China Research of IDEgAsp Treatment in Real-world Clinical practicE (CREATE)
CREATE
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
2 other identifiers
observational
887
1 country
50
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2022
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedStudy Start
First participant enrolled
March 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedJune 14, 2024
June 1, 2024
1 year
January 12, 2022
June 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Glycosylated Haemoglobin (HbA1c)
Percentage point
From baseline (week 0) to end of study (week 20 to 32)
Secondary Outcomes (7)
HbA1c less than 7 percent (Yes/No)
At the end of study (week 20 to 32)
HbA1c less than 7 percent without any hypoglycaemic episodes during 4 weeks prior to end of study (Yes/No)
At the end of study (week 20 to 32) Hypoglycaemic episodes occurring within 4 weeks prior to end of study (week 20 to 32).
Change in Fasting Plasma Glucose (FPG)
From baseline (week 0) to end of study (week 20 to 32)
Change in insulin dose (total, basal, prandial)
From baseline (week 0) to end of study (week 20 to 32)
Change in body weight
From baseline (week 0) to end of study (week 20 to 32)
- +2 more secondary outcomes
Study Arms (1)
Real-world adult population of Chinese patients with T2DM
Ryzodec as per local clinical practise
Interventions
Patients will be treated with commercially available Ryzodeg® in a prefilled device (FlexTouch®) or in a penfill according to the label and routine clinical practice at the discretion of the treating physician
Eligibility Criteria
Real-world adult population with type 2 diabetes in China.
You may qualify if:
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- 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.
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- 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).
- Available and documented Glycosylated haemoglobin (HbA1c) value below or equal to 12 weeks prior to Informed Consent and Treatment Initiation Visit (Visit 1).
You may not qualify if:
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Treatment with any investigational drug within 30 days prior to enrolment into the study.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Ryzodeg® label in China.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (50)
NIS-The Second People's Hospital of Hefei
Hefei, Anhui, 230012, China
NIS-Beijing Hospital
Beijing, Beijing Municipality, 100005, China
NIS-Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
NIS-People's Hospital of Chongqing Banan District
Chongqing, Chongqing Municipality, 400320, China
NIS-Gansu Provincial People's Hospital
Lanzhou, Gansu, 730000, China
NIS-The people's hospital of JiangMen
Jiangmen, Guangdong, 529020, China
NIS-2nd Affiliated Hospital of Shantou University Medical
Shantou, Guangdong, 515041, China
NIS-Shenzhen Longgang District People's Hospital
Shenzhen, Guangdong, 518172, China
NIS-Yangjiang People's Hospital
Yangjiang, Guangdong, 529500, China
NIS-The First People's Hospital of Yulin City
Yulin, Guangxi, 37000, China
NIS-Hainan Provincial Hospital of TCM
Haikou, Hainan, 570203, China
NIS-Cangzhou Hosp of Integrated Traditional Chinese Medicine
Cangzhou, Hebei, 061013, China
NIS-The First Hospital of Handan
Handan, Hebei, 056002, China
NIS-The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000, China
NIS-Heilongjiang Provincial Hospital
Harbin, Heilongjiang, 150036, China
NIS-Zhengzhou University - The Second Affiliated Hospital
Zhengzhou, Henan, 450014, China
NIS-Shiyan City People's Hospital
Shiyan, Hubei, 442099, China
NIS-Puai Hospital of Wuhan
Wuhan, Hubei, 430000, China
NIS-The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
NIS-The Sceond Hospital of Chifeng
Chifeng, Inner Mongolia, 024099, China
NIS-Inner Mongolia University for Nationalities - Affiliated
Tongliao, Inner Mongolia, 028000, China
NIS-Changshu Second People's Hospital
Changshu, Jiangsu, 215501, China
NIS-Huai'an First People's Hospital
Huai'an, Jiangsu, 223300, China
NIS-Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211199, China
NIS-Jiangsu Province Officeial Hospital
Nanjing, Jiangsu, 320100, China
NIS-Nantong University - Affiliated Hospital
Nantong, Jiangsu, 226006, China
NIS-Yixing City People's Hospital
Yixing, Jiangsu, 214200, China
NIS-Affiliated Hospital of Jilin Medical College
Jilin, Jilin, 132013, China
NIS-Songyuan Jilin Oilfield Hospital
Songyuan, Jilin, 138000, China
NIS-The Third People's Hospital of Dalian
Dalian, Liaoning, 116033, China
NIS-Huludao Central Hospital
Huludao, Liaoning, 125000, China
NIS-Third Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121012, China
NIS-The Fourth Hospital of China Medical University
Shenyang, Liaoning, 110032, China
NIS-The People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750021, China
NIS- Qinghai Red Cross Hospital
Xining, Qinghai, 810099, China
NIS-Hanzhong Central Hospital
Hanzhong, Shaanxi, 723000, China
NIS-Shanxi Bethune Hospital
Taiyuan, Shaanxi, 030032, China
NIS-Xi'an No.3 Hospital
Xi'an, Shaanxi, 710018, China
NIS-Weifang Medical University - Affiliated Hospital
Weifang, Shandong, 261035, China
NIS-Binzhou Medical University-Yantai Affiliated Hospital
Yantai, Shandong, 256699, China
NIS-Central hospital of zibo
Zhibo, Shandong, 255036, China
NIS-Shanghai Shidong Hospital
Shanghai, Shanghai Municipality, 200433, China
NIS-Shanghai Shuguang Hospital
Shanghai, Shanghai Municipality, 201203, China
NIS-Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
NIS-Metabolic Diseases Hosp&Tianjin Institute of Endocrinolo
Tianjin, Tianjin Municipality, 300070, China
NIS-Tianjin First Center Hospital
Tianjin, Tianjin Municipality, 300190, China
NIS-De Hong Zhou People's Hospital
Mang City, Yunnan, 678400, China
NIS-The First People's Hospital of Qujing
Qujing, Yunnan, 655099, China
NIS-Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
NIS-Shaoxing Central Hospital
Shaoxing, Zhejiang, 312030, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2022
First Posted
February 3, 2022
Study Start
March 18, 2022
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
June 14, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com