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Similar glycaemic control and less hypoglycaemia during active titration after insulin initiation with glargine 300 units/mL and degludec 100 units/mL: A subanalysis of the BRIGHT study.
Cheng, Alice; Harris, Stewart; Giorgino, Francesco; Seufert, Jochen; Ritzel, Robert; Khunti, Kamlesh; Lauand, Felipe; Melas-Melt, Lydie; Westerbacka, Jukka; Bosnyak, Zsolt; Rosenstock, Julio.
Afiliação
  • Cheng A; Department of Medicine, University of Toronto, Toronto, Canada.
  • Harris S; Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
  • Giorgino F; Department of Emergency and Organ Transplantation, Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy.
  • Seufert J; Division of Endocrinology and Diabetology, Department of Medicine II, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.
  • Ritzel R; Division of Endocrinology, Diabetes and Angiology, Klinikum Schwabing and Klinikum Bogenhausen, Munich, Germany.
  • Khunti K; Diabetes Research Centre, University of Leicester, Leicester, UK.
  • Lauand F; Sanofi, Paris, France.
  • Melas-Melt L; IVIDATA, Levallois-Perret, France.
  • Westerbacka J; Sanofi, Paris, France.
  • Bosnyak Z; Sanofi, Paris, France.
  • Rosenstock J; Dallas Diabetes Research Center at Medical City, Dallas, Texas, United States.
Diabetes Obes Metab ; 22(3): 346-354, 2020 03.
Article em En | MEDLINE | ID: mdl-31646724
ABSTRACT

AIM:

To further investigate glycaemic control and hypoglycaemia in BRIGHT, focusing on the titration period. MATERIALS AND

METHODS:

BRIGHT was a multicentre, open-label, randomized, active-controlled, two-arm, parallel-group, 24-week study in insulin-naïve patients with uncontrolled type 2 diabetes initiated on glargine 300 U/mL (Gla-300) (N = 466) or degludec (IDeg-100) (N = 463). Predefined efficacy and safety outcomes were investigated during the initial 12-week titration period. In addition, patients' characteristics and clinical outcomes were assessed descriptively, stratified by confirmed (≤3.9 mmol/L) hypoglycaemia incidence during the initial titration period.

RESULTS:

At week 12, HbA1c was comparable between Gla-300 (7.32%) and IDeg-100 (7.23%), with similar least squares (LS) mean reductions from baseline (-1.37% and - 1.39%, respectively; LS mean difference of 0.02; 95% confidence interval -0.08 to 0.12). Patients who experienced hypoglycaemia during the initial titration period had numerically greater HbA1c reductions by week 12 than patients who did not (-1.46% vs. -1.28%), and higher incidence of anytime (24 hours; 73.3% vs. 35.7%) and nocturnal (0000-0600 hours; 30.0% vs. 11.9%) hypoglycaemia between weeks 13-24.

CONCLUSIONS:

The use of Gla-300 resulted in similar glycaemic control as IDeg-100 during the initial 12-week titration period of the BRIGHT study, when less anytime (24 hours) hypoglycaemia with Gla-300 versus IDeg-100 has been reported. Experiencing hypoglycaemia shortly after initiating Gla-300 or IDeg-100 may be associated with hypoglycaemia incidence in the longer term, potentially impacting glycaemic management.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Diabetes Mellitus Tipo 2 / Hipoglicemia Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: Diabetes Obes Metab Assunto da revista: ENDOCRINOLOGIA / METABOLISMO Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Canadá

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Diabetes Mellitus Tipo 2 / Hipoglicemia Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: Diabetes Obes Metab Assunto da revista: ENDOCRINOLOGIA / METABOLISMO Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Canadá