Study on efficacy and safety of using NovoMix 30 for type 2 diabetes: result from China cohort in PRESENT study
- VernacularTitle:诺和锐(R)30治疗2型糖尿病有效性和安全性研究——PRESENT大型临床观察研究中国区结果报道
- Author:
Yan GAO
;
Xinohui GUO
- Publication Type:Journal Article
- Keywords:
Diabetes mellitus,type 2;
Drug therapy;
Insulin
- From:Chinese Journal of Endocrinology and Metabolism
2008;24(6):616-619
- CountryChina
- Language:Chinese
-
Abstract:
Objective The PRESENT ( Physicians' Routine Evaluation of Safety and Efficacy of NovoMix 30 Therapy) study is a multinational clinical experience program to report the efficacy, safety and acceptability of NovoMix 30 (BlAsp 30) in patients with type 2 diabetes mellitus inadequately controlled with oral antidiabetic drugs (OADs). Methods A total of 4 754 type 2 diabetes patients inadequately controlled with oral antidiabetic drugs were enrolled in the study. All patients were prescribed BIAsp 30 in accordance with the approved labeling. Data were collected at baseline and at the end of 3 months treatment. Results The mean HbA1c, body mass index (BMI), age, and duration were (9.09±1.70)%, (24.30±2.68)kg/m2, (54.63±10.94)years, and (5.46 ±4.17) years separately. The mean daily dose was (0.43±0.14) U/kg at treatment initiation and (0.48±0.15) U/kg after 3 months treatment. After 3 months, the mean HbA1c, fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) were significantly reduced from baseline levels. The mean HbA1c decreased by (2.04± 1.57)%, FPG by a (3.51±2.55)retool/L, and PPG by a (6.51±4.02) mmol/L (all P<0.01). A significant proportion (49.4%) of the patients achieved target HbA1c of ≤7%. The overall rate of hypoglycaemic episodes (events/patient-yr) decreased from 10. 098 at baseline to 3. 810 at study end. The rate of major hypoglycaemia decreased from 0. 787 to 0.126, and the rate of nocturnal hypoglycaemia decreased from 2.356 to 0.547. Compared with previous treatment, more than 99% of the patients and physicians were "satisfied" or "very satisfied" with BIAsp 30 treatment. Conclusions BIAsp 30 was found to be safe and effective to improve the glycaemia control of type 2 diabetes inadequately controlled with OADs in routine clinical practice.
