Diabetes Mellitus, Type 2CREATENCT05221580
China Research of IDEgAsp Treatment in Real-world Clinical practicE (CREATE)
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 50 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Ryzodeg®
- How many people
- 887 participants
- Where
- 50 sitesChina
- Study dates
- 18 Mar 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Real-world adult population with type 2 diabetes in China.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
China50 sites
NIS-Beijing Hospital
Beijing, Beijing Municipality, 100005
NIS-Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
NIS-Cangzhou Hosp of Integrated Traditional Chinese Medicine
Cangzhou, Hebei, 061013
NIS-The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
NIS-Changshu Second People's Hospital
Changshu, Jiangsu, 215501
NIS-The Sceond Hospital of Chifeng
Chifeng, Inner Mongolia, 024099
NIS-People's Hospital of Chongqing Banan District
Chongqing, Chongqing Municipality, 400320
NIS-The Third People's Hospital of Dalian
Dalian, Liaoning, 116033
NIS-Hainan Provincial Hospital of TCM
Haikou, Hainan, 570203
NIS-The First Hospital of Handan
Handan, Hebei, 056002
NIS-Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
NIS-Hanzhong Central Hospital
Hanzhong, Shaanxi, 723000
NIS-Heilongjiang Provincial Hospital
Harbin, Heilongjiang, 150036
NIS-The Second People's Hospital of Hefei
Hefei, Anhui, 230012
NIS-Huai'an First People's Hospital
Huai'an, Jiangsu, 223300
NIS-Huludao Central Hospital
Huludao, Liaoning, 125000
NIS-The people's hospital of JiangMen
Jiangmen, Guangdong, 529020
NIS-Affiliated Hospital of Jilin Medical College
Jilin City, Jilin, 132013
NIS-Third Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121012
NIS-Gansu Provincial People's Hospital
Lanzhou, Gansu, 730000
NIS-De Hong Zhou People's Hospital
Mang City, Yunnan, 678400
NIS-Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000
NIS-Nanjing Jiangning Hospital
Nanjing, Jiangsu, 211199
NIS-Jiangsu Province Officeial Hospital
Nanjing, Jiangsu, 320100
NIS-Nantong University - Affiliated Hospital
Nantong, Jiangsu, 226006
NIS-The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000
NIS-The First People's Hospital of Qujing
Qujing, Yunnan, 655099
NIS-Shanghai Shidong Hospital
Shanghai, Shanghai Municipality, 200433
NIS-Shanghai Shuguang Hospital
Shanghai, Shanghai Municipality, 201203
NIS-2nd Affiliated Hospital of Shantou University Medical
Shantou, Guangdong, 515041
NIS-Shaoxing Central Hospital
Shaoxing, Zhejiang, 312030
NIS-The Fourth Hospital of China Medical University
Shenyang, Liaoning, 110032
NIS-Shenzhen Longgang District People's Hospital
Shenzhen, Guangdong, 518172
NIS-Shiyan City People's Hospital
Shiyan, Hubei, 442099
NIS-Songyuan Jilin Oilfield Hospital
Songyuan, Jilin, 138000
NIS-Shanxi Bethune Hospital
Taiyuan, Shaanxi, 030032
NIS-Metabolic Diseases Hosp&Tianjin Institute of Endocrinolo
Tianjin, Tianjin Municipality, 300070
NIS-Tianjin First Center Hospital
Tianjin, Tianjin Municipality, 300190
NIS-Inner Mongolia University for Nationalities - Affiliated
Tongliao, Inner Mongolia, 028000
NIS-Weifang Medical University - Affiliated Hospital
Weifang, Shandong, 261035
NIS-Puai Hospital of Wuhan
Wuhan, Hubei, 430000
NIS-Xi'an No.3 Hospital
Xi'an, Shaanxi, 710018
NIS- Qinghai Red Cross Hospital
Xining, Qinghai, 810099
NIS-Yangjiang People's Hospital
Yangjiang, Guangdong, 529500
NIS-Binzhou Medical University-Yantai Affiliated Hospital
Yantai, Shandong, 256699
NIS-The People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750021
NIS-Yixing City People's Hospital
Yixing, Jiangsu, 214200
NIS-The First People's Hospital of Yulin City
Yulin, Guangxi, 37000
NIS-Zhengzhou University - The Second Affiliated Hospital
Zhengzhou, Henan, 450014
NIS-Central hospital of zibo
Zhibo, Shandong, 255036
About this study
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
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
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Ryzodeg®
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ryzodeg®Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Real-world adult population of Chinese patients with T2DM | Ryzodec as per local clinical practise Receives: Drug: Ryzodeg® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Haemoglobin (HbA1c)
Percentage point
Measured: From baseline (week 0) to end of study (week 20 to 32)
Secondary outcomes (7)
HbA1c less than 7 percent (Yes/No)
Percentage of patients
Measured: 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
Measured: 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
Measured: From baseline (week 0) to end of study (week 20 to 32)
Change in insulin dose (total, basal, prandial)
units/day
Measured: From baseline (week 0) to end of study (week 20 to 32)
Change in body weight
Kg
Measured: 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
Measured: 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)
Measured: At baseline and end of study (week 20 to 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start18 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 887 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221580
- Sponsor's protocol ID
- NN5401-4623
- Other IDs
- U1111-1238-6960
- Acronym
- CREATE
- Status last verified
- Jun 2024
- First submitted
- 12 Jan 2022
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05221580
- Acronym / sponsor ID
- CREATE / NN5401-4623
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 887 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real-world adult population of Chinese patients with T2DM | – | Drug: Ryzodeg®Ryzodec as per local clinical practise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Real-world adult population with type 2 diabetes in China.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Real-world adult population of Chinese patients with T2DM |
Primary outcome
Change in Glycosylated Haemoglobin (HbA1c)
Time frame: From baseline (week 0) to end of study (week 20 to 32)
Percentage point
7 secondary outcomes
HbA1c less than 7 percent (Yes/No)
Time frame: 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)
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).
Change in Fasting Plasma Glucose (FPG)
Time frame: From baseline (week 0) to end of study (week 20 to 32)
Change in insulin dose (total, basal, prandial)
Time frame: From baseline (week 0) to end of study (week 20 to 32)
Change in body weight
Time frame: From baseline (week 0) to end of study (week 20 to 32)
Patient preference compared to previous treatment
Time frame: At baseline and end of study (week 20 to 32)
Treatment satisfaction questionnaire (Diabetes Treatment Satisfaction Questionnaire (DTSQ))
Time frame: At baseline and end of study (week 20 to 32)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 50 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycosylated Haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of study (week 20 to 32)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.