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Clinical Trial Details

Trial ID: L2747
Source ID: NCT05802862
Associated Drug: Insulin Degludec And Insulin Aspart
Title: A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes
Interventions: DRUG: Insulin Degludec and Insulin Aspart
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (HbA1c), HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time, Baseline to Week 24 | Secondary: Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12, HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time, Baseline to Week12|Percentage of Participant Who Achieved HbA1c<7% and ≤6.5%, the ratio of participant Who Achieved HbA1c\<7% and ≤6.5%, Baseline to Week24|Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes, The ratio of participant Who Achieved HbA1c\<7% and ≤6.5% without Hypoglycaemic Episodes, Baseline to Week24|Change From Baseline in Fasting Plasma Glucose(FPG), the plasma glucose concentration on an empty stomach, Baseline to Week12|Change From Baseline in Fasting Plasma Glucose(FPG) in Week24, the plasma glucose concentration on an empty stomach, Baseline to Week24|Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values, SMBG 7-point profiles were measured at fasting, 2-hour post morning meal, pre midday meal, 2-hour post midday meal, pre evening meal, 2-hours post evening meal, and bedtime., Baseline to Week12|Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values in Week24, SMBG 7-point profiles were measured at fasting, 2-hour post morning meal, pre midday meal, 2-hour post midday meal, pre evening meal, 2-hours post evening meal, and bedtime., Baseline to Week24|Change From Baseline in Body weight, Change in body weight, Baseline to Week24|Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE), Safety, from baseline to Week25
Sponsor/Collaborators: Sponsor: Sunshine Lake Pharma Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 408
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-01
Completion Date: 2024-03-01
Results First Posted:
Last Update Posted: 2023-04-07
Locations:
URL: https://clinicaltrials.gov/show/NCT05802862