Basalog® is similar to Lantus® in producing glycemic control in patients with type 1 diabetes mellitus on multiple daily insulin regimens
| Autor: | A. Arun, Manish Verma, M. N. Dixit, A. Eswaraiah, P. Hazra, S. Akundi, C. G. Prasanna, A. Atignal, Harish Iyer |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
medicine.medical_specialty
Type 1 diabetes Insulin glargine business.industry Endocrinology Diabetes and Metabolism Insulin medicine.medical_treatment Hypoglycemia medicine.disease Surgery Diabetes mellitus Internal medicine Internal Medicine medicine In patient business Adverse effect medicine.drug Glycemic |
| Zdroj: | International Journal of Diabetes in Developing Countries. 31:26-31 |
| ISSN: | 1998-3832 0973-3930 |
| DOI: | 10.1007/s13410-010-0010-2 |
| Popis: | This study was performed to compare the insulin glargine produced by two different manufacturers. The study determines the efficacy and safety of a new insulin glargine (Basalog®) having the same amino-acid sequence as Lantus® in patients with type 1 diabetes mellitus on multiple daily insulin regimen. After a run-in period of 4 weeks on once-daily Lantus®, patients were randomized in 1:1 ratio to receive once-daily treatment with either Basalog® (n = 107) or Lantus® (n = 108) for 12 weeks in this open-label multicenter study. Patients were enrolled from 15 hospitals in India. Change in HbA1c was the primary efficacy parameter; FPG, 7-point glucose profile and PPG were the secondary efficacy parameters. Hypoglycemia and immunogenicity were the main safety parameters. This was a non-inferiority study where non-inferiority could be claimed if mean difference (including 95% CI) was less than or equal to 0.5% for the primary efficacy parameter HbA1c. There was no statistically significant difference between the groups with respect to change in HbA1c (p = 0.69), FPG (p = 0.25) or PPG (p = 0.68). The change in HbA1c from baseline to end-point was 7.86 ± 1.11 to 7.80 ± 1.24% in Basalog® treated patients and 7.76 ± 1.17 to 7.58 ± 1.27% in Lantus® treated patients. Proportion of patients achieving HbA1c |
| Databáze: | OpenAIRE |
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