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.
The objective of the current study is to investigate the efficacy and safety of IDegAsp twice daily compared with IDegAsp once daily plus IAsp twice daily for 16 weeks in patients with type 2 diabetes mellitus. The primary endpoint in this study is the change from baseline in HbA1c. Patients with type 2 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 224 patients will be enrolled in the study. Patients who qualify will be randomized to IDegAsp group or IDegAsp + IAsp group. Duration of treatment includes 3-week screening period, 16-week treatment observation period and 1-week follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
218
To evaluate the efficacy and safety of the IDegAsp BID in T2DM
To evaluate the efficacy and safety of the IDegAsp QD plus IAsp BID in T2DM
Hebei General Hospital
Shijiazhuang, Hebei, China
Jilin University Sino-Japanese Friendship Hospital
Changchun, Jilin, China
The Second Affiliated Medical College of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Aerospace general hospital
Beijing, China
HbA1c
the change from baseline in HbA1c after 16 weeks of treatment in all patients
Time frame: 16 weeks
HbA1c response
the percentage of patients with HbA1c \< 7.0% in patients without definite hypoglycemia after 16 weeks of treatment
Time frame: 16 weeks
Body weight
the body weight change from baseline after 16 weeks of treatment
Time frame: 16 weeks
Fasted Blood Glucose
the change from baseline in fasting blood glucose after 16 weeks of treatment
Time frame: 16 weeks
7-Point Self-monitoring Blood Glucose
the change from baseline in 7-point self-monitoring blood glucose profile after 16 weeks of treatment
Time frame: 16 weeks
Continuous Glucose Monitoring
the change from Baseline in Mean Glucose of CGM at Weeks 14-16 of Treatment
Time frame: 14-16 weeks
Percentage of Time In Range
the change from Baseline in Percentage of Readings in Target Range for Blood Glucose Values at Weeks 14-16 of Treatment
Time frame: 14-16 weeks
Percentage of Time Below Range
the change from Baseline in Percentage of Readings below Target Range for Blood Glucose Values at Weeks 14-16 of Treatment
Time frame: 14-16 weeks
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Beijing Boai Hospital
Beijing, China
Beijing Hospital
Beijing, China
Peking university shougang hospital
Beijing, China
Percentage of Time Above Range
the change from Baseline in Percentage of Readings above Target Range for Blood Glucose Values at Weeks 14-16 of Treatment
Time frame: 14-16 weeks
Glucose Management Indicator
the change from Baseline in estimated HbA1c at Weeks 14-16 of Treatment
Time frame: 14-16 weeks
Glucose Variability
Change from Baseline in Glucose Variability (Coefficient of Variation) of CGM at Weeks 14-16 of Treatment
Time frame: 14-16 weeks
Time In Range
the change from Baseline of time in Target Range for Blood Glucose Values at Weeks 14-16 of Treatment
Time frame: 14-16 weeks
Time Below Range
the change from Baseline of time below Target Range for Blood Glucose Values at Weeks 14-16 of Treatment
Time frame: 14-16 weeks
Time Above Range
the change from Baseline of time above Target Range for Blood Glucose Values at Weeks 14-16 of Treatment
Time frame: 14-16 weeks