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Clinical Trial Details

Trial ID: L5713
Source ID: NCT00698932
Associated Drug: Saxagliptin
Title: Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00698932/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Saxagliptin|DRUG: Placebo
Outcome Measures: Primary: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c), Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication., Baseline , Week 24 | Secondary: Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG), Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication., Baseline, Week 24|Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG), Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication., Baseline, Week 24|Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants, Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication, Baseline , Week 24|Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants, Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication, Baseline , Week 24|Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24, Proportion of participants (expressed in percentage of total participants) achieving HbA1c \< 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication, Baseline, Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 568
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2008-06
Completion Date: 2009-10
Results First Posted: 2011-09-21
Last Update Posted: 2011-09-21
Locations: Research Site, Hefei, Anhui, China|Research Site, Fuzhou, Fujian, China|Research Site, Guangzhou, Guangdong, China|Research Site, Shijiazhuang, Hebei, China|Research Site, Changsha, Hunan, China|Research Site, Nanjing, Jiangsu, China|Research Site, Changchun, Jilin, China|Research Site, Dalian, Liaoning, China|Research Site, Shenyang, Liaoning, China|Research Site, Shanghai, Shanghai, China|Research Site, Chengdu, Sichuan, China|Research Site, Hangzhou, Zhejiang, China|Research Site, Beijing, China|Research Site, Chongqing, China|Research Site, Tianjin, China|Research Site, Hyderabaad, Andhra Pradesh, India|Research Site, Bangalore, Karnataka, India|Research Site, Mangalore, Karnataka, India|Research Site, Mumbai, Maharashtra, India|Research Site, Nagpur, Maharashtra, India|Research Site, Pune, Maharashtra, India|Research Site, Coimbatore, India|Research Site, Jeonju, Chonbuk, Korea, Republic of|Research Site, Daegu, Korea, Republic of|Research Site, Seoul, Korea, Republic of|Research Site, Cebu City, Philippines|Research Site, Makati City, Philippines|Research Site, Manila, Philippines|Research Site, Marikina City, Philippines|Research Site, Quezon City, Philippines
URL: https://clinicaltrials.gov/show/NCT00698932