Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
NCT ID: NCT02429258
Last Updated: 2017-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
226 participants
INTERVENTIONAL
2015-05-31
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Farxiga with metformin or insulin
Farxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Farxiga
Farxiga 10mg/day
Metformin
Metformin background therapy \>/= 1500mg/day
Insulin
Insulin \>/= 30 units
Placebo with metformin or insulin
Placebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Placebo
Placebo
Metformin
Metformin background therapy \>/= 1500mg/day
Insulin
Insulin \>/= 30 units
Interventions
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Farxiga
Farxiga 10mg/day
Placebo
Placebo
Metformin
Metformin background therapy \>/= 1500mg/day
Insulin
Insulin \>/= 30 units
Eligibility Criteria
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Inclusion Criteria
* Treated with either stable dose of metformin alone \> or = to 1500mg/day or stable dose of insulin \> or = to 30 units/day and up to 2 OAD medications for at least 8 weeks
* Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening
* Body mass index (BMI) \< or = to 45 kg/m2
Exclusion Criteria
* For patients who enter the study taking insulin, history of taking any other therapy outside of the stable insulin and up to 2 OAD medications for 8 weeks prior to screening.
* Use of sulfonylureas during the 8 weeks prior to screening
* Prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (SGLT-2) inhibitor
* Ingestion of any medication know to affect glucose metabolism for \>7 consecutive days during the 3 months prior to screening
* Ingestion of prescription or over the counter weight loss medication during 3 months prior to screening
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Huntington Park, California, United States
Research Site
Los Angeles, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
West Hills, California, United States
Research Site
Cooper City, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Evanston, Illinois, United States
Research Site
Oxon Hill, Maryland, United States
Research Site
Henderson, Nebraska, United States
Research Site
Brooklyn, New York, United States
Research Site
Rochester, New York, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Dublin, Ohio, United States
Research Site
Franklin, Ohio, United States
Research Site
Eugene, Oregon, United States
Research Site
Lansdale, Pennsylvania, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Bartlett, Tennessee, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Hurst, Texas, United States
Research Site
Renton, Washington, United States
Countries
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References
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Henry RR, Strange P, Zhou R, Pettus J, Shi L, Zhuplatov SB, Mansfield T, Klein D, Katz A. Effects of Dapagliflozin on 24-Hour Glycemic Control in Patients with Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Technol Ther. 2018 Nov;20(11):715-724. doi: 10.1089/dia.2018.0052. Epub 2018 Sep 14.
Other Identifiers
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D1690L00026
Identifier Type: -
Identifier Source: org_study_id
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