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Chinese Journal of Endocrinology and Metabolism ; (12): 564-571, 2016.
Article Dans Chinois | WPRIM | ID: wpr-496195

Résumé

Objective To investigate the efficacy of biphasic insulin aspart 50(BIAsp50)twice daily(bid) versusbiphasichumaninsulin50(BHI50)(bid)plusmetforminonbloodglucosecontrolfollowingastandardmealtest in Chinese patients with type 2 diabetes mellitus(T2DM). Methods A randomized, open-label, 2-sequence, crossover trial for two 4-week treatment periods was conducted in 14 Chines institutes. Eligible subjects inadequately controlled with BHI50(bid)plus metformin were randomized to two sequences in a 1 : 1 ratio(A:BIAsp50-BHI50, B:BHI50-BIAsp50 ) . Standard meal tests were performed at baseline and the ends of two periods within 4 weeks. Primary endpoint was 2h postprandial plasma glucose ( PPG) increment following standard meal test, with insulin dose standardized at 0. 3 IU/kg. Results A total of 161 subjects were randomized into two sequences(81 to sequence A, and 80 to sequence B) and finally analysed. After 4 weeks of treatment, mean 2h PPG increment with BIAsp50 was lower than that with BHI50 [ treatment difference of BIAsp50 vs BHI50: -1. 12 mmol/L ( 95% CI-1. 66,-0. 58), P<0. 01], suggesting superiority of BIAsp50 over BHI50. Incremental area under the curve for PPG(0-2 h)with BIAsp50 was lower than that with BHI50 [treatment difference:-38. 8 mmol·L-1·min-1(95%CI-77. 3,-0. 26), P=0. 049], as was the mean 2h PPG [treatment difference:-0. 58 mmol/L(95% CI -1. 13,-0. 03), P=0. 040]. The FPG value with BIAsp50 was higher than that with BHI50 [treatment difference:0. 52 mmol/L(95%CI 0. 18, 0. 86), P=0. 003]. The rate of nocturnal hypoglycemia with BIAsp50 was lower than that with BHI50(1. 13 vs 2. 86 events per subject year, P<0. 01). Conclusion In patients with T2DM inadequately controlled with BHI50 plus metformin, BIAsp50 was proven to be well-tolerated with improved postprandial glucose control compared with BHI50.

2.
Chinese Journal of Diabetes ; (12): 189-192, 2015.
Article Dans Chinois | WPRIM | ID: wpr-460966

Résumé

[Summary] The characteristic feature of glucose profiles is high postprandial plasma glucose in Chinese T2DM patients. IDF Guideline recommends that T2DM patients whose postprandial plasma glucose cannot beadequately controlled by oral antidiabetic drugs ,should combine premixed insulin for treatment. Containing 50% insulin formulation for rapid action and 50% that for intermediate action ,mid‐ratio premix insulin analogues show exceptional characteristic of pharmacokinetics ,are able to efficiently improve high postprandial plasma glucose ,and ,with the route of administration flexible and convenience , can enhance patient compliance. Mid‐ratio premix insulin analogues can be one of the optimal option for T2DM treatment.

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