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Clinical Trial Details

Trial ID: L2722
Source ID: NCT05221580
Associated Drug: Ryzodeg®
Title: China Research of IDEgAsp Treatment in Real-world Clinical practicE (CREATE)
Acronym: CREATE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Ryzodeg®
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c), Percentage point, From baseline (week 0) to end of study (week 20 to 32) | Secondary: HbA1c less than 7 percent (Yes/No), Percentage of patients, 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, 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, From baseline (week 0) to end of study (week 20 to 32)|Change in insulin dose (total, basal, prandial), units/day, From baseline (week 0) to end of study (week 20 to 32)|Change in body weight, Kg, 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, 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), At baseline and end of study (week 20 to 32)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 887
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2022-03-18
Completion Date: 2023-03-31
Results First Posted:
Last Update Posted: 2024-06-14
Locations: NIS-The Second People's Hospital of Hefei, Hefei, Anhui, 230012, China|NIS-Beijing Hospital, Beijing, Beijing, 100005, China|NIS-Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, 100050, China|NIS-People's Hospital of Chongqing Banan District, Chongqing, Chongqing, 400320, China|NIS-Gansu Provincial People's Hospital, Lanzhou, Gansu, 730000, China|NIS-The people's hospital of JiangMen, Jiangmen, Guangdong, 529020, China|NIS-2nd Affiliated Hospital of Shantou University Medical, Shantou, Guangdong, 515041, China|NIS-Shenzhen Longgang District People's Hospital, Shenzhen, Guangdong, 518172, China|NIS-Yangjiang People's Hospital, Yangjiang, Guangdong, 529500, China|NIS-The First People's Hospital of Yulin City, Yulin, Guangxi, 37000, China|NIS-Hainan Provincial Hospital of TCM, Haikou, Hainan, 570203, China|NIS-Cangzhou Hosp of Integrated Traditional Chinese Medicine, Cangzhou, Hebei, 061013, China|NIS-The First Hospital of Handan, Handan, Hebei, 056002, China|NIS-The First Hospital of Qinhuangdao, Qinhuangdao, Hebei, 066000, China|NIS-Heilongjiang Provincial Hospital, Harbin, Heilongjiang, 150036, China|NIS-Zhengzhou University - The Second Affiliated Hospital, Zhengzhou, Henan, 450014, China|NIS-Shiyan City People's Hospital, Shiyan, Hubei, 442099, China|NIS-Puai Hospital of Wuhan, Wuhan, Hubei, 430000, China|NIS-The Third Xiangya Hospital of Central South University, Changsha, Hunan, 410013, China|NIS-The Sceond Hospital of Chifeng, Chifeng, Inner Mongolia Autonomous Region, 024099, China|NIS-Inner Mongolia University for Nationalities - Affiliated, Tongliao, Inner Mongolia Autonomous Region, 028000, China|NIS-Changshu Second People's Hospital, Changshu, Jiangsu, 215501, China|NIS-Huai'an First People's Hospital, Huai'an, Jiangsu, 223300, China|NIS-Nanjing Jiangning Hospital, Nanjing, Jiangsu, 211199, China|NIS-Jiangsu Province Officeial Hospital, Nanjing, Jiangsu, 320100, China|NIS-Nantong University - Affiliated Hospital, Nantong, Jiangsu, 226006, China|NIS-Yixing City People's Hospital, Yixing, Jiangsu, 214200, China|NIS-Affiliated Hospital of Jilin Medical College, Jilin, Jilin, 132013, China|NIS-Songyuan Jilin Oilfield Hospital, Songyuan, Jilin, 138000, China|NIS-The Third People's Hospital of Dalian, Dalian, Liaoning, 116033, China|NIS-Huludao Central Hospital, Huludao, Liaoning, 125000, China|NIS-Third Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, 121012, China|NIS-The Fourth Hospital of China Medical University, Shenyang, Liaoning, 110032, China|NIS-The People's Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia Hui Autonomous Region, 750021, China|NIS- Qinghai Red Cross Hospital, Xining, Qinghai, 810099, China|NIS-Hanzhong Central Hospital, Hanzhong, Shaanxi, 723000, China|NIS-Shanxi Bethune Hospital, Taiyuan, Shaanxi, 030032, China|NIS-Xi'an No.3 Hospital, Xi'an, Shaanxi, 710018, China|NIS-Weifang Medical University - Affiliated Hospital, Weifang, Shandong, 261035, China|NIS-Binzhou Medical University-Yantai Affiliated Hospital, Yantai, Shandong, 256699, China|NIS-Central hospital of zibo, Zhibo, Shandong, 255036, China|NIS-Shanghai Shidong Hospital, Shanghai, Shanghai, 200433, China|NIS-Shanghai Shuguang Hospital, Shanghai, Shanghai, 201203, China|NIS-Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, 637000, China|NIS-Metabolic Diseases Hosp&Tianjin Institute of Endocrinolo, Tianjin, Tianjin, 300070, China|NIS-Tianjin First Center Hospital, Tianjin, Tianjin, 300190, China|NIS-De Hong Zhou People's Hospital, Mang, Yunnan, 678400, China|NIS-The First People's Hospital of Qujing, Qujing, Yunnan, 655099, China|NIS-Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, China|NIS-Shaoxing Central Hospital, Shaoxing, Zhejiang, 312030, China
URL: https://clinicaltrials.gov/show/NCT05221580

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