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Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin Phase 4 226

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Die klinische Studie NCT02429258 untersuchte Behandlung im Zusammenhang mit Typ-II-Diabetes. Diese interventionsstudie der Phase 4 hat den Status abgeschlossen. Die Studie begann am 1. Mai 2015 mit 226 Teilnehmern. Sie wurde durchgeführt von AstraZeneca und am 1. Oktober 2015 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 14. Juni 2017 aktualisiert.
Kurzbeschreibung
Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin
Ausführliche Beschreibung
Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin
Offizieller Titel

Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

Erkrankungen
Typ-II-Diabetes
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • D1690L00026
NCT-Nummer
NCT02429258
Studienbeginn (tatsächlich)
2015-05
Zuletzt aktualisiert
2017-06-14
Studienende (vorauss.)
2015-10
Geplante Rekrutierung
226
Studientyp
Interventionsstudie
PHASE
Phase 4
Status
Abgeschlossen
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Dreifach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellFarxiga 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-VergleichspräparatPlacebo 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
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System
Baseline to Week 4
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4
Baseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population
Baseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population
Baseline to Week 4
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population
Baseline to Week 4
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4
Baseline to Week 4
Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4
Baseline to Week 4
Change in HbA1c From Baseline to Week 4
Baseline to Week 4
Change in Fructosamine From Baseline to Week 4
Baseline to Week 4
Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4
Baseline to Week 4
Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population
Baseline to Week 4
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • Type 2 diabetes mellitus (T2DM)
  • 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

  • For patients who enter the study taking a stable dose of metformin, history of taking OAD medications other than metformin during the 8 weeks prior to screening or have been on insulin therapy within 1 year of screening
  • 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
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Alabama

Research Site, Birmingham, Alabama, United States

Arizona

Research Site, Phoenix, Arizona, United States

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Research Site, Huntington Park, California, United States
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Research Site, San Diego, California, United States
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Florida

Research Site, Cooper City, Florida, United States
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Illinois

Research Site, Evanston, Illinois, United States

Maryland

Research Site, Oxon Hill, Maryland, United States

Nebraska

Research Site, Henderson, Nebraska, United States

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Research Site, Brooklyn, New York, United States
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North Carolina

Research Site, Greensboro, North Carolina, United States

Ohio

Research Site, Cincinnati, Ohio, United States
Research Site, Dublin, Ohio, United States
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Oregon

Research Site, Eugene, Oregon, United States

Pennsylvania

Research Site, Lansdale, Pennsylvania, United States

South Carolina

Research Site, Spartanburg, South Carolina, United States

Tennessee

Research Site, Bartlett, Tennessee, United States

Texas

Research Site, Dallas, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Hurst, Texas, United States

Washington

Research Site, Renton, Washington, United States