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  • Mathieu, C. (författare)

Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes (the DEPICT-2 Study): 24-Week Results From a Randomized Controlled Trial

  • Artikel/kapitelEngelska2018

Förlag, utgivningsår, omfång ...

  • 2018-07-19
  • American Diabetes Association,2018

Nummerbeteckningar

  • LIBRIS-ID:oai:gup.ub.gu.se/271938
  • https://gup.ub.gu.se/publication/271938URI
  • https://doi.org/10.2337/dc18-0623DOI

Kompletterande språkuppgifter

  • Språk:engelska

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  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • OBJECTIVEThis 24-week, double-blinded, phase 3 clinical trial (DEPICT-2; ClinicalTrials.gov, NCT02460978) evaluated efficacy and safety of dapagliflozin as adjunct therapy to adjustable insulin in patients with inadequately controlled type 1 diabetes (HbA(1c) 7.5-10.5%).RESEARCH DESIGN AND METHODSPatients were randomized 1:1:1 to dapagliflozin 5 mg (n = 271), dapagliflozin 10 mg (n = 270), or placebo (n = 272) plus insulin. Insulin dose was adjusted by investigators according to self-monitored glucose readings, local guidance, and individual circumstances.RESULTSBaseline characteristics were balanced between treatment groups. At week 24, dapagliflozin significantly decreased HbA(1c) (primary outcome; difference vs. placebo: dapagliflozin 5 mg -0.37% [95% CI -0.49, -0.26], dapagliflozin 10 mg -0.42% [-0.53, -0.30]), total daily insulin dose (-10.78% [-13.73, -7.72] and -11.08% [-14.04, -8.02], respectively), and body weight (-3.21% [-3.96, -2.45] and -3.74% [-4.49, -2.99], respectively) (P < 0.0001 for all). Mean interstitial glucose, amplitude of glucose excursion, and percent of readings within target glycemic range (>70 to 180 mg/dL) versus placebo were significantly improved. More patients receiving dapagliflozin achieved a reduction in HbA(1c) 0.5% without severe hypoglycemia compared with placebo. Adverse events were reported for 72.7%, 67.0%, and 63.2% of patients receiving dapagliflozin 5 mg, dapagliflozin 10 mg, and placebo, respectively. Hypoglycemia, including severe hypoglycemia, was balanced between groups. There were more adjudicated definite diabetic ketoacidosis (DKA) events with dapagliflozin: 2.6%, 2.2%, and 0% for dapagliflozin 5 mg, dapagliflozin 10 mg, and placebo, respectively.CONCLUSIONSDapagliflozin as adjunct therapy to adjustable insulin in patients with type 1 diabetes was well tolerated and improved glycemic control with no increase in hypoglycemia versus placebo but with more DKA events.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Dandona, P. (författare)
  • Gillard, P. (författare)
  • Senior, P. (författare)
  • Hasslacher, C. (författare)
  • Araki, E. (författare)
  • Lind, Marcus,1976Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine(Swepub:gu)xostem (författare)
  • Bain, S. C. (författare)
  • Jabbour, S. (författare)
  • Arya, N. (författare)
  • Hansen, L. (författare)
  • Thoren, F. (författare)
  • Langkilde, A. M. (författare)
  • Göteborgs universitetInstitutionen för medicin (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Diabetes Care: American Diabetes Association41:9, s. 1938-19460149-59921935-5548

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