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

NCT05417841 | Completed

• 1 other identifier: MLD-C-21003
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 7

Brief 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 patients with type 2 diabetes mellitus. This trial will enable primary assessment of the clinically relevant endpoint of a change in HbA1c.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

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

  16 weeks

Secondary Outcomes (13)

• HbA1c response

  16 weeks

• Body weight

  16 weeks

• Fasted Blood Glucose

  16 weeks

• 7-Point Self-monitoring Blood Glucose

  16 weeks

• Continuous Glucose Monitoring

  14-16 weeks

Study Arms (2)

IDegAsp group

EXPERIMENTAL

IDegAsp twice daily

Drug: Insulin Degludec and Insulin Aspart Injection

IDegAsp + IAsp group

ACTIVE COMPARATOR

IDegAsp once daily plus IAsp twice daily

Drug: Insulin Degludec and Insulin Aspart Injection; Drug: Insulin Aspart Injection

Interventions

Insulin Aspart Injection DRUG

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

Also known as: NovoRapid®

IDegAsp + IAsp group

Insulin Degludec and Insulin Aspart Injection DRUG

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

Also known as: Ryzodeg®

IDegAsp + IAsp group; IDegAsp group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Informed consent has been obtained before any trial-related activities;
• \. Patients aged 18\~75 years old (including 18 years old and 75 years old);
• \. Clinical diagnosis of type 2 diabetes ≥ 6 months according to WHO diagnostic criteria before screening;
• \. Use basal insulin once a day with or without other hypoglycemic drugs for at least 3 months before randomization;
• \. Glycated hemoglobin between 7.0%\~10.0% within 3 month before randomization (including the critical value);
• \. Body mass index (BMI)≤40.0kg/m2;

You may not qualify if:

• \. Suffering from type 1 diabetes, or special type of diabetes;
• \. Known premixed insulin or IDegAsp used 3 month before randomization;
• \. Changes in concomitant medications that are expected to significantly interfere with glucose metabolism;
• \. Known or suspected subjects are allergic to test drugs, excipients or related similar products and excipients;
• \. 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;
• \. According to the judgment of the investigator, repeated hypoglycemia perception impairment and severe hypoglycemia events occurred before screening;
• \. Abnormal and clinically significant hemoglobin laboratory test results;
• \. 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);
• \. Uncontrolled/untreated hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) before randomization;
• \. 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;
• \. 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;
• \. 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;
• \. Participate in any clinical trial within the past 3 months;
• \. 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.

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (7)

Hebei General Hospital

Shijiazhuang, Hebei, China

Location

Jilin University Sino-Japanese Friendship Hospital

Changchun, Jilin, China

Location

The Second Affiliated Medical College of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

Aerospace general hospital

Beijing, China

Location

Beijing Boai Hospital

Beijing, China

Location

Beijing Hospital

Beijing, China

Location

Peking university shougang hospital

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec, insulin aspart drug combination; Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 14, 2022
• Study Start: March 23, 2023
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)