. Continuous Glucose Monitoring

    the change from Baseline in Mean Glucose of CGM at Weeks 14-16 of Treatment

    Measured: 14-16 weeks

  6. Percentage of Time In Range

    the change from Baseline in Percentage of Readings in Target Range for Blood Glucose Values at Weeks 14-16 of Treatment

    Measured: 14-16 weeks

  7. Percentage of Time Below Range

    the change from Baseline in Percentage of Readings below Target Range for Blood Glucose Values at Weeks 14-16 of Treatment

    Measured: 14-16 weeks

  8. Percentage of Time Above Range

    the change from Baseline in Percentage of Readings above Target Range for Blood Glucose Values at Weeks 14-16 of Treatment

    Measured: 14-16 weeks

  9. Glucose Management Indicator

    the change from Baseline in estimated HbA1c at Weeks 14-16 of Treatment

    Measured: 14-16 weeks

  10. Glucose Variability

    Change from Baseline in Glucose Variability (Coefficient of Variation) of CGM at Weeks 14-16 of Treatment

    Measured: 14-16 weeks

  11. Time In Range

    the change from Baseline of time in Target Range for Blood Glucose Values at Weeks 14-16 of Treatment

    Measured: 14-16 weeks

  12. Time Below Range

    the change from Baseline of time below Target Range for Blood Glucose Values at Weeks 14-16 of Treatment

    Measured: 14-16 weeks

  13. Time Above Range

    the change from Baseline of time above Target Range for Blood Glucose Values at Weeks 14-16 of Treatment

    Measured: 14-16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2022
  2. Study start23 Mar 2023
  3. Primary completion15 Aug 2025
  4. Study completion15 Aug 2025

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05417841
Sponsor's protocol ID
MLD-C-21003
Status last verified
Nov 2025
First submitted
8 Jun 2022
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We plan not to make individual participant data (IPD) available to other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Insulin Degludec and Insulin Aspart Injection and Insulin Aspart Injection in people with Type 2 Diabetes Mellitus, run by Beijing Hospital at 7 sites in China.

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 6 inclusion and 14 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: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

HbA1c (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05417841.

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 3 Dec 2025.

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