Clinical trial NCT04227431: A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in China
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 938
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes Mellitus, Type 2 (T2D) patients, who had Tresiba® added to their previous Oral Anti-diabetic drugs (OADs) or were switched to Tresiba® treatment from any previous basal insulin based on the clinical judgement of the treating physician and were treated with Tresiba® for at least 20 weeks in routine clinical practice in China.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in glycosylated haemoglobin (HbA1c)
timeFrame: Week 0, week 20
Secondary outcomes:
measure: Change in laboratory-measured fasting plasma glucose (FPG)
timeFrame: From baseline (week 0) to end of study (week 20)
measure: Change in self-measured fasting plasma glucose (SMPG)
timeFrame: From baseline (week 0) to end of study (week 20)
measure: Change in daily insulin doses (total, basal, prandial)
timeFrame: From baseline (week 0) to end of study (week 20)
measure: Change in rates of hypoglycaemic episodes (number of episodes/patient years) (overall, nonsevere, severe, nocturnal) before and after add on of/switch to Tresiba®
timeFrame: From baseline (week 0) to end of study (week 20)
measure: Patient having at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after add-on of/switch to Tresiba® (Yes/no)
timeFrame: From baseline (week 0) to end of study (week 20)
measure: Change in number of concomitant non-insulin anti-diabetic drugs before and after add-on/switch to Tresiba®
timeFrame: From baseline (week 0) to end of study (week 20)
measure: Reason(s) for starting Tresiba®, at time of switch/add-on, if available
timeFrame: At baseline (week 20)
Other outcomes:
Locations:
city: Hefei
country: China
facility: NIS-The Second Hospital of Anhui Medical Hospital
state: Anhui
city: Chongqing
country: China
facility: NIS-No.9 People's Hospital of Chongqing
state: Chongqing
city: Chongqing
country: China
facility: NIS-The Third Affiliated Hospital of Chongqing Medical Univ.
state: Chongqing
city: Lanzhou
country: China
facility: NIS-People's Hospital of Gansu Province
state: Gansu
city: Linxia
country: China
facility: NIS-People's Hospital of Linxia, Gansu
state: Gansu
city: Guangzhou
country: China
facility: NIS-Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: NIS-The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Huizhou
country: China
facility: NIS-Huizhou Third People's Hospital
state: Guangdong
city: Qingyuan
country: China
facility: NIS-Qingyuan People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: NIS-Shenzhen Futian District People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: NIS-The University of Hong Kong-Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: NIS-General Hospital of Shenzhen University
state: Guangdong
city: Haikou
country: China
facility: NIS-Hainan Provincial Hospital of TCM
state: Hainan
city: Zhengzhou
country: China
facility: NIS-People's Hospital of Henan Province
state: Hainan
city: Cangzhou
country: China
facility: NIS-Cangzhou Central Hospital
state: Hebei
city: Dingzhou
country: China
facility: NIS-Dingzhou People's Hospital
state: Hebei
city: Langfang
country: China
facility: NIS-CNPC Central Hospital
state: Hebei
city: Langfang
country: China
facility: NIS-Langfang people's Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: NIS-The 3rd Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: NIS-Haerbin 1st Hospital
state: Heilongjiang
city: Harbin
country: China
facility: NIS-The Second Affiliated Hospital of Harbin Medical Univ.
state: Heilongjiang
city: Harbin
country: China
facility: NIS-Heilongjiang Provincial Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: NIS-The First Affiliated Hospital, Zhengzhou University
state: Henan
city: Shiyan
country: China
facility: NIS-General Hospital of Shiyan Dongfeng Group
state: Hubei
city: Changzhou
country: China
facility: NIS-Changzhou No.2 People's Hospital
state: Jiangsu
city: Kunshan
country: China
facility: NIS-Kunshan 1st People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: NIS-Nanjing Jiangbei Hospital
state: Jiangsu
city: Nanjing
country: China
facility: NIS-The Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
city: Nanjing
country: China
facility: NIS-Zhong Da Hospital Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: NIS-Nanjing Jiangning Hospital
state: Jiangsu
city: Suzhou
country: China
facility: NIS-The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: NIS-Zhangjiagang Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Wuxi
country: China
facility: NIS-Wuxi 2nd People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: NIS-No.2 Hospital Affiliated to Jilin University
state: Jilin
city: Changchun
country: China
facility: NIS-The 1st Affi. Hosp. of Changchun Univer. of Chinese Medi
state: Jilin
city: Shenyang
country: China
facility: NIS-People's Hospital of Liaoning Province
state: Liaoning
city: Shenyang
country: China
facility: NIS-Shenyang Central Hospital
state: Liaoning
city: Shenyang
country: China
facility: NIS-The Affiliated Hospital of Liaoning TCM University
state: Liaoning
city: Shenyang
country: China
facility: NIS-The 4th Affiliated Hospital of China Medical University
state: Liaoning
city: Xining
country: China
facility: NIS- Qinghai Red Cross Hospital
state: Qinghai
city: Changzhi
country: China
facility: NIS-Heping Hospital Affiliated to Changzhi Medical College
state: Shaanxi
city: Taiyuan
country: China
facility: NIS-Second Hospital of Shanxi Medical University
state: Shaanxi
city: Xianyang
country: China
facility: NIS-Affiliated Hospital of Shanxi TCM Colleage
state: Shaanxi
city: Yan'an
country: China
facility: NIS-Affiliated Hospital of Shanxi Yanan Medical Colleage
state: Shaanxi
city: Weifang
country: China
facility: NIS-Weifang People's Hospital
state: Shandong
city: Taiyuan
country: China
facility: NIS-Shanxi Provincial People's Hospital
state: Shanxi
city: Shihezi
country: China
facility: NIS-No.1 Hospital affiliated to Shihezi Medical College
state: Xinjiang
city: Urumqi
country: China
facility: NIS-Xinjiang Traditional Chinese Medicine Hospital
state: Xinjiang
city: Urumqi
country: China
facility: NIS-The 5th Affiliated Hospital of Xinjiang Medical Univ.
state: Xinjiang
city: Urumqi
country: China
facility: NIS-The 2nd Affiliated Hospital of Xinjiang Medical Univer.
state: Xinjiang
city: Urumqi
country: China
facility: NIS-The First Affiliated Hospital of Xinjiang Medical Univ.
state: Xinjiang
city: Dali
country: China
facility: NIS-Dali First People's Hospital
state: Yunnan
city: Kunming
country: China
facility: NIS-The Second Affiliated Hospital of Kunming Medical Univ.
state: Yunnan
city: Ningbo
country: China
facility: NIS-Ningbo First Hospital
state: Zhejiang
city: Kaili
country: China
facility: NIS-The No.2 Hospital affiliated to Guizhou Medical college
city: Xining
country: China
facility: NIS-People's Hospital of Qinghai Province
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1007/s13300-024-01533-6. Epub 2024 Mar 5.