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

NCT05417841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2025-12-03

No results posted yet for this study

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

Interventions

DRUG

Insulin Degludec and Insulin Aspart Injection

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

DRUG

Insulin Aspart Injection

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

Sponsors & Collaborators

  • Beijing Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-23
Primary Completion
2025-08-15
Completion
2025-08-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05417841 on ClinicalTrials.gov