Clinical Experience with BIAsp 30: Results from the Philippine Cohort of the Global A1chieve Study Mary Anne Lim-Abrahan, Anand B Jain, Susan Yu-Gan, Leorino M. Sobrepena, Veronica A. RachoKey findings: Safety, effectiveness and health-related quality of life were assessed in 1,252 subjects from the Philippine cohort of the A1chieve study who were treated with the premixed insulin analogue biphasic insulin aspart 30 (BIAsp 30). This subset analysis of the study showed that administration of BIAsp 30 among Filipino patients (both insulin-naïve and prior insulin users) improved glycemic control without concomitant risk of hypoglycemia or weight gain. Other findings at the end of the study (24 weeks) include reductions in systolic blood pressure, total cholesterol, LDL cholesterol and triglycerides in the treated subjects.
Philippine Journal of Internal Medicine. 2014;52(3):1-10
Predictive and explanatory factors of change in HbA1c in a 24-week observational study of 66,726 people with type 2 diabetes starting insulin analogs PD Home, C Shen, MI Hasan, ZA Latif, JW Chen, G González GálvezKey findings: Predictor and explanatory factors of change in HbA1c were studied using data from the large observational A1chieve study. Data analyses showed that the factor explaining most of the variance in HbA1c change is baseline HbA1c level, with each increase of 1.0%-units (11 mmol/mol) providing a 0.7-0.8%-units (8-9 mmol/mol) greater fall. Other factors do not explain much of the remaining variance, even when including all end-of-trial measures.
Diabetes Care. May 2014 37;5:1237-1245
Biphasic insulin aspart 30 improved glycemic control in Chinese patients with type 2 diabetes poorly controlled on oral glucose-lowering drugs: a subgroup analysis of the A1chieve study Chen Liming, Xing Xiaoyan, Lei Minxiang, Liu Jie, Shi Yongquan, Li Pengqiu, Qin Guijun, Li Chengjiang, Li Yukun, Wang Qing, Gao Tianshu, Hu Ling, Wang Yangwei, Yang WenyingKey findings: In a subgroup analysis from the A1chieve study of 4,100 Chinese patients with type 2 diabetes who were poorly controlled on oral glucose-lowering drugs (OGLDs), treatment with biphasic insulin aspart 30 alone or in combination with OGLDs was shown to improve glycemic control with low risk of hypoglycemia.
Chinese Medical Journal. 2014;127(2):208-212
Safety, tolerability, and efficacy of insulin aspart in people with type 2 diabetes, as biphasic insulin aspart or with basal insulin: findings from the multinational, non-interventional A1chieve study Issam Hajjaji, Siddharth Shah, Yuxiu Li, Vinay Prusty, Youcef Benabbas, Philip D. HomeKey findings: In a sub-analysis of the A1chieve study, insulin-naïve and insulin-experienced people with T2DM in routine clinical care starting aspart alone at baseline and continuing aspart alone, changing to biphasic insulin aspart 30 (aspart premix) or adding a basal insulin by study end, were included. Findings of this sub-analysis were that insulin aspart therapy was well tolerated and was associated with improved glucose control over 24 weeks in people with T2DM.
Diabetes Therapy. June 2014;5(1):113-26
Type 2 diabetes mellitus management and body mass index: experiences with initiating insulin detemir in the A1chieve study Mohammed E. Khamseh, Vinay Prusty, Zafar Latif, Guillermo Gonzalez-Galvez, Guillermo Dieuzeide, Alexey ZilovKey findings: In this sub-analysis of the A1chieve study, insulin detemir therapy was associated with significant improvements in glycemic parameters, irrespective of baseline BMI status, and also induced weight loss in overweight and obese patients with T2DM. The initiation of insulin detemir therapy was well-tolerated in all patient subgroups, stratified by baseline BMI intervals, with only 4 serious adverse drug reactions reported in the entire cohort of 10,650 patients.
Diabetes Therapy. June 2014;5(1):127-40
Biphasic Insulin Aspart 30 in Insulin-Naive People with Type 2 Diabetes in Non-western Nations: Results from a Regional Comparative Multinational Observational Study (A1chieve) Siddharth Shah, Wenying Yang, Mohammad Imtiaz Hasan, Rachid Malek, Ole Molskov Bech, Philip HomeKey findings: Insulin-naïve people beginning biphasic insulin aspart 30 in routine clinical practice had clinically useful improvements in blood glucose control after 24 weeks in all seven regions represented in the A1chieve® study. However, there were interesting regional variations that are likely to be caused by regional differences in the duration of diabetes.
Diabetes Technology & Therapeutics. November 2013, 15(11): 954-963
The effectiveness and safety of beginning insulin aspart together with basal insulin in people with type 2 diabetes in non-Western nations: Results from the A1chieve observational study Philip D. Home, Zafar A. Latif, Guillermo González-Gálvez, Vinay Prusty and Zanariah Hussein.Key findings: HbA1c, FPG and PPPG improved significantly from baseline in all groups. Unsurprisingly, hypoglycaemia rates increased in those starting insulin, but decreased in the other groups. Clinically significant improvements in serum lipids and quality of life occurred across all groups.
Diabetes Research and Clinical Practice, 3, 101, pages 326 - 332
Insulin detemir in the management of type 2 diabetes in non-Western countries: Safety and effectiveness data from the A1chieve observational study Alexey Zilov, Nabil El Naggar, Siddharth Shah, Chunduo Shen and Jihad Haddad.Key findings: Starting treatment with insulin detemir resulted in significant improvements in glycaemic control with improved treatment tolerability, irrespective of prior treatment and geographical region, after 24 weeks. Mean body weight decreased overall. This paper, amongst others, presents data on patients switched from previous insulin treatments such as NPH, glargine or premix therapy.
Diabetes Research and Clinical Practice, 3, 101, pages 317 - 325
Safety and effectiveness of biphasic insulin aspart 30 in people with type 2 diabetes switching from basal-bolus insulin regimens in the A1chieve study Guillermo Dieuzeide, Lee-Ming Chuang, Abdulrahman Almaghamsi, Alexey Zilov, Jian-Wen Chen and Fernando J. Lavalle-González.Key findings: 24 weeks after switching from basal-bolus insulin regimens to biphasic insulin aspart 30, glycaemic control and health-related quality of life were significantly improved, and hypoglycaemia was significantly reduced.
Primary Care Diabetes
Safety and Effectiveness of Switching from a Basal-only to Biphasic Insulin Aspart 30 Insulin Regimen Jihad Haddad, Mohsen Khoshniatnikoo, Youcef Benabbas, Serdar Guler, Vinay Prusty, Pradana SoewondoKey findings: Changing from a basal-only to a biphasic insulin aspart 30 regimen led to statistically significant improvements in glycated haemoglobin, fasting plasma glucose,
post-prandial plasma glucose levels and in health-related quality of life.
Diabetes Therapy 2013
Safety and Effectiveness of Biphasic Insulin Aspart 30 in Different Age-Groups: A1chieve Sub-Analysis Mohammad Khamseh, Jihad Haddad, Wenying Yang, Alexey Zilov, Ole Molskov Bech, Mohammad Imtiaz HasanKey findings: Insulin-experienced and insulin-naïve adults of all age groups experienced significantly improved glycaemic control and health-related quality of life and generally a reduced incidence of hypoglycaemia with 24 weeks’ treatment with biphasic insulin aspart. Biphasic insulin aspart 30 therapy may therefore benefit adults of any age, which is particularly reassuring for elderly (>65 years) patients who face more challenges in achieving glycaemic control than younger patients.
Diabetes Therapy 2013
Safety and Effectiveness of Bolus Insulin Aspart in People with Type 2 Diabetes: A1chieve Sub-Analysis Hoosen Randeree, Andreas Liebl, Issam Hajjaji, Mohammad Khamseh, Lenita Zajdenverg, Jian-Wen Chen, Jihad HaddadKey findings: In people with type 2 diabetes and
sub-optimal glucose control, insulin aspart alone or in combination with oral glucose-lowering drugs is associated with significant improvements in glycaemic control and health-related quality of life, without an increased risk of hypoglycaemia.
Diabetes Therapy 2013, Volume 4, Pages 153–166
Safety and Effectiveness of Insulin Detemir in Different Age-Groups in the A1chieve Study Rachid Malek, Guillermo Gonzalez-Galvez, Nabil El Naggar, Siddharth Shah, Vinay Prusty, Leon LitwakKey findings: Both insulin-experienced and insulin-naïve adults had significantly improved blood glucose control and reported health-related quality of life after 24 weeks of treatment with insulin detemir, regardless of their age. Incidence of hypoglycaemia was reduced in adults of all ages except for in insulin-naïve patients aged >40–65 years, where it was unchanged, and in insulin-naïve patients aged >65 years where it was increased.
The safety and effectiveness profile of insulin detemir may therefore benefit adults of all ages.
Diabetes Therapy 2013, Volume 4, Issue 1
Switching from biphasic human insulin 30 to biphasic insulin aspart 30 in type 2 diabetes is associated with improved glycaemic control and a positive safety profile: Results from the A1chieve study Nabil K. El Naggar, Pradana Soewondo, Mohammad E. Khamseh, Jian-Wen Chen, Jihad HaddadKey findings: Switching from biphasic human insulin 30 to biphasic insulin aspart 30 in real life clinical practice was associated with significant reductions in HbA1c, FPG and PPG levels in people with poor glycaemic control. The treatment was well tolerated with reductions in the rates of both minor and major hypoglycaemia. Self-reported quality of life also improved.
Diabetes Research and Clinical Practice, 3, 98, pages 408 - 413
Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: Results from the A1chieve observational study Siddharth Shah, Alexey Zilov, Rachid Malek, Pradana Soewondo, Ole Bech, Leon LitwakKey findings: Beginning insulin analogue therapy in people with type 2 diabetes and poor blood glucose control is associated with marked improvements in diverse aspects of vascular risk factor profile, including a significant reduction in HbA1c levels without evidence of clinically significant safety or tolerability issues. In addition, patients’ reported health-related quality of life improved significantly.
Diabetes Research and Clinical Practice, Issue 3, Volume 94, pages 364 - 370
An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: The A1chieve study Philip Home, Nabil El Naggar, Mohammed Khamseh, Guillermo Gonzalez-Galvez, Chunduo Shen, Praful Chakkarwar, Yang WenyingKey findings: Beginning insulin analogue therapy in people with type 2 diabetes and poor blood glucose control is associated with marked improvements in diverse aspects of vascular risk factor profile, including a significant reduction in HbA1c levels without evidence of clinically significant safety or tolerability issues. In addition, patients’ reported health-related quality of life improved significantly.
Diabetes Research and Clinical Practice, Issue 3, Volume 94, pages 352 - 363
Observational studies: going beyond the boundaries of randomized controlled trials Wenying Yang, Alexey Zilov, Pradana Soewondo, Ole Molskov Bech, Fawzia Sekkal, Philip D. HomeKey findings: Observational trials can provide clinically relevant information that is not necessarily provided by RCTs, but given the limitations of this approach, it is important to optimise the study design to maximise their validity. In addition, known causes of bias and confounding should be measured.
Diabetes Research and Clinical Practice, Supplement 1, Volume 88, pages S3 - S9
Conducting cost-effectiveness analyses of type 2 diabetes in low- and middle-income countries: can locally generated observational study data overcome methodological limitations? SeiHyun Baik, Antônio Roberto Chacra, Li Yuxiu, Jeremy White, Serdar Güler, Zafar A. LatifKey findings: Observational data are likely to be of considerable informative value to policy makers in developing countries reaching decisions on diabetes care within an environment of scarce resources.
Diabetes Research and Clinical Practice, Supplement 1, Volume 88, pages S17 - S22
The A1chieve study: a 60 000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice Siddharth Shah, León Litwak, Jihad Haddad, Praful Chakkarwar, Issam HajjajiKey findings: The A1chieve® study will evaluate adverse events and effectiveness of premix (biphasic insulin aspart 30 [NovoMix® 30]), basal (insulin detemir [Levemir®]), and
meal-time (insulin aspart [NovoRapid®]) insulin analogues in people with type 2 diabetes in near-routine clinical practice and should provide important information about how insulin analogues perform in an everyday clinical setting.
Diabetes Research and Clinical Practice, Supplement 1, Volume 88, pages S11 - S16