| Trial ID: | L4058 |
| Source ID: | NCT03608358
|
| Associated Drug: |
Dapagliflozin 10 Mg
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| Title: |
Safety and Efficacy of Dapagliflozin in Asian T2DM Subjects With Inadequate Glycemic Control on Metformin/Saxagliptin
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| Acronym: |
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| Status: |
TERMINATED
|
| Study Results: |
NO
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| Results: |
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| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Dapagliflozin 10 mg|DRUG: Dapagliflozin 5 mg|DRUG: Dapagliflozin 10 mg placebo to match|DRUG: Dapagliflozin 5 mg placebo to match|DRUG: Saxagliptin 5 mg|DRUG: Metformin
|
| Outcome Measures: |
Primary: Mean change from baseline in HbA1c at Week 24, To compare the mean change from baseline in HbA1c achieved with dapagliflozin 5 mg or dapagliflozin 10 mg added to saxagliptin 5 mg plus metformin versus placebo added to saxagliptin 5 mg plus metformin after 24 weeks of oral administration of double-blind treatment, Baseline to Week 24 | Secondary: Mean change from baseline in fasting plasma glucose (FPG) at Week 24, To compare the mean change from baseline in FPG achieved with dapagliflozin 5 mg or dapagliflozin 10 mg added to saxagliptin 5 mg plus metformin versus placebo added to saxagliptin 5 mg plus metformin after 24 weeks of oral administration of double-blind treatment, Baseline to Week 24|Mean change in 2-hour postprandial glucose during a meal tolerance test (2-hour MTT) at Week 24, To compare the mean change from baseline in 2-hour postprandial glucose from a meal tolerance test (2-hour MTT) achieved with dapagliflozin 5 mg or dapagliflozin 10 mg added to saxagliptin 5 mg plus metformin versus placebo added to saxagliptin 5 mg plus metformin after 24 weeks of oral administration of double-blind treatment, Baseline to Week 24|Mean change from baseline in total body weight at Week 24, To compare the mean change from baseline in total body weight achieved with dapagliflozin 5 mg or dapagliflozin 10 mg added to saxagliptin 5 mg plus metformin versus placebo added to saxagliptin 5 mg plus metformin after 24 weeks of oral administration of double-blind treatment, Baseline to Week 24|Percent of subjects achieving a therapeutic glycaemic response of HbA1c <7.0% at Week 24, To compare the proportion of subjects achieving a therapeutic glycaemic response of HbA1c \< 7.0% with dapagliflozin 5 mg or dapagliflozin 10 mg added to saxagliptin 5 mg plus metformin vs. placebo added to saxagliptin 5 mg plus metformin after 24 weeks of oral administration of double-blind treatment, At week 24
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| Sponsor/Collaborators: |
Sponsor: AstraZeneca
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
41
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-02-27
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| Completion Date: |
2020-08-04
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| Results First Posted: |
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| Last Update Posted: |
2022-05-31
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| Locations: |
Research Site, Bangkok, 10330, Thailand|Research Site, Bangkok, 10400, Thailand|Research Site, Ho Chi Minh, 10000, Vietnam|Research Site, Ho Chi Minh, 700000, Vietnam
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| URL: |
https://clinicaltrials.gov/show/NCT03608358
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