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P-33 Thrice daily biphasic insulin aspart 30 regimen: another therapeutic option for Chinese patients with Type 2 diabetes
DIABETES RESEARCH A N D CLINICAL PRACTICE
79 (2008) S1 – S127
S67
Conclusions: Improving PPG and HbA1c were cited as reasons for switching a high proportion of patients from BHI 30 to BIAsp 30, which suggests dissatisfaction with BHI 30 as a means of achieving glycaemic control. A mean HbA1c of 8.8% and a high percentage of patients with macrovascular (41.3%) and microvascular (56.8%) complications support the conclusion that historical glycaemic control in this population is unsatisfactory.
tively. There was no significant difference in major and minor hypoglycaemic episodes between both regimens. Risk of nocturnal hypoglycaemic events was also similar in both regimens (relative risk (RR) = 0.81, p = 0.51), while TID regimen revealed a significantly lower risk of diurnal hypoglycaemic events (RR = 0.58, p = 0.02). The same safety profile in terms of hypoglycaemic episodes was also observed in patients achieving IDF target (HbA1c ≤ 6.5%). Moreover, the hypoglycaemic episodes were most frequently seen between 10:00-12:00 am in BID regimen compared with those seen in TID regimen. There was no significant difference in weight gain in the two regimens. Comments/Conclusions: BID BIAsp 30, as the known effective treatment regimen, demonstrates once again its good efficacy and safety in glycaemic control in Chinese patients with T2D inadequately controlled with oral agents. However, if patients have a habit of eating a rich lunch and simple breakfast and are willing to receive one more injection per day, TID BIAsp 30 regimen could be another therapeutic option, with an improved overall glycaemic control and lower risk of diurnal hypoglycaemic episodes, without an increase in the insulin dose per body weight.
P-33
P-34
Thrice daily biphasic insulin aspart 30 regimen: another therapeutic option for Chinese patients with Type 2 diabetes
Comparison of 2-h postprandial blood glucose excursion (PPBG) in response to a standard test meal in insulin-requiring patients with diabetes treated twice daily with insulin Lispro Mix 50 or human insulin Mix 50
Reason to start BIAsp 30 N Improve post-prandial blood glucose Improve HbA1c Improve fasting blood glucose Reduce risk of hypoglycaemia Allow for mealtime administration Patient dissatisfaction with previous therapy Easy intensification of insulin therapy Easy start of insulin therapy Side effects from previous therapy Change ue to insulin pen
Total sample 155 79% 76% 65% 61% 54% 47% 45% 32% 10% 10%
Wenying Yang 1 , Qiuhe Ji 2 , Dalong Zhu 3 , Jinkui Yang 4 , Lulu Chen 5 , Zhimin Liu 6 , Demin Yu 7 , Li Yan 8 1 China-Japan Friendship Hospital, Beijing, 2 Xijing Hospital, Xi’an, 3 Nanjing Drum Tower Hospital, Nanjing, 4 Beijing Tongren Hospital, Beijing, 5 Wuhan Union Hospital, Wuhan, 6 Shanghai Changzheng Hospital, Shanghai, 7 Metabolic Disease Hospital, Tianjin, 8 Sun Yixian Commemorative Hospital, Guangzhou, China Aims: To compare the efficacy and safety of thrice-daily (TID) biphasic insulin aspart 30 (BIAsp 30) with that of twice-daily (BID) BIAsp 30 in order to determine whether TID BIAsp 30 is another therapeutic option other than BID BIAsp 30 for Chinese patients with Type 2 diabetes (T2D), inadequately controlled with oral agents. Methods: In this 24-week, randomized, open-label, parallel group trial, insulin naive patients with T2D (pre-breakfast blood glucose (BG) ≥ 7.8 mmol/L and HbA1c ≥ 7.5%) failing to achieve glycaemic control with oral agents were randomized in a 1:1 manner to receive either BID BIAsp 30 or TID BIAsp 30. The dose distribution of daily insulin at initiation was 50-50% (before breakfast and dinner) in BID regimen and 25-25-50% (before breakfast, lunch and dinner) in TID regimen. Insulin dose was adjusted according to the titration algorithm to achieve the premeal BG target of 4.4-6.1 mmol/L. Change in HbA1c , pre-meal self monitored BG (SMBG), 2-hour post-breakfast BG, hypoglycaemic episodes, total daily insulin dose, insulin dose distribution and some other parameters were assessed and analysed. Results: There were 321 patients randomized. The baseline characteristics of the subjects were comparable in the two regimens with a baseline HbA1c and fasting BG of around 9.5% and 11.5 mmol/L, respectively. After 24 weeks, HbA1c decreased significantly in both regimens (BID: -2.5%; TID: -2.8%). TID regimen showed superiority in HbA1c improvement (-0.34%, 95% CI: [-0.53;-0.13], p < 0.01). The proportion of patients achieving IDF target (HbA1c ≤ 6.5%) was 34.4% and 46.6% in BID and TID regimen, respectively. Two-hour post-breakfast BG and pre-lunch SMBG at each visit showed no significant difference between the two regimens, while significant lower pre-dinner SMBG was noted in TID regimen. The mean daily insulin dose was 0.82 U/kg in BID regimen and 0.86 U/kg in TID regimen at the end of treatment and the dose distribution before each main meal was 0.49:0.51 and 0.33:0.25:0.42 in BID and TID regimen, respec-
Yan Gao 1 , Guangwei Li 2 , Yan Li 3 , Xiaohui Guo 1 , Geheng Yuan 1 , Qiuhong Gong 2 , Li Yan 3 , Yiman Zheng 4 , Jia Zhang 4 1 Peking University First Hospital, Dept of Endocrinology, Beijing, CN, 2 Sino-Japan Friendship Hospital, Dept of Endocrinology, Beijng, CN, 3 The 2nd Affiliated Hospital of Sun Yat-sen University, Dept of Endocrinology, Guangzhou, CN, 4 Eli Lilly Asia, Inc. Shanghai, China Background and aims: Patients with higher PPBG or with carbohydrate-rich meals may benefit from insulin lispro mix 50 (LM50; 50% insulin lispro; 50% insulin lispro protamine suspension). We compared the 2-h PPBG excursion following a standard test meal in Chinese patients with Type 1 or Type 2 diabetes treated twice daily with human insulin mix 50 (HI50) versus LM50. Materials and methods: This was a multicenter, randomized, open-label, crossover study. Patients with either Type 1 or Type 2 diabetes (n=120) treated with HI50 or human insulin mix 30 twice daily, with an HbA1c between 1.1 to 1.7 times of the upper limit of the normal range, were randomized to 12 weeks of treatment with LM50 followed by 12 weeks of treatment with HI50 (before breakfast and dinner in both), or the reverse sequence. No oral anti-diabetes medicines were used within the 2 months prior to entering the study and during the treatment period. 2h-PPBG and excursion, following a standard test breakfast with 460 calories, and HbA1c value were assessed at baseline and endpoint of each treatment. Fasting blood glucose (FBG) level, insulin dose, and safety data were obtained at each visit. A crossover analysis using SAS Proc Mixed was employed to compare the two regimens. Results: One hundred and fifteen patients (57 in sequence lLM50/HI50, 58 in HI50/LM50) completed the study. Mean 2-h PPBG excursion (primary objective) decreased from 6.32±2.965 mM at baseline to 3.47±2.966 mM in the LM50 group, and from 6.32±2.965 mM to 5.02±3.324 mM in the HI50 group at endpoint of each treatment (P<0.001 in overall comparison). No significant difference was observed between treatment groups in HbA1c level (7.59% in LM50, 7.61% in HI50; P=0.581) and insulin doses (P=0.690). At endpoint, mean FBG was significantly higher with LM50 than with HI50 (9.78 mM vs 9.10 mM; P=0.023). No serious adverse events were related to the study drug; one occurred during treatment with LM50 and two with HI50. The
79 (2008) S1 – S127
S67
Conclusions: Improving PPG and HbA1c were cited as reasons for switching a high proportion of patients from BHI 30 to BIAsp 30, which suggests dissatisfaction with BHI 30 as a means of achieving glycaemic control. A mean HbA1c of 8.8% and a high percentage of patients with macrovascular (41.3%) and microvascular (56.8%) complications support the conclusion that historical glycaemic control in this population is unsatisfactory.
tively. There was no significant difference in major and minor hypoglycaemic episodes between both regimens. Risk of nocturnal hypoglycaemic events was also similar in both regimens (relative risk (RR) = 0.81, p = 0.51), while TID regimen revealed a significantly lower risk of diurnal hypoglycaemic events (RR = 0.58, p = 0.02). The same safety profile in terms of hypoglycaemic episodes was also observed in patients achieving IDF target (HbA1c ≤ 6.5%). Moreover, the hypoglycaemic episodes were most frequently seen between 10:00-12:00 am in BID regimen compared with those seen in TID regimen. There was no significant difference in weight gain in the two regimens. Comments/Conclusions: BID BIAsp 30, as the known effective treatment regimen, demonstrates once again its good efficacy and safety in glycaemic control in Chinese patients with T2D inadequately controlled with oral agents. However, if patients have a habit of eating a rich lunch and simple breakfast and are willing to receive one more injection per day, TID BIAsp 30 regimen could be another therapeutic option, with an improved overall glycaemic control and lower risk of diurnal hypoglycaemic episodes, without an increase in the insulin dose per body weight.
P-33
P-34
Thrice daily biphasic insulin aspart 30 regimen: another therapeutic option for Chinese patients with Type 2 diabetes
Comparison of 2-h postprandial blood glucose excursion (PPBG) in response to a standard test meal in insulin-requiring patients with diabetes treated twice daily with insulin Lispro Mix 50 or human insulin Mix 50
Reason to start BIAsp 30 N Improve post-prandial blood glucose Improve HbA1c Improve fasting blood glucose Reduce risk of hypoglycaemia Allow for mealtime administration Patient dissatisfaction with previous therapy Easy intensification of insulin therapy Easy start of insulin therapy Side effects from previous therapy Change ue to insulin pen
Total sample 155 79% 76% 65% 61% 54% 47% 45% 32% 10% 10%
Wenying Yang 1 , Qiuhe Ji 2 , Dalong Zhu 3 , Jinkui Yang 4 , Lulu Chen 5 , Zhimin Liu 6 , Demin Yu 7 , Li Yan 8 1 China-Japan Friendship Hospital, Beijing, 2 Xijing Hospital, Xi’an, 3 Nanjing Drum Tower Hospital, Nanjing, 4 Beijing Tongren Hospital, Beijing, 5 Wuhan Union Hospital, Wuhan, 6 Shanghai Changzheng Hospital, Shanghai, 7 Metabolic Disease Hospital, Tianjin, 8 Sun Yixian Commemorative Hospital, Guangzhou, China Aims: To compare the efficacy and safety of thrice-daily (TID) biphasic insulin aspart 30 (BIAsp 30) with that of twice-daily (BID) BIAsp 30 in order to determine whether TID BIAsp 30 is another therapeutic option other than BID BIAsp 30 for Chinese patients with Type 2 diabetes (T2D), inadequately controlled with oral agents. Methods: In this 24-week, randomized, open-label, parallel group trial, insulin naive patients with T2D (pre-breakfast blood glucose (BG) ≥ 7.8 mmol/L and HbA1c ≥ 7.5%) failing to achieve glycaemic control with oral agents were randomized in a 1:1 manner to receive either BID BIAsp 30 or TID BIAsp 30. The dose distribution of daily insulin at initiation was 50-50% (before breakfast and dinner) in BID regimen and 25-25-50% (before breakfast, lunch and dinner) in TID regimen. Insulin dose was adjusted according to the titration algorithm to achieve the premeal BG target of 4.4-6.1 mmol/L. Change in HbA1c , pre-meal self monitored BG (SMBG), 2-hour post-breakfast BG, hypoglycaemic episodes, total daily insulin dose, insulin dose distribution and some other parameters were assessed and analysed. Results: There were 321 patients randomized. The baseline characteristics of the subjects were comparable in the two regimens with a baseline HbA1c and fasting BG of around 9.5% and 11.5 mmol/L, respectively. After 24 weeks, HbA1c decreased significantly in both regimens (BID: -2.5%; TID: -2.8%). TID regimen showed superiority in HbA1c improvement (-0.34%, 95% CI: [-0.53;-0.13], p < 0.01). The proportion of patients achieving IDF target (HbA1c ≤ 6.5%) was 34.4% and 46.6% in BID and TID regimen, respectively. Two-hour post-breakfast BG and pre-lunch SMBG at each visit showed no significant difference between the two regimens, while significant lower pre-dinner SMBG was noted in TID regimen. The mean daily insulin dose was 0.82 U/kg in BID regimen and 0.86 U/kg in TID regimen at the end of treatment and the dose distribution before each main meal was 0.49:0.51 and 0.33:0.25:0.42 in BID and TID regimen, respec-
Yan Gao 1 , Guangwei Li 2 , Yan Li 3 , Xiaohui Guo 1 , Geheng Yuan 1 , Qiuhong Gong 2 , Li Yan 3 , Yiman Zheng 4 , Jia Zhang 4 1 Peking University First Hospital, Dept of Endocrinology, Beijing, CN, 2 Sino-Japan Friendship Hospital, Dept of Endocrinology, Beijng, CN, 3 The 2nd Affiliated Hospital of Sun Yat-sen University, Dept of Endocrinology, Guangzhou, CN, 4 Eli Lilly Asia, Inc. Shanghai, China Background and aims: Patients with higher PPBG or with carbohydrate-rich meals may benefit from insulin lispro mix 50 (LM50; 50% insulin lispro; 50% insulin lispro protamine suspension). We compared the 2-h PPBG excursion following a standard test meal in Chinese patients with Type 1 or Type 2 diabetes treated twice daily with human insulin mix 50 (HI50) versus LM50. Materials and methods: This was a multicenter, randomized, open-label, crossover study. Patients with either Type 1 or Type 2 diabetes (n=120) treated with HI50 or human insulin mix 30 twice daily, with an HbA1c between 1.1 to 1.7 times of the upper limit of the normal range, were randomized to 12 weeks of treatment with LM50 followed by 12 weeks of treatment with HI50 (before breakfast and dinner in both), or the reverse sequence. No oral anti-diabetes medicines were used within the 2 months prior to entering the study and during the treatment period. 2h-PPBG and excursion, following a standard test breakfast with 460 calories, and HbA1c value were assessed at baseline and endpoint of each treatment. Fasting blood glucose (FBG) level, insulin dose, and safety data were obtained at each visit. A crossover analysis using SAS Proc Mixed was employed to compare the two regimens. Results: One hundred and fifteen patients (57 in sequence lLM50/HI50, 58 in HI50/LM50) completed the study. Mean 2-h PPBG excursion (primary objective) decreased from 6.32±2.965 mM at baseline to 3.47±2.966 mM in the LM50 group, and from 6.32±2.965 mM to 5.02±3.324 mM in the HI50 group at endpoint of each treatment (P<0.001 in overall comparison). No significant difference was observed between treatment groups in HbA1c level (7.59% in LM50, 7.61% in HI50; P=0.581) and insulin doses (P=0.690). At endpoint, mean FBG was significantly higher with LM50 than with HI50 (9.78 mM vs 9.10 mM; P=0.023). No serious adverse events were related to the study drug; one occurred during treatment with LM50 and two with HI50. The