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Clinical Trial Details

Trial ID: L7128
Source ID: NCT01128153
Associated Drug: Saxagliptin
Title: Saxagliptin Triple Oral Therapy
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01128153/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Saxagliptin|DRUG: Placebo
Outcome Measures: Primary: Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF), Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model, From Baseline to Week 24 weeks | Secondary: Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL], Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model, From Baseline to Week 24|Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L], Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model, From Baseline to Week 24|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL], Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance, From Baseline to Week 24|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L], Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model, From Baseline to Week 24|Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF), Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24, From Baseline to Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 257
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2010-06
Completion Date: 2011-06
Results First Posted: 2012-08-03
Last Update Posted: 2012-08-10
Locations: Research Site, Broadmeadow, New South Wales, Australia|Research Site, Wollongong, New South Wales, Australia|Research Site, Daw Park, South Australia, Australia|Research Site, Elizabeth Vale, South Australia, Australia|Research Site, Melbourne, Victoria, Australia|Research Site, Camperdown, Australia|Research Site, Herston, Australia|Research Site, St. John's, Newfoundland and Labrador, Canada|Research Site, Sydney Mines, Nova Scotia, Canada|Research Site, Thornhill, Ontario, Canada|Research Site, Kensington, Prince Edward Island, Canada|Research Site, Karnal, Haryana, India|Research Site, Bangalore, Karnataka, India|Research Site, Indore, Madhya Pradesh, India|Research Site, Pune, Maharashtra, India|Research Site, Coimbatore, Tamil Nadu, India|Research Site, Wonju, Kangwon-do, Korea, Republic of|Research Site, Goyang, Kyounggi-do, Korea, Republic of|Research Site, Daegu, Korea, Republic of|Research Site, Seoul, Korea, Republic of|Research Site, Bangkok, Thailand|Research Site, Reading, Berks, United Kingdom|Research Site, ELY, Cambridgeshire, United Kingdom|Research Site, Whitstable, Kent, United Kingdom|Research Site, Westbury, Wiltshire, United Kingdom|Research Site, Ashford, United Kingdom|Research Site, Belfast, United Kingdom|Research Site, Blackpool, United Kingdom|Research Site, Chesterfield, United Kingdom|Research Site, Coventry, United Kingdom|Research Site, Glasgow, United Kingdom|Research Site, Peterborough, United Kingdom|Research Site, Wellingborough, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01128153

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