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  • Takahashi, Y. (author)

Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency

  • Article/chapterEnglish2022

Publisher, publication year, extent ...

  • 2022-11-15
  • Springer Science and Business Media LLC,2022

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  • LIBRIS-ID:oai:gup.ub.gu.se/322336
  • https://gup.ub.gu.se/publication/322336URI
  • https://doi.org/10.1007/s11102-022-01283-3DOI

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  • Language:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

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  • Purpose The long-term effects of long-acting growth hormone (LAGH) analogues on glucose metabolism in adult growth hormone deficiency (AGHD) are not known. We investigated the impact of LAGH somapacitan, administered once-weekly, on glucose metabolism in patients with AGHD. Methods In post hoc-defined analyses, we compared the effects of somapacitan with daily growth hormone (GH) and placebo on fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and beta-cell function (HOMA-beta) in patients with AGHD across a unique data set from three phase 3 randomized controlled trials (REAL 1, REAL 2 and REAL Japan). Results No new cases of diabetes mellitus were reported with somapacitan. Among GH-naive patients (n = 120 somapacitan, n = 119 daily GH), higher changes from baseline in FPG, HOMA-IR and fasting insulin levels were observed with daily GH versus somapacitan at 34 weeks, but not at 86 weeks. HbA1c and HOMA-beta did not differ between groups at either timepoint. Among treatment-naive patients, sex, age, fasting insulin, glucose tolerance status and body mass index did not influence changes in glucose metabolism. In previously treated patients (REAL 1 extension: n = 51 somapacitan, n = 52 daily GH; REAL 2: n = 61 and n = 31, respectively; REAL Japan: n = 46 and n = 16, respectively), the difference in changes from baseline were not statistically significant between somapacitan and daily GH for any glucose metabolism parameters. Conclusions Somapacitan, compared with daily GH, did not adversely affect glucose metabolism up to 86 weeks in a large cohort of treatment-naive or previously treated patients with AGHD. Trial registrations (date of registration): NCT02229851 (2 September 2014), NCT02382939 (3 March 2015), NCT03075644 (7 March 2017).

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  • Biller, B. M. K. (author)
  • Fukuoka, H. (author)
  • Ho, K. K. Y. (author)
  • Rasmussen, M. H. (author)
  • Nedjatian, N. (author)
  • Svaerke, C. (author)
  • Yuen, K. C. J. (author)
  • Johannsson, Gudmundur,1960Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine(Swepub:gu)xjgudn (author)
  • Göteborgs universitetInstitutionen för medicin (creator_code:org_t)

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  • In:Pituitary: Springer Science and Business Media LLC1386-341X1573-7403

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By the author/editor
Takahashi, Y.
Biller, B. M. K.
Fukuoka, H.
Ho, K. K. Y.
Rasmussen, M. H.
Nedjatian, N.
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Svaerke, C.
Yuen, K. C. J.
Johannsson, Gudm ...
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About the subject
MEDICAL AND HEALTH SCIENCES
MEDICAL AND HEAL ...
and Clinical Medicin ...
and Endocrinology an ...
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Pituitary
By the university
University of Gothenburg

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