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Clinical Trial Details

Trial ID: L6018
Source ID: NCT02273050
Associated Drug: Saxagliptin 5 Mg
Title: Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02273050/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Saxagliptin 5 mg|DRUG: Placebo 5 mg for Saxagliptin|DRUG: Placebo 500 mg for metformin (with titration)|DRUG: Metformin 500 mg with titration
Outcome Measures: Primary: Change From Baseline in HbA1c From Baseline to Week 24 Provided That it is Prior to Rescue, To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in HbA1c (%) at the end of 24 weeks of double-blinded treatment., Baseline to Week 24 (prior to rescue) | Secondary: Glycemic Response Defined as HbA1c < 7.0% at Week 24, To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c \< 7.0% at the end of 24 weeks of double-blinded treatment., Week 24 (prior to rescue)|Change From Baseline to Week 24 (Prior to Rescue) in Fasting Plasma Glucose, To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in fasting plasma glucose at the end of 24 weeks of double-blinded treatment., Baseline to Week 24 prior to rescue|Change From Baseline to Week 24 (Prior to Rescue) in Area Under the Curve From 0-180 Minutes for Postprandial Glucose Response to a Meal Tolerance Test, To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 180-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment., Baseline to Week 24 prior to rescue|Glycemic Response Defined as HbA1c ≤ 6.5% at Week 24, To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c ≤ 6.5% at the end of 24 weeks of double-blinded treatment., Week 24 (prior to rescue)|Change From Baseline to Week 24 in 120-minute Postprandial Glucose Response to a Meal Tolerance Test, To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 120-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment., Baseline to Week 24 prior to rescue|Patients Rescued for Failing to Achieve Pre-specified Glycemic Targets or Discontinuation for Lack of Efficacy During the 24-week Double-blind Treatment Phase, To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24 weeks of double-blinded treatment., Baseline to Week 24
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1136
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-12
Completion Date: 2016-08
Results First Posted: 2018-02-05
Last Update Posted: 2018-02-05
Locations: Research Site, Beijing, China|Research Site, Changchun, China|Research Site, Chuangchun, China|Research Site, Fuzhou, China|Research Site, Guiyang, China|Research Site, Ha'er bin, China|Research Site, Hangzhou, China|Research Site, Hefei, China|Research Site, Jinan, China|Research Site, Nanchang, China|Research Site, Nanjing, China|Research Site, Shanghai, China|Research Site, Shijiazhuang, China|Research Site, Siping, China|Research Site, Tianjin, China|Research Site, Wuxi, China|Research Site, Yueyang, China
URL: https://clinicaltrials.gov/show/NCT02273050