PURPOSE: With a duration of action of approximately 24 hours and peakless levels, Lantus is a more physiologic basal insulin analogue compared with NPH. The aim of this study was to compare the glycemic control of Lantus plus Humalog with that of premixed insulin in children and adolescents with type 1 diabetes mellitus. METHODS: The subjects consisted of 25 patients with type 1 diabetes mellitus, aged 12-19 years, who changed their insulin regimen from premixed insulin to Lantus plus Humalog. Daily insulin doses, frequency of hypoglycemia, fasting blood glucose, C-peptide concentration and HbA1c before and 6 months after Lantus treatment were compared. 24 hour blood glucose of 11 patients among Lantus treatment group (n=25) and premixed insulin treatment group (n=10) were self-monitored and compared. RESULTS: 6 months after Lantus treatment, the episodes of hypoglycemia were reduced by 50%(15.1 vs. 7.6 events/month), especially nocturnal hypoglycemia by 67%(6.7 vs. 2.5 events/month). HbA1c was reduced from 9.3% to 8.7% after Lantus treatment. Self-monitored blood glucose of Lantus treatment group at postbreakfast 30, 60, 90 and 120 minutes were 171.1, 169.5, 171.0 and 154.1 mg/dL respectively and lower than those of premixed insulin treatment group (259.7, 282.7, 280.0 and 250.9 mg/dL respectively). CONCLUSION: Compared with premixed insulin, Lantus plus Humalog is more effective in glycemic control and reduction in nocturnal hypoglycemia in children and adolescents with type 1 diabetes mellitus.
Adolescent* ; Blood Glucose ; C-Peptide ; Child* ; Diabetes Mellitus, Type 1* ; Humans ; Hypoglycemia ; Insulin ; Insulin Glargine ; Skin

Insulin plays an important role in the treatment of diabetes. Since it was discovered in the early 1920s, major advances have been made in the medical use of insulin. However, certain insulin associated challenges remain, such as hypoglycemia, weight gain, complex management, and injection site pain. Novel insulins and delivery systems are being developed that can address these limitations. Insulin degludec is a novel basal insulin with a long half-life (25 hours) and action duration (> 42 hours). Glargine U300 is a concentrated formulation of insulin glargine. For improvement in postprandial glucose control, ultrarapid-acting insulins are being investigated. New insulin delivery systems including inhaled insulin and insulin patches are also being developed to overcome the inconvenience associated with subcutaneous injection. In this review, clinical studies of new insulins and new insulin delivery systems are summarized.
Diabetes Mellitus ; Glucose ; Half-Life ; Hypoglycemia ; Injections, Subcutaneous ; Insulin* ; Insulins* ; Weight Gain ; 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

BACKGROUND: The aim of this study was to evaluate the safety and effectiveness of insulin glargine in a large population from a variety of clinical care in Iranian people with type 2 diabetes mellitus (T2DM) and to measure the percentage of patients achieving glycosylated hemoglobin (HbA1c) <7% by the end of 24 weeks of treatment in routine clinical practice. METHODS: This study was a 24 week, observational study of patients with T2DM, for whom the physician had decided to initiate or to switch to insulin glargine. The safety and efficacy of glargine were assessed at baseline and at week 24. RESULTS: Seven hundred and twenty-five people with T2DM (63% female) including both insulin naïve and prior insulin users were recruited in this study. The mean age of the participants was 54.2±11.2 years, and the mean HbA1c level was 8.88%±0.93% at baseline. By the end of the study, 27% of the entire participants reached to HbA1c target of less than 7% and 52% had HbA1c ≤7.5%. No serious adverse event was reported in this study. Furthermore, overall hypoglycemia did not increase in prior insulin users and the entire cohort. In addition, body weight did not change in participants while lipid profile improved significantly. CONCLUSION: Treatment with insulin glargine could improve glycemic control without increasing the risk of hypoglycemic events in people with T2DM. In addition, a significant clinical improvement was observed in lipid profile.
Body Weight ; Cohort Studies ; Consensus* ; Diabetes Mellitus, Type 2* ; Hemoglobin A, Glycosylated ; Humans ; Hypoglycemia ; Insulin Glargine ; Insulin* ; Observational Study

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

BACKGROUND: The prevalence of type 2 diabetes mellitus (T2DM) and obesity is increasing in Korea. Clinical studies in patients with T2DM have shown that combining the glucagon-like peptide-1 receptor agonist exenatide twice daily with basal insulin is an effective glucose-lowering strategy. However, these studies were predominantly conducted in non-Asian populations. METHODS: We conducted a subgroup analysis of data from a multinational, 30-week, randomized, open-label trial to compare the effects of exenatide twice daily (n=10) or three times daily mealtime insulin lispro (n=13) among Korean patients with T2DM inadequately controlled (glycosylated hemoglobin [HbA1c] >7.0%) on metformin plus optimized insulin glargine. RESULTS: Exenatide twice daily and insulin lispro both reduced HbA1c (mean −1.5% and −1.0%, respectively; P<0.01 vs. baseline). Fasting glucose and weight numerically decreased with exenatide twice daily (−0.7 mmol/L and −0.7 kg, respectively) and numerically increased with insulin lispro (0.9 mmol/L and 1.0 kg, respectively). Minor hypoglycemia occurred in four patients receiving exenatide twice daily and three patients receiving insulin lispro. Gastrointestinal adverse events were the most common with exenatide twice daily treatment. CONCLUSION: This analysis found treatment with exenatide twice daily improved glycemic control without weight gain in Korean patients with T2DM unable to achieve glycemic control on metformin plus basal insulin.
Diabetes Mellitus, Type 2* ; Fasting ; Glucagon-Like Peptide-1 Receptor ; Glucose ; Humans ; Hypoglycemia ; Insulin Glargine ; Insulin Lispro* ; Insulin* ; Korea ; Meals ; Metformin ; Obesity ; Prevalence ; Weight Gain

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

BACKGROUND: Many Muslim type 2 diabetes mellitus (T2DM) patients choose to fast the month of Ramadan despite the possible adverse health effects brought about by the change in dietary habits, among other things. Clinical data regarding the safety of multi-drug regimens during fasting are particularly scarce. The aim of the study was to evaluate the safety of a drug protocol devised by the authors to accommodate Ramadan's dietary changes, involving dose adjustments of four anti-diabetic drug regimens in T2DM patients fasting Ramadan. METHODS: In this prospective, observational, open-label study, 301 T2DM patients who wished to fast Ramadan were followed during Ramadan and the preceding month. The incidence of hypoglycemia, diabetic ketoacidosis (DKA) and non-ketotic hyperosmolar state (NKHS) was monitored. Patients were classified into four groups: A group (those taking metformin, sulfonylurea and insulin [n=33]); B group (metformin and sulfonylurea [n=89]); C group (metformin and insulin [n=96]); and D group (premixed 70/30, glargine or regular insulin [n=82]). During Ramadan, drug doses were adjusted as percentages of their pre-Ramadan values: 75% for sulfonylureas, 75% for glargine, 75% for premixed insulin 70/30 in two doses, and 75% for regular insulin. Metformin was adjusted to a twice-daily regimen. RESULTS: No cases of DKA or NKHS were reported. Hypoglycemia occurred at a lower rate than pre-Ramadan values in groups C, and D; and a similar rate in groups A, and B. CONCLUSION: The data suggested that using the above protocol to adjust the doses of anti-diabetic drugs is safe in T2DM patients in regards to hypoglycemia, DKA, and NKHS.
Diabetes Mellitus, Type 2 ; Diabetic Ketoacidosis ; Fasting* ; Food Habits ; Humans ; Hypoglycemia ; Incidence ; Insulin ; Insulin Glargine ; Islam ; Metformin ; Observational Study* ; Prospective Studies

BACKGROUND: We aimed to investigate the effectiveness and safety of adding basal insulin to initiating dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin and/or sulfonylurea (SU) in achieving the target glycosylated hemoglobin (HbA1c) in patients with type 2 diabetes mellitus (T2DM). METHODS: This was a single-arm, multicenter, 24-week, open-label, phase 4 study in patients with inadequately controlled (HbA1c ≥7.5%) T2DM despite the use of DPP-4 inhibitor and metformin. A total of 108 patients received insulin glargine while continuing oral antidiabetic drugs (OADs). The primary efficacy endpoint was the percentage of subjects achieving HbA1c ≤7.0%. Other glycemic profiles were also evaluated, and the safety endpoints were adverse events (AEs) and hypoglycemia. RESULTS: The median HbA1c at baseline (8.9%; range, 7.5% to 11.1%) decreased to 7.6% (5.5% to 11.7%) at 24 weeks. Overall, 31.7% subjects (n=33) achieved the target HbA1c level of ≤7.0%. The mean differences in body weight and fasting plasma glucose were 1.2±3.4 kg and 56.0±49.8 mg/dL, respectively. Hypoglycemia was reported in 36 subjects (33.3%, 112 episodes), all of which were fully recovered. There was no serious AE attributed to insulin glargine. Body weight change was significantly different between SU users and nonusers (1.5±2.5 kg vs. −0.9±6.0 kg, P=0.011). CONCLUSION: The combination add-on therapy of insulin glargine, on metformin and DPP-4 inhibitors with or without SU was safe and efficient in reducing HbA1c levels and thus, is a preferable option in managing T2DM patients exhibiting dysglycemia despite the use of OADs.
Blood Glucose ; Body Weight ; Body Weight Changes ; Diabetes Mellitus, Type 2 ; Fasting ; Hemoglobin A, Glycosylated ; Humans ; Hypoglycemia ; Hypoglycemic Agents ; Insulin Glargine ; Insulin ; Metformin ; Morinda

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