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Comparative Effectiveness and Safety of Different Basal Insulins in a Real World Setting.

Comparative Effectiveness and Safety of Different Basal Insulins in a Real World Setting.
Author Information (click to view)

Ji L, Zhang P, Zhu D, Lu J, Guo X, Wu Y, Li X, Ji J, Jia W, Yang W, Zou D, Zhou Z, Gao Y, Garg SK, Pan C, Weng J, Paul SK, ,


Ji L, Zhang P, Zhu D, Lu J, Guo X, Wu Y, Li X, Ji J, Jia W, Yang W, Zou D, Zhou Z, Gao Y, Garg SK, Pan C, Weng J, Paul SK, , (click to view)

Ji L, Zhang P, Zhu D, Lu J, Guo X, Wu Y, Li X, Ji J, Jia W, Yang W, Zou D, Zhou Z, Gao Y, Garg SK, Pan C, Weng J, Paul SK, ,

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Diabetes, obesity & metabolism 2017 02 23() doi 10.1111/dom.12920
Abstract
AIMS
To compare glucose control and safety of different basal insulin (BI, including Insulin NPH, glargine and detemir) therapies in real-life clinical settings based on a large-scale registry study.

METHODS
In this multi-center 6-month prospective observational study, patients with type 2 diabetes uncontrolled (HbA1c≥7%) by oral anti-diabetic drugs (OADs) and willing to initiate BI were enrolled from 209 hospitals of eight regions of China. Type and dose of BI were at the physician’s discretion and patients’ willingness. Interviews were conducted at 0 month-visit 1, 3 months-visit 2, and 6 months-visit 3. Outcomes included the change of HbA1c, hypoglycemia rate and body weight from baseline at 6 months.

RESULTS
16 341 and 9 002 subjects were used in Intention-To-Treat (ITT) and per-protocol (PP) analysis, respectively. After the PS regression adjustment, the ITT analysis showed that the reduction of HbA1c in glargine (2 · 2 ± 2 · 1%) and detemir groups (2 · 2 ± 2 · 1%) was higher than that in NPH group (2 · 0 ± 2 · 2 %) (P < 0.01). Detemir group had the lowest weight gain (-0 · 1 ± 2 · 9kg) compared with glargine (+0 · 1 ± 3 · 0kg) and NPH group (+0 · 3 ± 3 · 1kg) (p < 0 · 05). Glargine group had the lowest rate of minor hypoglycemia while there was no difference in severe hypoglycemia among the three groups. The results observed in PP analyses were consistent with those in ITT analysis. CONCLUSION
In a real-world clinical setting in China, long-acting insulin analogues treatment were associated with better glycemic control as well as less hypoglycemia and weight gain than NPH insulin in type 2 diabetes patients. However, the clinical relevance of these observations need to be interpreted with caution.

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