New insulin option shows promise for diabetes control
NCT ID NCT05802862
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new insulin (22011) to see if it works as well as an existing insulin (Ryzodeg) for people with type 2 diabetes. About 414 adults in China took part. The goal was to compare blood sugar control and safety. Results suggest the new insulin is a similar option for managing diabetes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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414 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Aug 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sunshine Lake Pharma Co., Ltd.
Dongguan, Guangdong, 523000, China
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