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Clinical Trial Details

Trial ID: L4162
Source ID: NCT01608724
Associated Drug: Saxagliptin
Title: The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
Acronym: SUNSHINE
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01608724/results
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Interventions: DRUG: Saxagliptin
Outcome Measures: Primary: Absolute Change From Baseline in Haemoglobin A1c (HbA1c), Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise., Weeks 6, 12, and 24 | Secondary: Proportion (%) of Patients Achieving HbA1c <7%, Weeks 6, 12, and 24|Change From Baseline in Fasting Plasma Glucose (FPG), Weeks 6, 12, 18, and 24|Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG), Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 2165
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-11
Completion Date: 2014-05
Results First Posted: 2016-02-02
Last Update Posted: 2016-02-02
Locations: Research Site, Baotou, China|Research Site, Beijing, China|Research Site, Benxi, China|Research Site, Changchun, China|Research Site, Chengdu, China|Research Site, Chongqing, China|Research Site, Dalian, China|Research Site, Dongguan, China|Research Site, Foshan, China|Research Site, Fuzhou, China|Research Site, Guangzhou, China|Research Site, Guiyang, China|Research Site, Haikou, China|Research Site, Hangzhou, China|Research Site, Hhht, China|Research Site, Hubei, China|Research Site, Jimo, China|Research Site, Jinan, China|Research Site, Kunming, China|Research Site, Linyi, China|Research Site, Nanjing, China|Research Site, Nantong, China|Research Site, Qingdao, China|Research Site, Shanghai, China|Research Site, Shantou, China|Research Site, Shenyang, China|Research Site, Shiyan, China|Research Site, Suzhou, China|Research Site, Taiyuan, China|Research Site, Tianjin, China|Research Site, Urumqi, China|Research Site, Wenzhou, China|Research Site, Wuhan, China|Research Site, Wuxi, China|Research Site, Xian, China|Research Site, Zhanjiang, China|Research Site, Zhengzhou, China
URL: https://clinicaltrials.gov/show/NCT01608724

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D447 Saxagliptin small molecule DB06335 Details