Efficacy and safety of basal insulin degludec 100 IU/mL versus glargine 300 IU/mL for type 1 diabetes: The single-center INEOX randomized controlled trial.
Diabetes Res Clin Pract
; 196: 110238, 2023 Feb.
Article
em En
| MEDLINE
| ID: mdl-36610544
ABSTRACT
AIMS:
To compare efficacy and safety of degludec 100 IU/mL (Deg-100) and glargine 300 IU/mL (Gla-300) in adults with type 1 diabetes.METHODS:
Open-label, single-center, randomized, parallel-group, 24-week trial in adults with type 1 diabetes, on basal-bolus insulin therapy, HbA1c ≤ 10%, using self-monitoring blood glucose. Participants were randomized 11 to a basal-bolus insulin regimen with Deg-100 (N = 129) or Gla-300 (N = 131). Primary efficacy endpoint mean change in HbA1c from baseline to week-24. Main safetyoutcome:
incidence rate of hypoglycemia during the study. Quality of life (DQOL) and satisfaction with diabetes treatment (DTSQ) were assessed.RESULTS:
At week 24, after adjusting for baseline HbA1c, the decrease in HbA1c did not differ between groups Deg-100 (-0.07 ± 0.7%) and Gla-300 (-0.16 ± 0.77%) (P = 0.320). There were no significant differences between groups in HbA1c, nocturnal hypoglycemia, severe hypoglycemia, DQOL, or DTSQ scores. The incidence rates of hypoglycemia < 3.9 mmol/L (Deg-100 115.24 events/person-year vs Gla-300 99.01 events/person-year, p < 0.001); and < 3.0 mmol/L (Deg-100 41.17 events/person-year vs Gla-300 34.29 events/person-year, p < 0.001) were different between groups.CONCLUSIONS:
Deg-100 and Gla-300 have similar metabolic efficacy, incidence ratio of nocturnal and severe hypoglycemia, DQOL and DTSQ scores. Differences in the incidence rate of hypoglycemia < 3.9 mmol/L and < 3.0 mmol/L should be confirmed.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Diabetes Mellitus Tipo 1
/
Hipoglicemia
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Hipoglicemiantes
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article