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NCT05802862 | NOT YET RECRUITING | Diabetes

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.

Brief Summary:

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).

Condition or disease

Diabetes

Intervention/treatment

Insulin Degludec and Insulin Aspart

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 408 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Multi-center, Randomized, Open, Phase III Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared Efficacy and Safety With Insulin Degludec/Insulin Aspart(Ryzodeg) in Chinese Subjects With Type 2 Diabetes
Actual Study Start Date : 2023-05-01
Estimated Primary Completion Date : 2023-12-01
Estimated Study Completion Date : 2024-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Informed consent obtained before any trial-related activities.
  • * Male or female, age at least 18 year-old and no more than 75 year-old at the time of signing informed consent.
  • * Type 2 diabetes mellitus (T2D).
  • * Body mass index (BMI) higher than 18.0, but below or equal to 35.0 kg/m\^2.
  • * Current treatment for at least 3 months prior to screening with basal insulin/premixed insulin once a day or twice a day with/without oral anti-diabetic drugs (OADs): metformin, alpha-glucosidase inhibitors, dimethylphenylpenicillin dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-dependent glucose transporter 2 (SGLT-2) inhibitors . For above or equal to 3 months prior to screening subjects should be on a stable dose.
  • * HbA1c from 7-11.0% both inclusive at screening confirmed by central laboratory analysis.
Exclusion Criteria
  • * Have a diagnosis of type 1 diabetes (T1D), or specific type of diabetes other than T2D, for example, injured pancreas, diseases of acromegaly-induced diabetes.
  • * Have a history of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
  • * Have had severe hypoglycemia episodes within 6 months prior to screening.
A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China

Location Details

NCT05802862

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How to Participate

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Locations

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