Clinical trial NCT05221580: China Research of IDEgAsp Treatment in Real-world Clinical practicE (CREATE)
Official title: A Prospective Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-02-03
Enrollment: 887
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Real-world adult population with type 2 diabetes in China.

Brief summary: The purpose of this study is to collect information on how Ryzodeg® works in real-world patients.

Participants will get Ryzodeg® as prescribed to by their doctor. The study will last for about 5-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment


Eligibility criteria: Inclusion Criteria:

1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. The decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on the approved Ryzodeg® label in China and independently from the decision to include the patient in this study.
3. Male or female, age above or equal to 18 years at the time of signing informed consent.
4. Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 20 weeks prior to Treatment Initiation Visit (Visit 1).
5. Available and documented Glycosylated haemoglobin (HbA1c) value below or equal to 12 weeks prior to Informed Consent and Treatment Initiation Visit (Visit 1).

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Treatment with any investigational drug within 30 days prior to enrolment into the study.
3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
4. Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Ryzodeg® label in China.

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of study (week 20 to 32)
Secondary outcomes:
measure: HbA1c less than 7 percent (Yes/No)
timeFrame: At the end of study (week 20 to 32)
measure: HbA1c less than 7 percent without any hypoglycaemic episodes during 4 weeks prior to end of study (Yes/No)
timeFrame: At the end of study (week 20 to 32) Hypoglycaemic episodes occurring within 4 weeks prior to end of study (week 20 to 32).
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: From baseline (week 0) to end of study (week 20 to 32)
measure: Change in insulin dose (total, basal, prandial)
timeFrame: From baseline (week 0) to end of study (week 20 to 32)
measure: Change in body weight
timeFrame: From baseline (week 0) to end of study (week 20 to 32)
measure: Patient preference compared to previous treatment
timeFrame: At baseline and end of study (week 20 to 32)
measure: Treatment satisfaction questionnaire (Diabetes Treatment Satisfaction Questionnaire (DTSQ))
timeFrame: At baseline and end of study (week 20 to 32)
Other outcomes:
Locations:
city: Hefei
country: China
facility: NIS-The Second People's Hospital of Hefei
state: Anhui
city: Beijing
country: China
facility: NIS-Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: NIS-Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: NIS-People's Hospital of Chongqing Banan District
state: Chongqing
city: Lanzhou
country: China
facility: NIS-Gansu Provincial People's Hospital
state: Gansu
city: Jiangmen
country: China
facility: NIS-The people's hospital of JiangMen
state: Guangdong
city: Shantou
country: China
facility: NIS-2nd Affiliated Hospital of Shantou University Medical
state: Guangdong
city: Shenzhen
country: China
facility: NIS-Shenzhen Longgang District People's Hospital
state: Guangdong
city: Yangjiang
country: China
facility: NIS-Yangjiang People's Hospital
state: Guangdong
city: Yulin
country: China
facility: NIS-The First People's Hospital of Yulin City
state: Guangxi
city: Haikou
country: China
facility: NIS-Hainan Provincial Hospital of TCM
state: Hainan
city: Cangzhou
country: China
facility: NIS-Cangzhou Hosp of Integrated Traditional Chinese Medicine
state: Hebei
city: Handan
country: China
facility: NIS-The First Hospital of Handan
state: Hebei
city: Qinhuangdao
country: China
facility: NIS-The First Hospital of Qinhuangdao
state: Hebei
city: Harbin
country: China
facility: NIS-Heilongjiang Provincial Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: NIS-Zhengzhou University - The Second Affiliated Hospital
state: Henan
city: Shiyan
country: China
facility: NIS-Shiyan City People's Hospital
state: Hubei
city: Wuhan
country: China
facility: NIS-Puai Hospital of Wuhan
state: Hubei
city: Changsha
country: China
facility: NIS-The Third Xiangya Hospital of Central South University
state: Hunan
city: Chifeng
country: China
facility: NIS-The Sceond Hospital of Chifeng
state: Inner Mongolia Autonomous Region
city: Tongliao
country: China
facility: NIS-Inner Mongolia University for Nationalities - Affiliated
state: Inner Mongolia Autonomous Region
city: Changshu
country: China
facility: NIS-Changshu Second People's Hospital
state: Jiangsu
city: Huai'an
country: China
facility: NIS-Huai'an First People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: NIS-Nanjing Jiangning Hospital
state: Jiangsu
city: Nanjing
country: China
facility: NIS-Jiangsu Province Officeial Hospital
state: Jiangsu
city: Nantong
country: China
facility: NIS-Nantong University - Affiliated Hospital
state: Jiangsu
city: Yixing
country: China
facility: NIS-Yixing City People's Hospital
state: Jiangsu
city: Jilin
country: China
facility: NIS-Affiliated Hospital of Jilin Medical College
state: Jilin
city: Songyuan
country: China
facility: NIS-Songyuan Jilin Oilfield Hospital
state: Jilin
city: Dalian
country: China
facility: NIS-The Third People's Hospital of Dalian
state: Liaoning
city: Huludao
country: China
facility: NIS-Huludao Central Hospital
state: Liaoning
city: Jinzhou
country: China
facility: NIS-Third Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: NIS-The Fourth Hospital of China Medical University
state: Liaoning
city: Yinchuan
country: China
facility: NIS-The People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia Hui Autonomous Region
city: Xining
country: China
facility: NIS- Qinghai Red Cross Hospital
state: Qinghai
city: Hanzhong
country: China
facility: NIS-Hanzhong Central Hospital
state: Shaanxi
city: Taiyuan
country: China
facility: NIS-Shanxi Bethune Hospital
state: Shaanxi
city: Xi'an
country: China
facility: NIS-Xi'an No.3 Hospital
state: Shaanxi
city: Weifang
country: China
facility: NIS-Weifang Medical University - Affiliated Hospital
state: Shandong
city: Yantai
country: China
facility: NIS-Binzhou Medical University-Yantai Affiliated Hospital
state: Shandong
city: Zhibo
country: China
facility: NIS-Central hospital of zibo
state: Shandong
city: Shanghai
country: China
facility: NIS-Shanghai Shidong Hospital
state: Shanghai
city: Shanghai
country: China
facility: NIS-Shanghai Shuguang Hospital
state: Shanghai
city: Nanchong
country: China
facility: NIS-Affiliated Hospital of North Sichuan Medical College
state: Sichuan
city: Tianjin
country: China
facility: NIS-Metabolic Diseases Hosp&Tianjin Institute of Endocrinolo
state: Tianjin
city: Tianjin
country: China
facility: NIS-Tianjin First Center Hospital
state: Tianjin
city: Mang
country: China
facility: NIS-De Hong Zhou People's Hospital
state: Yunnan
city: Qujing
country: China
facility: NIS-The First People's Hospital of Qujing
state: Yunnan
city: Hangzhou
country: China
facility: NIS-Zhejiang Provincial People's Hospital
state: Zhejiang
city: Shaoxing
country: China
facility: NIS-Shaoxing Central Hospital
state: Zhejiang
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: