Randomized, 1-year comparison of three ways to initiate and advance insulin for type 2 diabetes: twice-daily premixed insulin versus basal insulin with either basal-plus one prandial insulin or basal-bolus up to three prandial injections.
Diabetes Obes Metab
; 16(5): 396-402, 2014 May.
Article
em En
| MEDLINE
| ID: mdl-24118931
ABSTRACT
AIM:
Many patients with type 2 diabetes mellitus (T2DM) initiate insulin therapy when other treatments fail; how best to do this is poorly defined.METHODS:
People with T2DM [n = 588; glycated haemoglobin A1C (A1C) >7.0%, mean baseline 9.4%] were randomized to twice-daily premixed protamine-aspart/aspart insulin (PM - 2), once-daily insulin glargine plus zero to one prandial insulin glulisine injection (G + 1), or insulin glargine plus zero to three prandial injections (G + 3). Insulin was titrated for 60 weeks. Efficacy and safety outcomes were assessed.RESULTS:
Discontinuation rates were 53 of the 194 (27%), 44 of the 194 (23%) and 38 of the 194 (20%), for PM - 2, G + 1 and G + 3. Glycaemic control improved in all groups (A1C 7.2 ± 1.37, 7.1 ± 1.68 and 7.0 ± 1.21% at 60 weeks; 7.5 ± 1.29, 7.2 ± 1.62 and 7.2 ± 1.63% at endpoint). G + 1 was statistically non-inferior to PM - 2 in reducing A1C. G + 3 was slightly superior to PM - 2 in attaining <7.0% at 60 weeks, but only when the analysis included Good Clinical Practice non-adherent sites. Hypoglycaemia with plasma glucose <2.8 mmol/l was more frequent with PM - 2 versus G + 1 and G + 3; [adjusted incidence 46 (p = 0.0087) vs. 33 (p = 0.0045) and 31.5%; events per patient-year 1.9 vs. 0.8 and 0.9, p ≤ 0.0001]. Insulin dosage and weight-gain were similar.CONCLUSION:
Basal insulin plus a single prandial injection is as effective in improving glycaemic control as premixed insulin. Full basal-prandial therapy is only slightly more effective than premixed insulin. Stepwise basal-prandial regimens improve glycaemic control with less hypoglycaemia than twice-daily premixed insulin.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Compostos de Sulfonilureia
/
Glicemia
/
Hemoglobinas Glicadas
/
Tiazolidinedionas
/
Diabetes Mellitus Tipo 2
/
Hipoglicemiantes
/
Insulina
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Diabetes Obes Metab
Assunto da revista:
ENDOCRINOLOGIA
/
METABOLISMO
Ano de publicação:
2014
Tipo de documento:
Article
País de afiliação:
Estados Unidos