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SHR Neuro Cancer Cardio Lipid Metab Microb
Rodbard, HW; Cariou, B; Pieber, TR; Endahl, LA; Zacho, J; Cooper, JG.
Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial.
Diabetes Obes Metab. 2016; 18(3):274-280
Doi: 10.1111/dom.12609
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- Co-authors Med Uni Graz
- Pieber Thomas
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- Abstract:
- To evaluate the efficacy and safety of two insulin intensification strategies for patients with type 2 diabetes previously treated with basal insulin--insulin degludec (IDeg) and insulin aspart (IAsp)--administered as a co-formulation (IDegAsp) or as a basal-bolus regimen (IDeg and IAsp in separate injections). This 26-week, open-label, treat-to-target, phase IIIb, non-inferiority trial randomized patients (1 : 1) to IDegAsp twice daily with main meals (n = 138; IDegAsp group) or IDeg once daily and IAsp 2-4 times daily (n = 136; IDeg+IAsp group). After 26 weeks, the mean glycated haemoglobin (HbA1c) level was 7.0% (53 mmol/mol) for the IDegAsp group and 6.8% (51 mmol/mol) for the IDeg+IAsp group (Δ%HbA1c from baseline -1.31 and -1.50%, respectively). The non-inferiority of IDegAsp versus IDeg+IAsp was not confirmed for mean change in HbA1c [estimated treatment difference (ETD) 0.18, 95% confidence interval (CI) -0.04, 0.41; p = non-significant]. No significant differences were observed in the proportion of patients achieving HbA1c <7.0% (56.5 and 59.6%, respectively). IDegAsp treatment resulted in a significantly lower total daily insulin dose, a smaller change in body weight, numerically lower rates of confirmed hypoglycaemia (self-reported plasma glucose <3.1 mmol/l; rate ratio 0.81; p = non-significant), and nocturnal confirmed hypoglycaemic episodes (rate ratio 0.80; p = non-significant) versus IDeg+IAsp. Patient-reported outcome scores for social functioning were significantly higher for IDegAsp versus IDeg+IAsp (ETD 2.2; 95% CI 0.3, 4.1; p < 0.05). Both intensification strategies effectively improved glycaemic control. Although non-inferiority was not confirmed, there were no significant differences between the groups that could affect clinical utility. © 2015 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Blood Glucose - analysis
- Body Weight - drug effects
- Diabetes Mellitus, Type 2 - blood
- Diabetes Mellitus, Type 2 - drug therapy
- Dose-Response Relationship, Drug -
- Drug Administration Schedule -
- Drug Combinations -
- Drug Therapy, Combination -
- Female -
- Glycated Hemoglobin A - drug effects
- Humans -
- Hypoglycemia - chemically induced
- Hypoglycemic Agents - administration & dosage
- Insulin Aspart - administration & dosage
- Insulin Detemir - administration & dosage
- Insulin, Long-Acting - administration & dosage
- Male -
- Meals -
- Middle Aged -
- Find related publications in this database (Keywords)
- efficacy
- insulin aspart
- insulin degludec
- insulin intensification
- type 2 diabetes