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

BACKGROUND: The present study investigates the efficacy in glycemic control by adding once-a-day glulisine to glargine as a basal plus regimen and factors influencing glycemic control with the basal plus regimen in Korean subjects with type 2 diabetes. METHODS: In the present retrospective study, subjects previously treated with the basal plus regimens for at least 6 months were reviewed. Changes in glycemic profiles and clinical parameters were evaluated. RESULTS: A total of 87 subjects were ultimately enrolled in this study. At baseline, mean glycated hemoglobin (A1c) and glycated albumin were 8.5% (8.0% to 9.6%) and 25.2+/-7.6%, respectively. After treatment with the basal plus regimen, patients had significant reductions of A1c at 6 months (0.8+/-0.1%, P<0.001) and their postprandial glucose levels were decreased by 48.7+/-10.3 mg/dL (P<0.001). Multiple logistic regression showed old age (odds ratio [OR], 1.25; 95% confidence interval [CI], 1.02 to 1.55), high initial A1c (OR, 22.21; 95% CI, 2.44 to 201.78), and lower amounts of glargine (OR, 0.85; 95% CI, 0.76 to 0.99), and glimepiride (OR, 0.23; 95% CI, 0.06 to 0.93) at baseline were independently associated with good responders whose A1c reduction was more than 0.5%. CONCLUSION: The authors suggest a basal plus regimen may be effective in reducing glucose levels of subjects with old age, high initial A1c, and patients on low doses of glimepiride and glargine. Despite the use of high doses of hypoglycemic agents, elderly patients with poorly-controlled diabetes are preferred for early initiation of the basal plus regimen.
Aged ; Diabetes Mellitus, Type 2 ; Glucose ; Hemoglobins ; Humans ; Hypoglycemic Agents ; Insulin ; Insulin, Long-Acting ; Insulin, Short-Acting ; Logistic Models ; Retrospective Studies ; Serum Albumin ; Sulfonylurea Compounds ; Insulin Glargine

Day-to-day insulin requirements often change due to subtle variations in insulin metabolism in patients with type 2 diabetes undergoing hemodialysis. In such cases, intra-hemodialysis hypoglycemia frequently occurs and is a main factor interfering with the delivery of dialysis. As a result, it reduces the quality of life in patients undergoing hemodialysis. The long-acting insulin analogue glargine provides peakless, continuous release over 24 h that approximates a normal basal insulin pattern. Because it has no peak, its use in patients with diabetes undergoing hemodialysis would hypothetically be useful. Specifically, patients would be able to avoid intra-hemodialysis hypoglycemia without the necessity of skipping insulin administration on the day of hemodialysis and achieving adequate glucose control on other days. We recently experienced six cases that switched from treatment with intermediate-acting insulin to a long-acting insulin analogue, which provided better glycemic control by reducing hypoglycemia risk. Limited data are available in the literature concerning insulin analogue usage in patients with diabetes undergoing hemodialysis. Our experience suggests a large-scale prospective investigation is required on this issue.
Dialysis ; Glucose ; Humans ; Hypoglycemia ; Insulin ; Insulin, Long-Acting ; Kidney Failure, Chronic ; Quality of Life ; Renal Dialysis ; Insulin Glargine

This is a work aimed to investigate the efficacy and safety of the combination of metformin with glargine or with neutral protamine Hagedorn in treatment of type 2 diabetes mellitus. Sixty such patients with poor glycemic control by oral antidiabetic drugs were included and divided into group A and group B. Thirty patients in group A were treated with glargine and metformin, and the other 30 patients in group B were treated with neutral protamine Hagedorn and metformin for 12 weeks. Fasting plasma glucose (FPG), postprandial glucose(PPG) and HbA1c were measured before and after the treatment. Hypoglycemia was also noted. At the end of the study, the levels of FPG, PPG and HbAlc were significantly lower than the baseline levels in the two groups (P < 0.05). At the 12th week, the percentage of HbAlc < 7% in group A was 53.3% and that in group B was 40.0%; statistically, there was no significant difference (P > 0.05). After the end of the treatment, there was no significant difference in that the percentage of HbA1c < 7% was 70.6% in group A and 62.5% in group B; the two groups' HbA1c levels were > or = 7%-9% at the baseline (P > 0.05). No sigificant difference in respect to the incidence rate of hypoglycemia in the two groups was noted (P > 0.05). In the cases of type 2 diabetes mellitus with poor glycaemic control by oral antidiabetic drug, glucose and HbA1c can be lowered further by the combination of metformin with glargine or with neutral protamine Hagedorn, the incidence rate of hypoglycemia is low. Metformin plus glargine or plus neutral protamine Hagedorn is a safe and effective therapeutic choice for type 2 diabetes mellitus cases with poor glycaemic control; moreover, metformin plus neutral protamine is a cheaper and effective choice.
Aged ; Diabetes Mellitus, Type 2 ; drug therapy ; Drug Therapy, Combination ; Female ; Humans ; Hypoglycemic Agents ; administration & dosage ; adverse effects ; Insulin Glargine ; Insulin, Isophane ; administration & dosage ; adverse effects ; Insulin, Long-Acting ; administration & dosage ; adverse effects ; Male ; Metformin ; administration & dosage ; adverse effects ; Middle Aged

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

OBJECTIVETo investigate the feasibility of perioperative glycemic control with insulin glargine in type 2 diabetic patients.

METHODSWe retrospectively analyzed the clinical data of 16 type 2 diabetic inpatients treated with insulin glargine (research group) and 16 type 2 diabetic inpatients treated with the traditional intensified insulin therapy (control group) for perioperative glycemic control.

RESULTSThe fasting blood glucose values of the diabetic patients in the research group on the day of surgery and the first 3 postoperative days were (7.5 +/- 1.8), (8.2 +/- 1.8), (7.6 +/- 1.6), and (7.2 +/- 1.1) mmol/L, respectively, and were (9.0 +/- 2.8), (10.4 +/- 2.4), (8.8 +/- 2.7), (9.0 +/- 2.0) mmol/L in the control group, respectively. The fasting blood glucose values in the research group were significantly lower than the control group on the first and third postoperative day (P = 0.02 and 0.01, respectively). No hypoglycemic events were observed and all wounds were healed well in both groups.

CONCLUSIONWith satisfied fasting blood glucose level and fewer episode of hypoglycemia, perioperative glycemic control by insulin glargine in type 2 diabetic patients is safe, effective, and convenient.

Blood Glucose ; analysis ; Diabetes Mellitus, Type 2 ; blood ; drug therapy ; Humans ; Hypoglycemic Agents ; adverse effects ; therapeutic use ; Insulin ; adverse effects ; analogs & derivatives ; therapeutic use ; Insulin Glargine ; Insulin, Long-Acting ; Perioperative Care ; Retrospective Studies

OBJECTIVETo evaluate the efficacy and safety of two insulin treatment protocols using a continuous glucose monitoring system.

METHODSType 2 diabetic patients mellitus with unsatisfactory control of fasting blood glucose by oral antidiabetic drugs were included in the study. The patients were randomized into two groups to receive bedtime injection of glargine and oral antidiabetic drugs (group A) or injection of Novolin 30 R twice a day (group B) for 12 weeks. The insuline dose was adjusted according to fasting blood glucose till discharge. Continuous glucose monitoring system was used to record the average blood glucose, fasting blood glucose, 2 h postprandial blood glucose, AUCPG ≥ 10.0 mmol/L%, HbA1c and C peptide, bedtime blood glucose, 3:00 AM blood glucose, the incidence of hypoglycemia and body mass index.

RESULTSThe average blood glucose, fasting blood glucose, 2 h postprandial blood glucose, AUCPG ≥ 10.0 mmol/L% and HbA1c was significantly decreased and C peptide significantly increased in the two groups after the treatments. The patients in glargine group showed better improvement with a significantly lower incidence of hypoglycemia than those in Novolin 30 R group. BMI underwent no significant changes in the two groups after the treatments.

CONCLUSIONGlargine therapy better mimics the physiological insulin secretion patterns, and when combined with oral antidiabetic drugs, can be more effective and safer than premixed insulin.

Adult ; Aged ; Blood Glucose ; analysis ; Blood Glucose Self-Monitoring ; methods ; Computer Systems ; Diabetes Mellitus, Type 2 ; drug therapy ; Female ; Glycated Hemoglobin A ; analysis ; Humans ; Hypoglycemic Agents ; administration & dosage ; Insulin ; administration & dosage ; Insulin Glargine ; Insulin, Long-Acting ; administration & dosage ; Male ; Middle Aged ; Monitoring, Ambulatory

BACKGROUNDIncreased risk of bladder cancer has been reported in diabetic patients. This study was to investigate the roles of mitogen-activated protein kinase kinase (MEK) 1 and 2 in the regulation of human insulin- and insulin glargine-induced proliferation of human bladder cancer T24 cells.

METHODSIn the absence or presence of a selective inhibitor for MEK1 (PD98059) or a specific siRNA for MEK2 (siMEK2), with or without addition of insulin or glargine, T24 cell proliferation was evaluated by cell counting kit (CCK)-8 assay. Protein expression of MEK2, phosphorylation of ERK1/2 and Akt was analyzed by Western blotting.

RESULTST24 cell proliferation was promoted by PD98059 at 5 - 20 µmol/L, inhibited by siMEK2 at 25 - 100 nmol/L. PD98059 and siMEK2 remarkably reduced phosphorylated ERK1/2. Insulin- and glargine-induced T24 cell proliferation was enhanced by PD98059, suppressed while not blocked by siMEK2. Insulin- and glargine-induced ERK1/2 activation was blocked by PD98059 or siMEK2 treatment, whereas activation of Akt was not affected.

CONCLUSIONMEK1 inhibits while MEK2 contributes to normal and human insulin- and insulin glargine-induced human bladder cancer T24 cell proliferation.

Blotting, Western ; Cell Line, Tumor ; Cell Proliferation ; drug effects ; Flavonoids ; pharmacology ; Humans ; Insulin ; pharmacology ; Insulin Glargine ; Insulin, Long-Acting ; pharmacology ; MAP Kinase Kinase 1 ; antagonists & inhibitors ; metabolism ; MAP Kinase Kinase 2 ; genetics ; metabolism ; MAP Kinase Signaling System ; drug effects ; genetics ; Phosphorylation ; drug effects ; RNA, Small Interfering ; genetics ; physiology ; Urinary Bladder Neoplasms ; metabolism

BACKGROUND: This is part of a prospective study carried out as a national project to secure standardized public resources for type 2 diabetes mellitus (T2DM) patients in Korea. We compared various characteristics of long-standing T2DM patients with diabetic retinopathy (DR) and macular edema (ME). METHODS: From September 2014 to July 2015, T2DM patients with disease duration of at least 15 years were recruited at a single university hospital. Clinical data and samples were collected according to the common data elements and standards of procedure developed by the Korean Diabetes Association Research Council. Each participant was assessed by ophthalmologists for DR and ME. RESULTS: Among 220 registered patients, 183 completed the ophthalmologic assessment. DR was associated with longer disease duration (odds ratio [OR], 1.071; 95% confidence interval [CI], 1.001 to 1.147 for non-proliferative diabetic retinopathy [NPDR]) (OR, 1.142; 95% CI, 1.051 to 1.242 for proliferative diabetic retinopathy [PDR]) and the use of long-acting insulin (OR, 4.559; 95% CI, 1.672 to 12.427 for NPDR) (OR, 4.783; 95% CI, 1.581 to 14.474 for PDR), but a lower prevalence of a family history of cancer (OR, 0.310; 95% CI, 0.119 to 0.809 for NPDR) (OR, 0.206; 95% CI, 0.063 to 0.673 for PDR). ME was associated with higher glycosylated hemoglobin levels (OR, 1.380; 95% CI, 1.032 to 1.845) and the use of rapid-acting insulin (OR, 5.211; 95% CI, 1.445 to 18.794). CONCLUSION: Various clinical features were associated with DR and ME. Additional epidemiological and biorepository-based studies using this cohort are being conducted to deepen our understanding of diabetic complications in Korea.
Cohort Studies ; Common Data Elements ; Diabetes Complications ; Diabetes Mellitus, Type 2* ; Diabetic Retinopathy* ; Hemoglobin A, Glycosylated ; Humans ; Insulin, Long-Acting ; Insulin, Short-Acting ; Korea ; Macular Edema ; Prevalence ; Prospective Studies

Allergic reaction to human insulin is uncommon. But they can cause mild to severe symptoms such as dyspnea, hypotensive shock, etc. Here we report the case of a patient with type 2 diabetes and insulin allergy successfully managed with desensitization. A 60-year-old man with insulin allergy was transferred. He had poorly controlled type 2 diabetes (fasting blood glucose 230 mg/dL). He developed itching sense and erythema at the injection sites of human insulin in a few minutes. And serum IgE level was elevated to 1618.0 IU/mL. The insulin was changed to other preparations, including short and long-acting insulin analogues, with similar responses. He was commenced on twice a day injection protocol in addition to his oral hypoglycemic agents, and achieved fair control (fasting blood glucose 100 mg/dL) on 24 units of Novomix Flex Pen per day, with little or no skin or systemic reaction. This is the case report of insulin allergy in type 2 diabetes being successfully managed by desensitization.
Blood Glucose ; Dyspnea ; Erythema ; Humans ; Hypersensitivity ; Hypoglycemic Agents ; Immunoglobulin E ; Insulin ; Insulin, Long-Acting ; Middle Aged ; Pruritus ; Shock ; Skin