| Trial ID: | L4460 |
| Source ID: | NCT05417841
|
| Associated Drug: |
Insulin Degludec And Insulin Aspart Injection
|
| Title: |
Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T2DM
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin Degludec and Insulin Aspart Injection|DRUG: Insulin Aspart Injection
|
| Outcome Measures: |
Primary: HbA1c, the change from baseline in HbA1c after 16 weeks of treatment in all patients, 16 weeks | Secondary: HbA1c response, the percentage of patients with HbA1c \< 7.0% in patients without definite hypoglycemia after 16 weeks of treatment, 16 weeks|Body weight, the body weight change from baseline after 16 weeks of treatment, 16 weeks|Fasted Blood Glucose, the change from baseline in fasting blood glucose after 16 weeks of treatment, 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, 16 weeks|Continuous Glucose Monitoring, the change from Baseline in Mean Glucose of CGM at Weeks 14-16 of Treatment, 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, 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, 14-16 weeks|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, 14-16 weeks|Glucose Management Indicator, the change from Baseline in estimated HbA1c at Weeks 14-16 of Treatment, 14-16 weeks|Glucose Variability, Change from Baseline in Glucose Variability (Coefficient of Variation) of CGM at Weeks 14-16 of Treatment, 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, 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, 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, 14-16 weeks
|
| Sponsor/Collaborators: |
Sponsor: Beijing Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
224
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-07-01
|
| Completion Date: |
2024-07-31
|
| Results First Posted: |
|
| Last Update Posted: |
2022-06-15
|
| Locations: |
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|Beijing Boai Hospital, Beijing, China|Beijing Hospital, Beijing, China|Civil Aviation General Hospital, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05417841
|
