China Research of IDEgAsp Treatment in Real-world Clinical practicE (CREATE)

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221580
• Other study ID #: NN5401-4623
• Secondary ID: U1111-1238-6960
• Status: Completed
• Start date: March 18, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: June 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 887
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Ryzodeg®
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

Locations

Country	Name	City	State
China	NIS-Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	NIS-Beijing Hospital	Beijing	Beijing
China	NIS-Cangzhou Hosp of Integrated Traditional Chinese Medicine	Cangzhou	Hebei
China	NIS-The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	NIS-Changshu Second People's Hospital	Changshu	Jiangsu
China	NIS-The Sceond Hospital of Chifeng	Chifeng	Inner Mongolia Autonomous Region
China	NIS-People's Hospital of Chongqing Banan District	Chongqing	Chongqing
China	NIS-The Third People's Hospital of Dalian	Dalian	Liaoning
China	NIS-Hainan Provincial Hospital of TCM	Haikou	Hainan
China	NIS-The First Hospital of Handan	Handan	Hebei
China	NIS-Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	NIS-Hanzhong Central Hospital	Hanzhong	Shaanxi
China	NIS-Heilongjiang Provincial Hospital	Harbin	Heilongjiang
China	NIS-The Second People's Hospital of Hefei	Hefei	Anhui
China	NIS-Huai'an First People's Hospital	Huai'an	Jiangsu
China	NIS-Huludao Central Hospital	Huludao	Liaoning
China	NIS-The people's hospital of JiangMen	Jiangmen	Guangdong
China	NIS-Affiliated Hospital of Jilin Medical College	Jilin	Jilin
China	NIS-Third Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning
China	NIS-Gansu Provincial People's Hospital	Lanzhou	Gansu
China	NIS-De Hong Zhou People's Hospital	Mang	Yunnan
China	NIS-Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan
China	NIS-Jiangsu Province Officeial Hospital	Nanjing	Jiangsu
China	NIS-Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	NIS-Nantong University - Affiliated Hospital	Nantong	Jiangsu
China	NIS-The First Hospital of Qinhuangdao	Qinhuangdao	Hebei
China	NIS-The First People's Hospital of Qujing	Qujing	Yunnan
China	NIS-Shanghai Shidong Hospital	Shanghai	Shanghai
China	NIS-Shanghai Shuguang Hospital	Shanghai	Shanghai
China	NIS-2nd Affiliated Hospital of Shantou University Medical	Shantou	Guangdong
China	NIS-Shaoxing Central Hospital	Shaoxing	Zhejiang
China	NIS-The Fourth Hospital of China Medical University	Shenyang	Liaoning
China	NIS-Shenzhen Longgang District People's Hospital	Shenzhen	Guangdong
China	NIS-Shiyan City People's Hospital	Shiyan	Hubei
China	NIS-Songyuan Jilin Oilfield Hospital	Songyuan	Jilin
China	NIS-Shanxi Bethune Hospital	Taiyuan	Shaanxi
China	NIS-Metabolic Diseases Hosp&Tianjin Institute of Endocrinolo	Tianjin	Tianjin
China	NIS-Tianjin First Center Hospital	Tianjin	Tianjin
China	NIS-Inner Mongolia University for Nationalities - Affiliated	Tongliao	Inner Mongolia Autonomous Region
China	NIS-Weifang Medical University - Affiliated Hospital	Weifang	Shandong
China	NIS-Puai Hospital of Wuhan	Wuhan	Hubei
China	NIS-Xi'an No.3 Hospital	Xi'an	Shaanxi
China	NIS- Qinghai Red Cross Hospital	Xining	Qinghai
China	NIS-Yangjiang People's Hospital	Yangjiang	Guangdong
China	NIS-Binzhou Medical University-Yantai Affiliated Hospital	Yantai	Shandong
China	NIS-The People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia Hui Autonomous Region
China	NIS-Yixing City People's Hospital	Yixing	Jiangsu
China	NIS-The First People's Hospital of Yulin City	Yulin	Guangxi
China	NIS-Zhengzhou University - The Second Affiliated Hospital	Zhengzhou	Henan
China	NIS-Central hospital of zibo	Zhibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin (HbA1c)	Percentage point	From baseline (week 0) to end of study (week 20 to 32)
Secondary	HbA1c less than 7 percent (Yes/No)	Percentage of patients	At the end of study (week 20 to 32)
Secondary	HbA1c less than 7 percent without any hypoglycaemic episodes during 4 weeks prior to end of study (Yes/No)	Percentage of patients	At the end of study (week 20 to 32) Hypoglycaemic episodes occurring within 4 weeks prior to end of study (week 20 to 32).
Secondary	Change in Fasting Plasma Glucose (FPG)	mmol/L	From baseline (week 0) to end of study (week 20 to 32)
Secondary	Change in insulin dose (total, basal, prandial)	units/day	From baseline (week 0) to end of study (week 20 to 32)
Secondary	Change in body weight	Kg	From baseline (week 0) to end of study (week 20 to 32)
Secondary	Patient preference compared to previous treatment	Percentage of patients who prefer to continue treatment with Ryzodeg® over previous treatment. Assessed by questionnaire	At baseline and end of study (week 20 to 32)
Secondary	Treatment satisfaction questionnaire (Diabetes Treatment Satisfaction Questionnaire (DTSQ))	Score based on items 1, 4, 5, 6, 7 and 8. Range 0-36, where higher score means greater satisfaction (better outcome)	At baseline and end of study (week 20 to 32)