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CompletedNCT05221580CREATEUpdated Jun 14, 2024

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

An observational study in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 50 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
887
Ages
18 Years and older
Sex
All
01

Study 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

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Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.

This study's enrollment of 887 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 101 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
887 participants (actual)
Patient registry
No

Groups and cohorts

  • Real-world adult population of Chinese patients with T2DM

    Ryzodec as per local clinical practise

    Drug: Ryzodeg®

Interventions

  • DrugRyzodeg®

    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

06

What researchers measure

Primary outcomes

  1. Change in Glycosylated Haemoglobin (HbA1c)

    Percentage point

    Time frame: From baseline (week 0) to end of study (week 20 to 32)

Secondary outcomes

  1. HbA1c less than 7 percent (Yes/No)

    Percentage of patients

    Time frame: At the end of study (week 20 to 32)

  2. HbA1c less than 7 percent without any hypoglycaemic episodes during 4 weeks prior to end of study (Yes/No)

    Percentage of patients

    Time frame: At the end of study (week 20 to 32) Hypoglycaemic episodes occurring within 4 weeks prior to end of study (week 20 to 32).

  3. Change in Fasting Plasma Glucose (FPG)

    mmol/L

    Time frame: From baseline (week 0) to end of study (week 20 to 32)

  4. Change in insulin dose (total, basal, prandial)

    units/day

    Time frame: From baseline (week 0) to end of study (week 20 to 32)

  5. Change in body weight

    Kg

    Time frame: From baseline (week 0) to end of study (week 20 to 32)

  6. Patient preference compared to previous treatment

    Percentage of patients who prefer to continue treatment with Ryzodeg® over previous treatment. Assessed by questionnaire

    Time frame: At baseline and end of study (week 20 to 32)

  7. 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)

    Time frame: At baseline and end of study (week 20 to 32)

07

Study locations

50 sites
  • NIS-The Second People's Hospital of Hefei
    Hefei, Anhui 230012, China
  • NIS-Beijing Hospital
    Beijing, Beijing 100005, China
  • NIS-Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing 100050, China
  • NIS-People's Hospital of Chongqing Banan District
    Chongqing, Chongqing 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 Autonomous Region 024099, China
  • NIS-Inner Mongolia University for Nationalities - Affiliated
    Tongliao, Inner Mongolia Autonomous Region 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 Hui Autonomous Region 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 200433, China
  • NIS-Shanghai Shuguang Hospital
    Shanghai, Shanghai 201203, China
  • NIS-Affiliated Hospital of North Sichuan Medical College
    Nanchong, Sichuan 637000, China
  • NIS-Metabolic Diseases Hosp&Tianjin Institute of Endocrinolo
    Tianjin, Tianjin 300070, China
  • NIS-Tianjin First Center Hospital
    Tianjin, Tianjin 300190, China
  • NIS-De Hong Zhou People's Hospital
    Mang, 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
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05221580
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Feb 3, 2022
Start date
Mar 18, 2022
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023
Last update
Jun 14, 2024

Study contacts

Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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