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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Ryzodeg®

• Study Type: Observational
• Enrollment (Actual): 887

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230012
      • NIS-The Second People's Hospital of Hefei
  • Beijing
    • Beijing, Beijing, China, 100005
      • NIS-Beijing Hospital
    • Beijing, Beijing, China, 100050
      • NIS-Beijing Friendship Hospital, Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400320
      • NIS-People's Hospital of Chongqing Banan District
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • NIS-Gansu Provincial People's Hospital
  • Guangdong
    • Jiangmen, Guangdong, China, 529020
      • NIS-The people's hospital of JiangMen
    • Shantou, Guangdong, China, 515041
      • NIS-2nd Affiliated Hospital of Shantou University Medical
    • Shenzhen, Guangdong, China, 518172
      • NIS-Shenzhen Longgang District People's Hospital
    • Yangjiang, Guangdong, China, 529500
      • NIS-Yangjiang People's Hospital
  • Guangxi
    • Yulin, Guangxi, China, 37000
      • NIS-The First People's Hospital of Yulin City
  • Hainan
    • Haikou, Hainan, China, 570203
      • NIS-Hainan Provincial Hospital of TCM
  • Hebei
    • Cangzhou, Hebei, China, 061013
      • NIS-Cangzhou Hosp of Integrated Traditional Chinese Medicine
    • Handan, Hebei, China, 056002
      • NIS-The First Hospital of Handan
    • Qinhuangdao, Hebei, China, 066000
      • NIS-The First Hospital of Qinhuangdao
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150036
      • NIS-Heilongjiang Provincial Hospital
  • Henan
    • Zhengzhou, Henan, China, 450014
      • NIS-Zhengzhou University - The Second Affiliated Hospital
  • Hubei
    • Shiyan, Hubei, China, 442099
      • NIS-Shiyan City People's Hospital
    • Wuhan, Hubei, China, 430000
      • NIS-Puai Hospital of Wuhan
  • Hunan
    • Changsha, Hunan, China, 410013
      • NIS-The Third Xiangya Hospital of Central South University
  • Inner Mongolia Autonomous Region
    • Chifeng, Inner Mongolia Autonomous Region, China, 024099
      • NIS-The Sceond Hospital of Chifeng
    • Tongliao, Inner Mongolia Autonomous Region, China, 028000
      • NIS-Inner Mongolia University for Nationalities - Affiliated
  • Jiangsu
    • Changshu, Jiangsu, China, 215501
      • NIS-Changshu Second People's Hospital
    • Huai'an, Jiangsu, China, 223300
      • NIS-Huai'an First People's Hospital
    • Nanjing, Jiangsu, China, 211199
      • NIS-Nanjing Jiangning Hospital
    • Nanjing, Jiangsu, China, 320100
      • NIS-Jiangsu Province Officeial Hospital
    • Nantong, Jiangsu, China, 226006
      • NIS-Nantong University - Affiliated Hospital
    • Yixing, Jiangsu, China, 214200
      • NIS-Yixing City People's Hospital
  • Jilin
    • Jilin, Jilin, China, 132013
      • NIS-Affiliated Hospital of Jilin Medical College
    • Songyuan, Jilin, China, 138000
      • NIS-Songyuan Jilin Oilfield Hospital
  • Liaoning
    • Dalian, Liaoning, China, 116033
      • NIS-The Third People's Hospital of Dalian
    • Huludao, Liaoning, China, 125000
      • NIS-Huludao Central Hospital
    • Jinzhou, Liaoning, China, 121012
      • NIS-Third Affiliated Hospital of Jinzhou Medical University
    • Shenyang, Liaoning, China, 110032
      • NIS-The Fourth Hospital of China Medical University
  • Ningxia Hui Autonomous Region
    • Yinchuan, Ningxia Hui Autonomous Region, China, 750021
      • NIS-The People's Hospital of Ningxia Hui Autonomous Region
  • Qinghai
    • Xining, Qinghai, China, 810099
      • NIS- Qinghai Red Cross Hospital
  • Shaanxi
    • Hanzhong, Shaanxi, China, 723000
      • NIS-Hanzhong Central Hospital
    • Taiyuan, Shaanxi, China, 030032
      • NIS-Shanxi Bethune Hospital
    • Xi'an, Shaanxi, China, 710018
      • NIS-Xi'an No.3 Hospital
  • Shandong
    • Weifang, Shandong, China, 261035
      • NIS-Weifang Medical University - Affiliated Hospital
    • Yantai, Shandong, China, 256699
      • NIS-Binzhou Medical University-Yantai Affiliated Hospital
    • Zhibo, Shandong, China, 255036
      • NIS-Central hospital of zibo
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • NIS-Shanghai Shidong Hospital
    • Shanghai, Shanghai, China, 201203
      • NIS-Shanghai Shuguang Hospital
  • Sichuan
    • Nanchong, Sichuan, China, 637000
      • NIS-Affiliated Hospital of North Sichuan Medical College
  • Tianjin
    • Tianjin, Tianjin, China, 300070
      • NIS-Metabolic Diseases Hosp&Tianjin Institute of Endocrinolo
    • Tianjin, Tianjin, China, 300190
      • NIS-Tianjin First Center Hospital
  • Yunnan
    • Mang, Yunnan, China, 678400
      • NIS-De Hong Zhou People's Hospital
    • Qujing, Yunnan, China, 655099
      • NIS-The First People's Hospital of Qujing
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • NIS-Zhejiang Provincial People's Hospital
    • Shaoxing, Zhejiang, China, 312030
      • NIS-Shaoxing Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Real-world adult population with type 2 diabetes in China.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Real-world adult population of Chinese patients with T2DM; Ryzodec as per local clinical practise	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycosylated Haemoglobin (HbA1c)	Percentage point	From baseline (week 0) to end of study (week 20 to 32)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c less than 7 percent (Yes/No)	Percentage of patients	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)	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).
Change in Fasting Plasma Glucose (FPG)	mmol/L	From baseline (week 0) to end of study (week 20 to 32)
Change in insulin dose (total, basal, prandial)	units/day	From baseline (week 0) to end of study (week 20 to 32)
Change in body weight	Kg	From baseline (week 0) to end of study (week 20 to 32)
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)
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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin degludec, insulin aspart drug combination
• Other Study ID Numbers: NN5401-4623; U1111-1238-6960 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No