Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T1DM

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT04965051
Status
Unknown

Conditions

  • HbA1c
  • Time in Range
  • Type 1 Diabetes Mellitus With Diabetic Gastroparesis

Eligibility Criteria

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

Interventions

  • insulin degludec/insulin aspart (IDegAsp) — DRUG
    To evaluate the efficacy and safety of the IDegAsp in T1DM
  • basal insulin plus pre-prandial insulin — DRUG
    To evaluate the efficacy and safety of basal insulin plus pre-prandial insulin in T1DM

Study Details

In this prospective, randomized, open-label, parallel group trial, the safety and efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with basal insulin once or twice daily plus pre-prandial insulin after 16 weeks of treatment in patients with type 1 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in HbA1c and Time in Range (TIR).

Key Dates

Start date
Aug 31, 2021
Status verified
Jul 2021
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IDegAsp group
    IDegAsp twice daily
  • Active Comparator: basal insulin plus pre-prandial insulin group
    basal insulin once or twice daily plus pre-prandial insulin

Primary Outcome Measure

HbA1c [ Time Frame: 16 weeks ]

Central Contacts

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