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).
The objective of the current study is to investigate the efficacy and safety of IDegAsp twice daily compared to basal insulin once or twice daily plus pre-prandial insulin for 16 weeks in patients with type 1 diabetes mellitus. The primary endpoint in this study is the change from baseline in HbA1c. Patients with type 1 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 40 patients will be enrolled in the study. Patients who qualify will be randomized to IDegAsp group or basal plus pre-prandial insulin group. Duration of treatment includes 2-week screening period, 16-week treatment observation period and 1-week follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
To evaluate the efficacy and safety of the IDegAsp in T1DM
To evaluate the efficacy and safety of basal insulin plus pre-prandial insulin in T1DM
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGHbA1c
the change from baseline in HbA1c after 16 weeks of treatment in all patients
Time frame: 16 weeks
Time In Range (TIR)
The change from baseline in Time in Range (3.9-10mmol/L) after 16 weeks of treatment in all patients (using flash continuous glucose monitoring (FCGM)).
Time frame: 16 weeks
Time to occurrence of treat to target
Fasting glucose on treatment \<7mmol/L and non-fasting glucose \<10mmol/L, or TIR \>70%) (SMBG or FCGM)
Time frame: 16 weeks
Occurrence of a treat to target response and without any hypoglycemic episodes
Occurrence of a treat to target response and without any hypoglycemic episodes
Time frame: 16 weeks
EQ-5D Health Questionnaire
the EQ-5D descriptive system The change from baseline after 16 weeks of treatment
Time frame: 16 weeks
Short Form 36 (SF-36)
The change from baseline after 16 weeks of treatment
Time frame: 16 weeks
Insulin dose
The change from baseline after 16 weeks of treatment
Time frame: 16 weeks
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