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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1208-5180 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tresiba® | A broad real world type 2 diabetes (T2D) patient population in China, treated with oral anti-diabetic drugs (OAD(s)) or basal insulin prior to treatment initiation with Tresiba® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin degludec | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycosylated haemoglobin (HbA1c) | Percent point | Week 0, week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in laboratory-measured fasting plasma glucose (FPG) | mmol/L | From baseline (week 0) to end of study (week 20) |
| Change in self-measured fasting plasma glucose (SMPG) | mmol/L |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS-The Second Hospital of Anhui Medical Hospital | Hefei | Anhui | 230601 | China | ||
| NIS-No.9 People's Hospital of Chongqing |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38438707 | Result | 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. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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|
| From baseline (week 0) to end of study (week 20) |
| Change in daily insulin doses (total, basal, prandial) | Units/day | From baseline (week 0) to end of study (week 20) |
| 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) |
| 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) |
| 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) |
| Reason(s) for starting Tresiba®, at time of switch/add-on, if available | Free text listing | At baseline (week 20) |
| Chongqing |
| Chongqing Municipality |
| 400700 |
| China |
| NIS-The Third Affiliated Hospital of Chongqing Medical Univ. | Chongqing | Chongqing Municipality | 401120 | China |
| NIS-People's Hospital of Gansu Province | Lanzhou | Gansu | 730000 | China |
| NIS-People's Hospital of Linxia, Gansu | Linxia | Gansu | 731100 | China |
| NIS-Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | 510280 | China |
| NIS-The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
| NIS-Huizhou Third People's Hospital | Huizhou | Guangdong | 516002 | China |
| NIS-Qingyuan People's Hospital | Qingyuan | Guangdong | 511518 | China |
| NIS-Shenzhen Futian District People's Hospital | Shenzhen | Guangdong | 518033 | China |
| NIS-The University of Hong Kong-Shenzhen Hospital | Shenzhen | Guangdong | 518053 | China |
| NIS-General Hospital of Shenzhen University | Shenzhen | Guangdong | 518055 | China |
| NIS-Hainan Provincial Hospital of TCM | Haikou | Hainan | 570203 | China |
| NIS-People's Hospital of Henan Province | Zhengzhou | Hainan | 450003 | China |
| NIS-Cangzhou Central Hospital | Cangzhou | Hebei | 061001 | China |
| NIS-Dingzhou People's Hospital | Dingzhou | Hebei | 073099 | China |
| NIS-CNPC Central Hospital | Langfang | Hebei | 065000 | China |
| NIS-Langfang people's Hospital | Langfang | Hebei | 065000 | China |
| NIS-The 3rd Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050051 | China |
| NIS-Haerbin 1st Hospital | Harbin | Heilongjiang | 150000 | China |
| NIS-The Second Affiliated Hospital of Harbin Medical Univ. | Harbin | Heilongjiang | 150001 | China |
| NIS-Heilongjiang Provincial Hospital | Harbin | Heilongjiang | 150036 | China |
| NIS-The First Affiliated Hospital, Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| NIS-General Hospital of Shiyan Dongfeng Group | Shiyan | Hubei | 442000 | China |
| NIS-Changzhou No.2 People's Hospital | Changzhou | Jiangsu | 213003 | China |
| NIS-Kunshan 1st People's Hospital | Kunshan | Jiangsu | 215300 | China |
| NIS-Nanjing Jiangbei Hospital | Nanjing | Jiangsu | 210000 | China |
| NIS-The Affiliated Drum Tower Hospital of Nanjing University | Nanjing | Jiangsu | 210008 | China |
| NIS-Zhong Da Hospital Southeast University | Nanjing | Jiangsu | 210009 | China |
| NIS-Nanjing Jiangning Hospital | Nanjing | Jiangsu | 211199 | China |
| NIS-The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| NIS-Zhangjiagang Hospital of Traditional Chinese Medicine | Suzhou | Jiangsu | 215600 | China |
| NIS-Wuxi 2nd People's Hospital | Wuxi | Jiangsu | 214000 | China |
| NIS-No.2 Hospital Affiliated to Jilin University | Changchun | Jilin | 130041 | China |
| NIS-The 1st Affi. Hosp. of Changchun Univer. of Chinese Medi | Changchun | Jilin | 150040 | China |
| NIS-People's Hospital of Liaoning Province | Shenyang | Liaoning | 110016 | China |
| NIS-Shenyang Central Hospital | Shenyang | Liaoning | 110024 | China |
| NIS-The Affiliated Hospital of Liaoning TCM University | Shenyang | Liaoning | 110032 | China |
| NIS-The 4th Affiliated Hospital of China Medical University | Shenyang | Liaoning | 110084 | China |
| NIS- Qinghai Red Cross Hospital | Xining | Qinghai | 810099 | China |
| NIS-Heping Hospital Affiliated to Changzhi Medical College | Changzhi | Shaanxi | 046000 | China |
| NIS-Second Hospital of Shanxi Medical University | Taiyuan | Shaanxi | 030001 | China |
| NIS-Affiliated Hospital of Shanxi TCM Colleage | Xianyang | Shaanxi | 712000 | China |
| NIS-Affiliated Hospital of Shanxi Yanan Medical Colleage | Yan’an | Shaanxi | 716000 | China |
| NIS-Weifang People's Hospital | Weifang | Shandong | 261000 | China |
| NIS-Shanxi Provincial People's Hospital | Taiyuan | Shanxi | 030012 | China |
| NIS-No.1 Hospital affiliated to Shihezi Medical College | Shihezi | Xinjiang | 832008 | China |
| NIS-Xinjiang Traditional Chinese Medicine Hospital | Ürümqi | Xinjiang | 510170 | China |
| NIS-The 5th Affiliated Hospital of Xinjiang Medical Univ. | Ürümqi | Xinjiang | 830000 | China |
| NIS-The 2nd Affiliated Hospital of Xinjiang Medical Univer. | Ürümqi | Xinjiang | 830028 | China |
| NIS-The First Affiliated Hospital of Xinjiang Medical Univ. | Ürümqi | Xinjiang | 830054 | China |
| NIS-Dali First People's Hospital | Dali | Yunnan | 671000 | China |
| NIS-The Second Affiliated Hospital of Kunming Medical Univ. | Kunming | Yunnan | 650101 | China |
| NIS-Ningbo First Hospital | Ningbo | Zhejiang | 315010 | China |
| NIS-The No.2 Hospital affiliated to Guizhou Medical college | Kaili | 556000 | China |
| NIS-People's Hospital of Qinghai Province | Xining | 810007 | China |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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