BACKGROUND: A1chieve(R) was a noninterventional study evaluating the clinical safety and efficacy of biphasic insulin aspart 30, insulin detemir, and insulin aspart. METHODS: Korean type 2 diabetes patients who have not been treated with the study insulin or have started it within 4 weeks before enrollment were eligible for the study. The patient selection and the choice of regimen were at the discretion of the physician. The safety and efficacy information was collected from the subjects at baseline, week 12, and week 24. The number of serious adverse drug reactions (SADRs) was the primary endpoint. The changes of clinical diabetic markers at week 12 and/or at week 24 compared to baseline were the secondary endpoints. RESULTS: Out of 4,058 exposed patients, 3,003 completed the study. During the study period, three SADRs were reported in three patients (0.1%). No major hypoglycemic episodes were observed and the rate of minor hypoglycemic episodes marginally decreased during 24 weeks (from 2.77 to 2.42 events per patient-year). The overall quality of life score improved (from 66.7+/-15.9 to 72.5+/-13.5) while the mean body weight was slightly increased (0.6+/-3.0 kg). The 24-week reductions in glycated hemoglobin, fasting plasma glucose and postprandial plasma glucose were 1.6%+/-2.2%, 2.5+/-4.7 mmol/L, and 4.0+/-6.4 mmol/L, respectively. CONCLUSION: The studied regimens showed improvements in glycemic control with low incidence of SADRs, including no incidence of major hypoglycemic episodes in Korean patients with type 2 diabetes.
Biphasic Insulins ; Body Weight ; Diabetes Mellitus, Type 2 ; Drug Toxicity ; Fasting ; Glucose ; Hemoglobins ; Humans ; Incidence ; Insulin ; Insulin Aspart ; Insulin, Isophane ; Insulin, Long-Acting ; Patient Selection ; Plasma ; Quality of Life ; Republic of Korea ; Treatment Outcome ; Insulin Detemir

Allergic reaction to insulin is mediated by several mechanisms; differences in amino acid sequence of animal and human insulin, altered tertiary structure of insulin and the presence of non-insulin protein contaminants or pharmaceutical additives. Anaphylactic reactions to insulin only occur in 0.1 to 2% of patients who stopped insulin therapy and have then resumed treatment. We report a diabetic patient who suffered severe anaphylactic reactions to human recombinant insulin, successfully treated by desensitization. A 19-year-old man with type 1 diabetes receiving Insulatard HM(R) developed generalized urticaria and angioedema with progression to dyspnea, dizziness and syncope. Skin prick test to all kinds of human recombinant insulin products revealed immediate type hypersensitivity and the titer of insulin IgE was increased in serum. The desensitization trial with Velosulin HM(R) using modified desensitization method was performed. Six months after the desensitization he was taking Velosulin HM(R) as well as Insulatard HM(R) without any evidence of systemic allergic reactions.
Amino Acid Sequence ; Anaphylaxis* ; Angioedema ; Animals ; Dizziness ; Dyspnea ; Humans* ; Hypersensitivity ; Immunoglobulin E ; Insulin* ; Insulin, Regular, Pork ; Skin ; Syncope ; Urticaria ; Young Adult ; Isophane Insulin, Human

Biphasic Insulins ; Diabetes Mellitus, Type 2 ; drug therapy ; Female ; Humans ; Hypoglycemic Agents ; administration & dosage ; Insulin ; administration & dosage ; analogs & derivatives ; Insulin Aspart ; Insulin, Isophane ; Male ; Middle Aged ; Treatment Outcome

BACKGROUND: The purpose of this study was to evaluate change in glycosylated hemoglobin (HbA1c), side effects, and quality of life (QOL) after a 16-week treatment period with Biphasic insulin aspart 30/70 (BIasp30) in patients with type 2 diabetes mellitus (T2DM) who had been suboptimally controlled with oral antidiabetic drugs (OADs). METHODS: The study consisted of a 4-week titration period when concurrent OAD(s) were replaced with BIasp30 and followed by a 12-week maintenance period. All patients completed the Diabetes Treatment Satisfaction Questionnaire at the beginning and the end of the trial. Hypoglycemic episodes were recorded by the patient throughout the trial. RESULTS: Sixty patients were included, of whom 55 patients (92%) completed the full 16-week treatment period. Seven-point blood glucose was significantly improved as compared with the baseline, except for the postlunch blood glucose level. HbA1c at the end of period was significantly improved from 9.2% to 8.2% (P<0.001). Eleven percent (n=6) of patients achieved HbA1c values < or =6.5% and 22% (n=12) of patients achieved <7.0%. There were 3.4 episodes/patients-year of minor hypoglycemia and 0.05 episodes/patients-year of major hypoglycemia. QOL showed significant changes only in the acceptability of high blood glucose category (P=0.003). CONCLUSION: Treatment with once or twice daily BIasp30 may be an option for the patients with T2DM suboptimally controlled with OADs in Korea. However, considering the low number of patients achieving the HbA1c target and the high postlunch blood glucose levels, additional management with another modality may be required for optimal control.
Biphasic Insulins ; Blood Glucose ; Diabetes Mellitus, Type 2 ; Hemoglobin A, Glycosylated ; Humans ; Hypoglycemia ; Hypoglycemic Agents ; Insulin Aspart ; Insulin, Isophane ; Korea ; Quality of Life

BACKGROUNDThe clinical importance of glycaemic control in patients with diabetes has been well established. This study aimed to explore twice-daily biphasic insulin aspart 30 (BIAsp 30) for insulin initiation in patients with type 2 diabetes mellitus (T2DM) who had poor glycaemic control with human insulins (HIs). We use data from a Chinese cohort of the PRESENT study.

METHODSIn the 3-month study, Chinese subjects with T2DM started insulin therapy with BIAsp 30 in routine care. Glycaemic control was measured by glycosylated hemoglobin (HbA(1C)), fasting plasma glucose (FPG) and posting plasma glucose (PPG). The safety assessment included hypoglycaemia and other adverse events.

RESULTSA total of 1989 subjects previously treated with His were switched to BIAsp 30 for 3-month treatment. Mean HbA(1C), FPG and PPG were significantly improved after the therapy. The overall rate of hypoglycaemia decreased at the end of the trial except for the patients previously treated with long-acting insulin. Most of the events were minor and diurnal hypoglycaemia. Only one serious adverse drug reaction (SADR), a local hypersensitivity, was reported. The majority of the patients (> or = 96.7%) and physicians (> or = 84.7%) were either satisfied or very satisfied with the treatment using BIAsp 30 compared with previous HI therapy.

CONCLUSIONThe BIAsp 30 treatment improved both glycaemic control and patients' satisfaction without increasing hypoglycaemia in T2DM subjects inadequately controlled by His.

Adult ; Biphasic Insulins ; Diabetes Mellitus, Type 2 ; drug therapy ; metabolism ; Female ; Glycated Hemoglobin A ; drug effects ; Humans ; Insulin ; administration & dosage ; adverse effects ; analogs & derivatives ; pharmacology ; therapeutic use ; Insulin Aspart ; Insulin, Isophane ; Male ; Middle Aged ; Prospective Studies ; Treatment Outcome

BACKGROUNDThe effectiveness and safety of initiating biphasic insulin aspart 30 in patients who were poorly controlled on oral glucose-lowering drugs were studied in randomized controlled trials, while results from clinical practice remain limited. This subgroup analysis was to provide such findings from a large-scale non-interventional study.

METHODSA1chieve was a multinational, prospective, open-label, non-interventional, 24-week study in patients with type 2 diabetes initiating insulin analogues in 28 countries across Asia, Africa, Europe, and Latin America. After physician had taken the decision to use this insulin, any patient with type 2 diabetes who was not treated with or who had started the study insulin within 4 weeks before inclusion was eligible. Patients were treated with study insulin alone or in combination with oral glucose-lowering drugs. Data on adverse drug reactions, hypoglycemia and glycemic control were collected at baseline, week 12 and 24. This is a report of a Chinese subgroup analysis from the A1chieve study.

RESULTSTotally, 4 100 patients constituted this subgroup. No serious adverse drug reactions were reported. Rates of total, major, nocturnal hypoglycemic events (events/patient per year) were 1.47, 0.10, 0.31 at baseline and 1.35, 0.00, 0.22 at week 24, respectively. Glycemic control was improved as measured by hemoglobin A1c (mean 9.3% to 7.0%, reduction -2.3%), fasting plasma glucose (mean 10.2 to 6.8 mmol/L, reduction -3.5 mmol/L) and postprandial plasma glucose (mean 14.4 to 8.8 mmol/L, reduction -5.6 mmol/L), all P < 0.001. Change in mean body weight was +0.3 kg (P < 0.001).

CONCLUSIONIn this subgroup analysis of the A1chieve study, biphasic insulin aspart 30 improved glycemic control with low risk of hypoglycemia.

Administration, Oral ; Adult ; Aged ; Biphasic Insulins ; administration & dosage ; adverse effects ; therapeutic use ; Blood Glucose ; drug effects ; Diabetes Mellitus, Type 2 ; blood ; drug therapy ; Female ; Glycated Hemoglobin A ; metabolism ; Humans ; Hypoglycemic Agents ; therapeutic use ; Insulin Aspart ; administration & dosage ; adverse effects ; therapeutic use ; Insulin, Isophane ; administration & dosage ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Prospective Studies

BACKGROUND: The initial insulin dose is often determined by clinical experience or with a formula using the body weight. However, it may be difficult to determine the initial insulin dose because various factors such as insulin sensitivity and the glycemic status can influence the insulin requirement. The purpose of this study was to assess the factors that influence the initial insulin requirement in insulin naive patients with type 2 diabetes mellitus. METHODS: A total 128 patients who were admitted for glycemic control were investigated. The patients were managed with long-acting insulin glargine and rapid-acting insulin lispro. RESULTS: The basal insulin requirement was positively correlated with waist circumference, body mass index (BMI), the HbA1C, AST, ALT, fasting plasma glucose and 2-hour postprandial glucose levels and the homeostasis model assessment of insulin resistance (HOMA-IR), but it was negatively correlated with age and the stimulated C-peptide level. The daily insulin requirement was positively correlated with waist circumference, BMI, the HbA1C, AST, ALT, triglyceride, fasting plasma glucose and 2-hour postprandial glucose level and HOMA-IR, but it was negatively correlated with age. On the multiple linear regression analysis, the basal insulin requirement was independently associated with BMI (beta = 0.507, p < 0.001), the 2-hour postprandial glucose level (beta = 0.307, p < 0.001), the ALT level (beta = 0.214, P = 0.015) and the meal-stimulated C-peptide level (beta = -0.209, P = 0.010). The daily insulin requirement was independently associated with BMI (beta = 0.508, p < 0.001) and the 2-hour postprandial glucose level (beta = 0.404, p < 0.001). CONCLUSION: Our results show that the BMI and 2-hour postprandial glucose level are useful predictors of the initial insulin requirement in insulin naive type 2 diabetic patients. It may be prudent to consider the other various factors that influence the insulin requirement together when insulin therapy is required.
Body Mass Index ; Body Weight ; C-Peptide ; Diabetes Mellitus ; Diabetes Mellitus, Type 2 ; Fasting ; Glucose ; Homeostasis ; Humans ; Insulin ; Insulin Lispro ; Insulin Resistance ; Insulin, Long-Acting ; Insulin, Short-Acting ; Linear Models ; Plasma ; Waist Circumference ; Insulin Glargine

OBJECTIVE: To evaluate the safety, effectiveness and health-related quality of life (HRQoL) parameters of A1chieve study participants in the Philippine cohort, who were treated with BIAsp 30.
METHODOLOGY: A1chieve is a non-interventional, six-month, observational study of 66,726 people with type 2 diabetes mellitus (T2DM), including both insulin users and non-insulin users, started on insulin detemir, insulin aspart, or BIAsp 30 in 28 countries across four continents. The present study evaluates the safety, effectiveness and HRQoL in 1,252 subjects from the Philippine cohort of the A1chieve study who were treated with BIAsp 30.
RESULTS: At baseline, the mean age, duration of diabetes and mean BMI were found to be 55.5±11.7 years, 7.2 ± 5.6 years and 25.4 ± 5.3 kg/m2, respectively. Seventy-eight percent (78%) of subjects were insulin naïve and 22% were prior insulin users. At baseline, glycemic control was poor (HbA1c = 9.9%) in the entire cohort. Overall there was a 2.7% reduction in mean HbA1c and 44.2% subjects achieved the HbA1c target of <7.0%, after 24 weeks of therapy with BIAsp 30. There were significant reductions in total cholesterol, LDL-cholesterol, triglycerides and systolic blood pressure after 24 weeks of therapy with BIAsp 30. There was no increase in the incidence of hypoglycemia among insulin-naïve subjects, while there was a marked reduction in hypoglycemia (4.93 to 2.53 events/person-year) among prior insulin users at 24 weeks.
CONCLUSION: BIAsp 30 is safe and efficacious for initiating and intensifying insulin therapy for Filipino T2DM patients.

Human ; Male ; Female ; Middle Aged ; Adult ; Insulin Aspart ; Insulin ; Diabetes Mellitus, Type 2 ; Hemoglobin A, Glycosylated ; Cholesterol, Ldl ; Triglycerides ; Insulin, Isophane

No abstract available.
Biphasic Insulins

No abstract available.
Biphasic Insulins