Insulin lispro low mixture twice daily versus basal insulin glargine once daily and prandial insulin lispro once daily in patients with type 2 diabetes requiring insulin intensification: a randomized phase IV trial
| Autor: | J. L. Gross, Simon Cleall, A. Onaca, A. Rodríguez, Francisco J. Tinahones |
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| Rok vydání: | 2014 |
| Předmět: |
Blood Glucose
Male medicine.medical_specialty endocrine system diseases insulin lispro mixture Endocrinology Diabetes and Metabolism medicine.medical_treatment Population Insulin Glargine Type 2 diabetes insulin intensification Gastroenterology Drug Administration Schedule Endocrinology Internal medicine Internal Medicine medicine Humans Hypoglycemic Agents Insulin lispro education Meals Glycated Hemoglobin education.field_of_study Insulin Lispro Pioglitazone business.industry Insulin glargine Insulin Original Articles Middle Aged medicine.disease Hypoglycemia Metformin Insulin Long-Acting Treatment Outcome Diabetes Mellitus Type 2 Tolerability Female Thiazolidinediones type 2 diabetes business medicine.drug |
| Zdroj: | Diabetes, Obesity & Metabolism |
| ISSN: | 1463-1326 1462-8902 |
| DOI: | 10.1111/dom.12303 |
| Popis: | Aims To compare the efficacy and safety of two insulin intensification strategies in patients with type 2 diabetes inadequately controlled on basal insulin glargine with metformin and/or pioglitazone. Methods A multinational, randomized, open-label trial that compared insulin lispro low mixture (LM25; n = 236) twice daily with a basal–prandial regimen of insulin glargine once daily and insulin lispro once daily (IGL; n = 240) over 24 weeks in patients with HbA1c 7.5–10.5% and fasting plasma glucose ≤6.7 mmol/l. The primary objective was to assess non-inferiority [per-protocol (PP) population], and then superiority [intention-to-treat (ITT) population], of LM25 versus IGL according to change in HbA1c after 24 weeks (non-inferiority margin 0.4%, two-sided significance level 0.05). Results Estimated change [least squares (LS) mean (95% CI)] in HbA1c after 24 weeks: −1.30 (−1.44, −1.16)% with LM25 and −1.08 (−1.22, −0.94)% with IGL. Non-inferiority was shown [LS mean (95% CI) HbA1c treatment difference −0.21 (−0.38, −0.04) (PP population)]; gated superiority assessment showed a statistically significant advantage for LM25 (p = 0.010; ITT population). Mean blood glucose, glycaemic variability, overall tolerability and hypoglycaemic episodes per patient-year did not show significant differences between treatments during the study. Conclusions In patients with type 2 diabetes inadequately controlled on once-daily basal insulin glargine and metformin and/or pioglitazone, intensification with LM25 was superior to a basal–prandial approach in terms of reduction in HbA1c after 24 weeks and did not increase hypoglycaemia episodes. |
| Databáze: | OpenAIRE |
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