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

Sunshine Lake Pharma Co., Ltd.414 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

414

Conditions

Diabetes

Interventions

Insulin Degludec and Insulin AspartDRUG

administered subcutaneously, once a day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sunshine Lake Pharma Co., Ltd.

Dongguan, Guangdong, China

Outcomes

Primary Outcomes

Change From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time

Time frame: Baseline to Week 24

Secondary Outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12

HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time

Time frame: Baseline to Week12

Percentage of Participant Who Achieved HbA1c<7% and ≤6.5%

the ratio of participant Who Achieved HbA1c\<7% and ≤6.5%

Time frame: 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

Time frame: Baseline to Week24

Change From Baseline in Fasting Plasma Glucose(FPG)

the plasma glucose concentration on an empty stomach

Time frame: Baseline to Week12

Change From Baseline in Fasting Plasma Glucose(FPG) in Week24

the plasma glucose concentration on an empty stomach

Time frame: 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.

Time frame: Baseline to Week12

Data from ClinicalTrials.gov

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