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Clinical Trial Details

Trial ID: L2960
Source ID: NCT02104804
Associated Drug: Saxagliptin 5mg
Title: Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02104804/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Saxagliptin 5mg|DRUG: Placebo for Saxagliptin
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 24, Baseline to 24 weeks | Secondary: Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test, Baseline to 24 weeks|Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test, Baseline to 24 weeks|Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7%, At Week 24|The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24), Baseline to Average of Weeks 20 and 24|Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24, Baseline to 24 weeks
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 953
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-05-07
Completion Date: 2016-02-26
Results First Posted: 2017-10-02
Last Update Posted: 2017-10-02
Locations: Research Site, Beijing, China|Research Site, Changchun, China|Research Site, Fuzhou, China|Research Site, Guangzhou, China|Research Site, Ha'er bing, China|Research Site, Hefei, China|Research Site, Nanchang, China|Research Site, Nanjing, China|Research Site, Shanghai, China|Research Site, ShiJiazhuang, China|Research Site, Shiyan, China
URL: https://clinicaltrials.gov/show/NCT02104804

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