A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in China

Diabetes Mellitus, Type 2 Clinical Trial

— CN-TREAT  

Official title:

The Effect of Tresiba® (Insulin Degludec) in Type 2 Diabetes Patients in Real World Clinical Practice in China - Noninterventional, Retrospective Chart Review Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227431
• Other study ID #: NN1250-4442
• Secondary ID: U1111-1208-5180
• Status: Completed
• Start date: January 17, 2020
• Est. completion date: July 17, 2021

Study information

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

Clinical Trial Summary

The purpose of the study is to collect information on how Tresiba® works in patients with type 2 diabetes in China. The study will be based on data already recorded in participants' medical records and no new tests or procedures are required as part of the study. This study does not affect participants' current diabetes treatment. The study will look at data recorded in participants' medical records for approximately the last year. After signing the informed consent form, no further activities will be required from the participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 938
• Est. completion date: July 17, 2021
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent Form (ICF) obtained before any study-related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.

• Male or female, aged at least 18 years at the time of signing the ICF.

• Diagnosed with T2D.

• Treated with any OAD(s) or basal insulin ± OAD(s), with or without prandial insulin for at least 20 weeks prior to treatment initiation with Tresiba®.

• The decision to initiate treatment with commercially available Tresiba® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

• Treated with Tresiba® (with or without OADs, with or without prandial insulin) for at least 20 weeks and have at least one documented medical visit with HbA1c measurement in the first 20 weeks (plus/minus 8 weeks) after Tresiba® initiation. The patient may or may not be treated with Tresiba® at the time of patient selection to this study.

• Minimum available data: age, weight, and sex at the time of Tresiba® initiation, HbA1c (most recent value within 12 weeks prior to Tresiba® initiation and a value in the first 20 weeks [plus/minus 8 weeks] after Tresiba® treatment), and duration and type of insulin treatment (for insulin treated patients).

Exclusion Criteria:

• Previous participation in this study. Participation is defined as having signed the ICF.

• Participation (defined as randomisation) in a diabetes clinical trial of an approved or non-approved investigational medicinal product within 20 weeks prior to the treatment initiation with Tresiba® or during the first 28 weeks of treatment with Tresiba®.

• Tresiba® not used in accordance with the local label.

• Patients treated with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving Tresiba® (short-term [equal to or less than 14 days] treatment with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving Tresiba® is allowed).

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Insulin degludec
Participants have been treated with Tresiba® (insulin degludec) for at least 20 weeks before entering the study. The study will be based on data already recorded in participants' medical records for approximately the last year and no new tests or procedures are required as part of the study.

Locations

Country	Name	City	State
China	NIS-Cangzhou Central Hospital	Cangzhou	Hebei
China	NIS-No.2 Hospital Affiliated to Jilin University	Changchun	Jilin
China	NIS-The 1st Affi. Hosp. of Changchun Univer. of Chinese Medi	Changchun	Jilin
China	NIS-Heping Hospital Affiliated to Changzhi Medical College	Changzhi	Shaanxi
China	NIS-Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	NIS-No.9 People's Hospital of Chongqing	Chongqing	Chongqing
China	NIS-The Third Affiliated Hospital of Chongqing Medical Univ.	Chongqing	Chongqing
China	NIS-Dali First People's Hospital	Dali	Yunnan
China	NIS-Dingzhou People's Hospital	Dingzhou	Hebei
China	NIS-The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	NIS-Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	NIS-Hainan Provincial Hospital of TCM	Haikou	Hainan
China	NIS-Haerbin 1st Hospital	Harbin	Heilongjiang
China	NIS-Heilongjiang Provincial Hospital	Harbin	Heilongjiang
China	NIS-The Second Affiliated Hospital of Harbin Medical Univ.	Harbin	Heilongjiang
China	NIS-The Second Hospital of Anhui Medical Hospital	Hefei	Anhui
China	NIS-Huizhou Third People's Hospital	Huizhou	Guangdong
China	NIS-The No.2 Hospital affiliated to Guizhou Medical college	Kaili
China	NIS-The Second Affiliated Hospital of Kunming Medical Univ.	Kunming	Yunnan
China	NIS-Kunshan 1st People's Hospital	Kunshan	Jiangsu
China	NIS-CNPC Central Hospital	Langfang	Hebei
China	NIS-Langfang people's Hospital	Langfang	Hebei
China	NIS-People's Hospital of Gansu Province	Lanzhou	Gansu
China	NIS-People's Hospital of Linxia, Gansu	Linxia	Gansu
China	NIS-Nanjing Jiangbei Hospital	Nanjing	Jiangsu
China	NIS-Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	NIS-The Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu
China	NIS-Zhong Da Hospital Southeast University	Nanjing	Jiangsu
China	NIS-Ningbo First Hospital	Ningbo	Zhejiang
China	NIS-Qingyuan People's Hospital	Qingyuan	Guangdong
China	NIS-People's Hospital of Liaoning Province	Shenyang	Liaoning
China	NIS-Shenyang Central Hospital	Shenyang	Liaoning
China	NIS-The 4th Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	NIS-The Affiliated Hospital of Liaoning TCM University	Shenyang	Liaoning
China	NIS-General Hospital of Shenzhen University	Shenzhen	Guangdong
China	NIS-Shenzhen Futian District People's Hospital	Shenzhen	Guangdong
China	NIS-The University of Hong Kong-Shenzhen Hospital	Shenzhen	Guangdong
China	NIS-No.1 Hospital affiliated to Shihezi Medical College	Shihezi	Xinjiang
China	NIS-The 3rd Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	NIS-General Hospital of Shiyan Dongfeng Group	Shiyan	Hubei
China	NIS-The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	NIS-Zhangjiagang Hospital of Traditional Chinese Medicine	Suzhou	Jiangsu
China	NIS-Second Hospital of Shanxi Medical University	Taiyuan	Shaanxi
China	NIS-Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	NIS-The 2nd Affiliated Hospital of Xinjiang Medical Univer.	Urumqi	Xinjiang
China	NIS-The 5th Affiliated Hospital of Xinjiang Medical Univ.	Urumqi	Xinjiang
China	NIS-The First Affiliated Hospital of Xinjiang Medical Univ.	Urumqi	Xinjiang
China	NIS-Xinjiang Traditional Chinese Medicine Hospital	Urumqi	Xinjiang
China	NIS-Weifang People's Hospital	Weifang	Shandong
China	NIS-Wuxi 2nd People's Hospital	Wuxi	Jiangsu
China	NIS-Affiliated Hospital of Shanxi TCM Colleage	Xianyang	Shaanxi
China	NIS- Qinghai Red Cross Hospital	Xining	Qinghai
China	NIS-People's Hospital of Qinghai Province	Xining
China	NIS-Affiliated Hospital of Shanxi Yanan Medical Colleage	Yan'an	Shaanxi
China	NIS-People's Hospital of Henan Province	Zhengzhou	Hainan
China	NIS-The First Affiliated Hospital, Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang W, Chang X, Lehrskov LL, Li L, Nordentoft M, Quan J, Sha Y, Zhong X, Yang C, Zhu D. Insulin Degludec in People with Type 2 Diabetes in China: A Non-interventional, Retrospective Chart Review Study (CN-TREAT). Diabetes Ther. 2024 Mar;15(3):725-739. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycosylated haemoglobin (HbA1c)	Percent point	Week 0, week 20
Secondary	Change in laboratory-measured fasting plasma glucose (FPG)	mmol/L	From baseline (week 0) to end of study (week 20)
Secondary	Change in self-measured fasting plasma glucose (SMPG)	mmol/L	From baseline (week 0) to end of study (week 20)
Secondary	Change in daily insulin doses (total, basal, prandial)	Units/day	From baseline (week 0) to end of study (week 20)
Secondary	Change in rates of hypoglycaemic episodes (number of episodes/patient years) (overall, nonsevere, severe, nocturnal) before and after add on of/switch to Tresiba®	Count. All recorded events will be captured in the 20 weeks prior to treatment initiation with Tresiba (week 0) and 20 weeks after treatments initiation with Tresiba (week 20)	From baseline (week 0) to end of study (week 20)
Secondary	Patient having at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after add-on of/switch to Tresiba® (Yes/no)	Count	From baseline (week 0) to end of study (week 20)
Secondary	Change in number of concomitant non-insulin anti-diabetic drugs before and after add-on/switch to Tresiba®	Count. All recorded recorded concomitant non-insulin antidiabetic drugs will be captured in the 20 weeks prior to treatment initiation with Tresiba (week 0) and 20 weeks after treatments initiation with Tresiba (week 20)	From baseline (week 0) to end of study (week 20)
Secondary	Reason(s) for starting Tresiba®, at time of switch/add-on, if available	Free text listing	At baseline (week 20)