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

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La sperimentazione clinica NCT02429258 è stata uno studio interventistico di Fase IV condotto per esaminare il trattamento per Diabete di tipo II, attualmente completato. Avviato il 1 maggio 2015, ha previsto l'arruolamento di 226 partecipanti. Sotto la guida di AstraZeneca, si è concluso il 1 ottobre 2015. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 14 giugno 2017.
Sommario breve
Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin
Descrizione dettagliata
Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin
Titolo ufficiale

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

Patologie
Diabete di tipo II
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
  • D1690L00026
Numero NCT
NCT02429258
Data di inizio (effettiva)
2015-05
Ultimo aggiornamento pubblicato
2017-06-14
Data di completamento (stimata)
2015-10
Arruolamento (previsto)
226
Tipo di studio
Interventistico
FASE
Fase IV
Stato
Completato
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Triplo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleFarxiga with metformin or insulin
Farxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
Farxiga
Farxiga 10mg/day
Metformina
Metformin background therapy \>/= 1500mg/day
Insulina
Insulin \>/= 30 units
Comparatore placeboPlacebo with metformin or insulin
Placebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications
PLACEBO
Placebo
Metformina
Metformin background therapy \>/= 1500mg/day
Insulina
Insulin \>/= 30 units
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • 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

California

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

Florida

Research Site, Cooper City, Florida, United States
Research Site, Miami, Florida, United States

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
Research Site, Rochester, New York, United States

North Carolina

Research Site, Greensboro, North Carolina, United States

Ohio

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

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