A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China

Sponsor
Sunshine Lake Pharma Co., Ltd.
Study ID
NCT05802862
Phase
PHASE3
Status
Completed

Conditions

  • Diabetes

Eligibility Criteria

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

Interventions

  • Insulin Degludec and Insulin Aspart — DRUG
    administered subcutaneously, once a day

Study Details

The purpose of this study is to see if Insulin Degludec/Insulin Aspart (22011) compared to Insulin Degludec/Insulin Aspart (Ryzodeg) is similar in safety and effect in participants with type 2 diabetes (T2D).

Key Dates

Start date
Jul 6, 2023
Status verified
Mar 2023
Primary completion
Aug 16, 2024
Completion
Aug 16, 2024

Study Design

Enrollment
414 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 22011
  • Active Comparator: Ryzodeg

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline to Week 24 ]

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