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

NCT04227431 | Completed

• 2 other identifiers: NN1250-4442U1111-1208-5180
• Study Type: observational
• Target: 938
• Locations: 1 country
• Sites: 56

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in glycosylated haemoglobin (HbA1c)

  Percent point

  Week 0, week 20

Secondary Outcomes (7)

• Change in laboratory-measured fasting plasma glucose (FPG)

  From baseline (week 0) to end of study (week 20)

• Change in self-measured fasting plasma glucose (SMPG)

  From baseline (week 0) to end of study (week 20)

• Change in daily insulin doses (total, basal, prandial)

  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®

  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)

  From baseline (week 0) to end of study (week 20)

Study Arms (1)

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®

Other: Insulin degludec

Interventions

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.

Tresiba®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (56)

NIS-The Second Hospital of Anhui Medical Hospital

Hefei, Anhui, 230601, China

Location

NIS-No.9 People's Hospital of Chongqing

Chongqing, Chongqing Municipality, 400700, China

Location

NIS-The Third Affiliated Hospital of Chongqing Medical Univ.

Chongqing, Chongqing Municipality, 401120, China

Location

NIS-People's Hospital of Gansu Province

Lanzhou, Gansu, 730000, China

Location

NIS-People's Hospital of Linxia, Gansu

Linxia, Gansu, 731100, China

Location

NIS-Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

NIS-The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

NIS-Huizhou Third People's Hospital

Huizhou, Guangdong, 516002, China

Location

NIS-Qingyuan People's Hospital

Qingyuan, Guangdong, 511518, China

Location

NIS-Shenzhen Futian District People's Hospital

Shenzhen, Guangdong, 518033, China

Location

NIS-The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, 518053, China

Location

NIS-General Hospital of Shenzhen University

Shenzhen, Guangdong, 518055, China

Location

NIS-Hainan Provincial Hospital of TCM

Haikou, Hainan, 570203, China

Location

NIS-People's Hospital of Henan Province

Zhengzhou, Hainan, 450003, China

Location

NIS-Cangzhou Central Hospital

Cangzhou, Hebei, 061001, China

Location

NIS-Dingzhou People's Hospital

Dingzhou, Hebei, 073099, China

Location

NIS-CNPC Central Hospital

Langfang, Hebei, 065000, China

Location

NIS-Langfang people's Hospital

Langfang, Hebei, 065000, China

Location

NIS-The 3rd Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

Location

NIS-Haerbin 1st Hospital

Harbin, Heilongjiang, 150000, China

Location

NIS-The Second Affiliated Hospital of Harbin Medical Univ.

Harbin, Heilongjiang, 150001, China

Location

NIS-Heilongjiang Provincial Hospital

Harbin, Heilongjiang, 150036, China

Location

NIS-The First Affiliated Hospital, Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

NIS-General Hospital of Shiyan Dongfeng Group

Shiyan, Hubei, 442000, China

Location

NIS-Changzhou No.2 People's Hospital

Changzhou, Jiangsu, 213003, China

Location

NIS-Kunshan 1st People's Hospital

Kunshan, Jiangsu, 215300, China

Location

NIS-Nanjing Jiangbei Hospital

Nanjing, Jiangsu, 210000, China

Location

NIS-The Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210008, China

Location

NIS-Zhong Da Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

NIS-Nanjing Jiangning Hospital

Nanjing, Jiangsu, 211199, China

Location

NIS-The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

NIS-Zhangjiagang Hospital of Traditional Chinese Medicine

Suzhou, Jiangsu, 215600, China

Location

NIS-Wuxi 2nd People's Hospital

Wuxi, Jiangsu, 214000, China

Location

NIS-No.2 Hospital Affiliated to Jilin University

Changchun, Jilin, 130041, China

Location

NIS-The 1st Affi. Hosp. of Changchun Univer. of Chinese Medi

Changchun, Jilin, 150040, China

Location

NIS-People's Hospital of Liaoning Province

Shenyang, Liaoning, 110016, China

Location

NIS-Shenyang Central Hospital

Shenyang, Liaoning, 110024, China

Location

NIS-The Affiliated Hospital of Liaoning TCM University

Shenyang, Liaoning, 110032, China

Location

NIS-The 4th Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110084, China

Location

NIS- Qinghai Red Cross Hospital

Xining, Qinghai, 810099, China

Location

NIS-Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shaanxi, 046000, China

Location

NIS-Second Hospital of Shanxi Medical University

Taiyuan, Shaanxi, 030001, China

Location

NIS-Affiliated Hospital of Shanxi TCM Colleage

Xianyang, Shaanxi, 712000, China

Location

NIS-Affiliated Hospital of Shanxi Yanan Medical Colleage

Yan’an, Shaanxi, 716000, China

Location

NIS-Weifang People's Hospital

Weifang, Shandong, 261000, China

Location

NIS-Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

Location

NIS-No.1 Hospital affiliated to Shihezi Medical College

Shihezi, Xinjiang, 832008, China

Location

NIS-Xinjiang Traditional Chinese Medicine Hospital

Ürümqi, Xinjiang, 510170, China

Location

NIS-The 5th Affiliated Hospital of Xinjiang Medical Univ.

Ürümqi, Xinjiang, 830000, China

Location

NIS-The 2nd Affiliated Hospital of Xinjiang Medical Univer.

Ürümqi, Xinjiang, 830028, China

Location

NIS-The First Affiliated Hospital of Xinjiang Medical Univ.

Ürümqi, Xinjiang, 830054, China

Location

NIS-Dali First People's Hospital

Dali, Yunnan, 671000, China

Location

NIS-The Second Affiliated Hospital of Kunming Medical Univ.

Kunming, Yunnan, 650101, China

Location

NIS-Ningbo First Hospital

Ningbo, Zhejiang, 315010, China

Location

NIS-The No.2 Hospital affiliated to Guizhou Medical college

Kaili, 556000, China

Location

NIS-People's Hospital of Qinghai Province

Xining, 810007, China

Location

Related 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. doi: 10.1007/s13300-024-01533-6. Epub 2024 Mar 5.

  PMID: 38438707 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 13, 2020
• Study Start: January 17, 2020
• Primary Completion: July 17, 2021
• Study Completion: July 17, 2021
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (56)