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

Sponsor
Beijing Hospital
Study ID
NCT05417841
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Insulin Degludec and Insulin Aspart Injection — DRUG
    To evaluate the efficacy and safety of the IDegAsp BID in T2DM
  • Insulin Aspart Injection — DRUG
    To evaluate the efficacy and safety of the IDegAsp QD plus IAsp BID in T2DM

Study Details

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.

Key Dates

Start date
Mar 23, 2023
Status verified
Nov 2025
Primary completion
Aug 15, 2025
Completion
Aug 15, 2025

Study Design

Enrollment
218 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IDegAsp group
    IDegAsp twice daily
  • Active Comparator: IDegAsp + IAsp group
    IDegAsp once daily plus IAsp twice daily

Primary Outcome Measure

HbA1c [ Time Frame: 16 weeks ]

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