A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 22011
|
Drug: Insulin Degludec and Insulin Aspart
administered subcutaneously, once a day
|
| Active Comparator: Ryzodeg
|
Drug: Insulin Degludec and Insulin Aspart
administered subcutaneously, once a day
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Hemoglobin A1c (HbA1c) [Baseline to Week 24]
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time
Secondary Outcome Measures
- Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12 [Baseline to Week12]
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time
- Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% [Baseline to Week24]
the ratio of participant Who Achieved HbA1c<7% and ≤6.5%
- Percentage of Participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes [Baseline to Week24]
The ratio of participant Who Achieved HbA1c<7% and ≤6.5% without Hypoglycaemic Episodes
- Change From Baseline in Fasting Plasma Glucose(FPG) [Baseline to Week12]
the plasma glucose concentration on an empty stomach
- Change From Baseline in Fasting Plasma Glucose(FPG) in Week24 [Baseline to Week24]
the plasma glucose concentration on an empty stomach
- Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values [Baseline to Week12]
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.
- Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values in Week24 [Baseline to 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.
- Change From Baseline in Body weight [Baseline to Week24]
Change in body weight
- Number of Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events(SAE) [from baseline to Week25]
Safety
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sunshine Lake Pharma Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22011-DM-301