Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Patients with Type 2 Diabetes (Begin: Compare).
Endocr Pract
; 20(8): 785-91, 2014 Aug.
Article
em En
| MEDLINE
| ID: mdl-24518180
ABSTRACT
OBJECTIVE:
The purpose of the present study was to provide clinical data on the efficacy and safety of insulin degludec (IDeg) 200 U/mL compared with IDeg 100 U/mL in patients with type 2 diabetes mellitus (T2DM) currently treated with basal insulin in combination with oral antidiabetic drugs.METHODS:
In this 22-week, treat-to-target trial, eligible adult patients with T2DM were randomized 11 to IDeg 200 or IDeg 100 U/mL once daily (OD) (n = 186 and 187, respectively). The starting insulin dose was based on a 11 transfer of the total prerandomization basal insulin dose. The primary endpoint was change (%) from baseline in glycosylated hemoglobin A1C (A1C) after 22 weeks of treatment.RESULTS:
A total of 373 subjects (mean age 59.8 years, A1C 8.2%, fasting plasma glucose 149.6 mg/dL [8.3 mmol/L], body mass index 33.3 kg/m2) were randomized. A1C reduction with IDeg 200 U/mL was noninferior to that of IDeg 100 U/mL (IDeg 200 U/mL - IDeg 100 U/mL estimated treatment difference -0.11%, 95% confidence interval (CI) -0.28 to 0.05). Rates of overall confirmed hypoglycemia were low and similar between both formulations (5.17 and 5.66 events/patient-year of exposure [PYE] for IDeg 200 and 100 U/mL, respectively). Similarly, the rates of nocturnal confirmed hypoglycemia were low (1.27 and 1.70 events/PYE for 200 and 100 U/mL). In general, both IDeg formulations were well tolerated (respective rates of adverse events 4.16 and 3.00 events/PYE for 200 and 100 U/mL).CONCLUSION:
The 200 and 100 U/mL formulations of IDeg provide comparable and effective levels of glycemic control with similar, low rates of overall confirmed and nocturnal confirmed hypoglycemia.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Insulina de Ação Prolongada
/
Diabetes Mellitus Tipo 2
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Hipoglicemiantes
Tipo de estudo:
Clinical_trials
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Endocr Pract
Ano de publicação:
2014
Tipo de documento:
Article