Rapid-acting Insulin Analogues Research Articles

Treating Type 1 Diabetes Mellitus with a Rapid-Acting Analog Insulin Regimen vs. Regular Human Insulin in Germany: A Long-Term Cost-Effectiveness Evaluation.

The aim of the present study was to evaluate the cost effectiveness of rapid-acting analog insulin relative to regular human insulin in adults with type 1 diabetes mellitus in Germany. The PRIME Diabetes Model, a patient-level, discrete event simulation model, was used to project long-term clinical and cost outcomes for patients with type 1 diabetes from the perspective of a German healthcare payer. Simulated patients had a mean age of 21.5years, duration of diabetes of 8.6years, and baseline glycosylated hemoglobin of 7.39%. Regular human insulin and rapid-acting analog insulin regimens reduced glycosylated hemoglobin by 0.312 and 0.402%, respectively. Compared with human insulin, hypoglycemia rate ratios with rapid-acting analog insulin were 0.51 (non-severe nocturnal) and 0.80 (severe). No differences in non-severe diurnal hypoglycemia were modeled. Discount rates of 3% were applied to future costs and clinical benefits accrued over the 50-year time horizon. In the base-case analysis, rapid-acting analog insulin was associated with an improvement in quality-adjusted life expectancy of 1.01 quality-adjusted life-years per patient (12.54 vs. 11.53 quality-adjusted life-years). Rapid-acting analog insulin was also associated with an increase in direct costs of €4490, resulting in an incremental cost-effectiveness ratio of €4427 per quality-adjusted life-year gained vs. human insulin. Sensitivity analyses showed that the base case was driven predominantly by differences in hypoglycemia; abolishing these differences reduced incremental quality-adjusted life expectancy to 0.07 quality-adjusted life-years, yielding an incremental cost-effectiveness ratio of €74,622 per quality-adjusted life-year gained. Rapid-acting analog insulin is associated with beneficial outcomes in patients with type 1 diabetes and is likely to be considered cost effective in the German setting vs. regular human insulin.

EADSG Guidelines: Insulin Therapy in Diabetes.

Executive Summary and Recommendations A diagnosis of diabetes or hyperglycemia should be confirmed prior to ordering, dispensing, or administering insulin (A).Insulin is the primary treatment in all patients with type 1 diabetes mellitus (T1DM) (A).Typically, patients with T1DM will require initiation with multiple daily injections at the time of diagnosis. This is usually short-acting insulin or rapid-acting insulin analogue given 0 to 15 min before meals together with one or more daily separate injections of intermediate or long-acting insulin. Two or three premixed insulin injections per day may be used (A).The target glycated hemoglobin A1c (HbA1c) for all children with T1DM, including preschool children, is recommended to be < 7.5% (< 58 mmol/mol). The target is chosen aiming at minimizing hyperglycemia, severe hypoglycemia, hypoglycemic unawareness, and reducing the likelihood of development of long-term complications (B).For patients prone to glycemic variability, glycemic control is best evaluated by a combination of results with self-monitoring of blood glucose (SMBG) (B).Indications for exogenous insulin therapy in patients with type 2 diabetes mellitus (T2DM) include acute illness or surgery, pregnancy, glucose toxicity, contraindications to or failure to achieve goals with oral antidiabetic medications, and a need for flexible therapy (B).In T2DM patients, with regards to achieving glycemic goals, insulin is considered alone or in combination with oral agents when HbA1c is ≥ 7.5% (≥ 58 mmol/mol); and is essential for treatment in those with HbA1c ≥ 10% (≥ 86 mmol/mol), when diet, physical activity, and other antihyperglycemic agents have been optimally used (B).The preferred method of insulin initiation in T2DM is to begin by adding a long-acting (basal) insulin or once-daily premixed/co-formulation insulin or twice-daily premixed insulin, alone or in combination with glucagon-like peptide-1 receptor agonist (GLP-1 RA) or in combination with other oral antidiabetic drugs (OADs) (B).If the desired glucose targets are not met, rapid-acting or short-acting (bolus or prandial) insulin can be added at mealtime to control the expected postprandial raise in glucose. An insulin regimen should be adopted and individualized but should, to the extent possible, closely resemble a natural physiologic state and avoid, to the extent possible, wide fluctuating glucose levels (C).Blood glucose monitoring is an integral part of effective insulin therapy and should not be omitted in the patient’s care plan. Fasting plasma glucose (FPG) values should be used to titrate basal insulin, whereas both FPG and postprandial glucose (PPG) values should be used to titrate mealtime insulin (B).Metformin combined with insulin is associated with decreased weight gain, lower insulin dose, and less hypoglycemia when compared with insulin alone (C).Oral medications should not be abruptly discontinued when starting insulin therapy because of the risk of rebound hyperglycemia (D).Analogue insulin is as effective as human insulin but is associated with less postprandial hyperglycemia and delayed hypoglycemia (B).The shortest needles (currently the 4-mm pen and 6-mm syringe needles) are safe, effective, and less painful and should be the first-line choice in all patient categories; intramuscular (IM) injections should be avoided, especially with long-acting insulins, because severe hypoglycemia may result; lipohypertrophy is a frequent complication of therapy that distorts insulin absorption, and therefore, injections and infusions should not be given into these lesions and correct site rotation will help prevent them (A).Many patients in East Africa reuse syringes for various reasons, including financial. This is not recommended by the manufacturer and there is an association between needle reuse and lipohypertrophy. However, patients who reuse needles should not be subjected to alarming claims of excessive morbidity from this practice (A).Health care authorities and planners should be alerted to the risks associated with syringe or pen needles 6 mm or longer in children (A).

Rapid-acting insulin analogue cost effective in Germany

Rapid-acting insulin analogue cost effective in Germany

New Medications for the Treatment of Diabetes.

New Medications for the Treatment of Diabetes.

Comparison of Efficacy and Safety of Lispro and Aspart Evaluated by Continuous Glucose Monitoring System in Patients with Newly Diagnosed Type 2 Diabetes.

Objective To compare the effect of the rapid-acting insulin analogues (RAIAs) aspart (NovoRapid) and lispro (Prandilin) on glycemic variations by continuous glucose monitoring system (CGMS) in patients within newly diagnosed type 2 diabetes mellitus (T2DM) receiving continuous subcutaneous insulin infusion (CSII) and metformin intensive therapy. Methods This is a single-blind randomized controlled trial. A total of 110 patients with newly diagnosed T2DM and with hemoglobin A1c (HbA1c%) above 9% was hospitalized and randomly divided into two groups: group Asp (NovoRapid group) and group Lis (Prandilin group). They all received CSII and metformin therapy. Treatments were maintained for 2-3 weeks after the glycaemic target was reached. C-peptide and insulin and fructosamine were determined. CGMS was continuously applied for 4 days after reaching the glycemic target. Results There were no significant differences in daily dosages of insulin, fasting plasma C-P and 2 h postprandial C-P and insulin, and fructosamine at the baseline and endpoint between the groups Asp and Lis. No significant differences were seen in the 24 h mean amplitude of glycemic excursions (MAGE), 24 h mean blood glucose (MBG), the standard deviation of the MBG (SDBG), fasting blood glucose, number of glycemic excursion (NGE), and the incidence of hypoglycemia between the two groups. Similarly, no significant differences were found in areas under the curve (AUC) of glucose above 10.0 mmol/L or the decremental area over the curve (AOC) of glucose below 3.9 mmol/L between the two groups. Conclusions Lispro and aspart had the similar ability to control the glycemic variations in patients with newly diagnosed T2DM. This study was registered with ClinicalTrials.gov, number ChiCTR-IPR-17010338.

Rethinking the Viability and Utility of Inhaled Insulin in Clinical Practice.

Despite considerable advances in pharmacotherapy and self-monitoring technologies in the last decades, a large percentage of adults with diabetes remain unsuccessful in achieving optimal glucose due to suboptimal medication adherence. Contributors to suboptimal adherence to insulin treatment include pain, inconvenience, and regimen complexity; however, a key driver is hypoglycemia. Improvements in the PK/PD characteristics of today's SC insulins provide more physiologic coverage of basal and prandial insulin requirements than regular human insulin; however, they do not achieve the rapid on/rapid off characteristics of endogenously secreted insulin seen in healthy, nondiabetic individuals. Pulmonary administration of prandial insulin represents an attractive option that overcomes limitations of SC insulin by providing more a rapid onset of action and a faster return of action to baseline levels than SC administration of rapid-acting insulin analogs. This article reviews the unique PK/PD properties of a novel inhaled formulation that support its use in patient populations with T1D or T2D.

Postprandial Dosing of Bolus Insulin in Patients with type 1 Diabetes: a Cross-sectional Study Using Data From the T1d Exchange Registry

To assess the prevalence and characteristics of patients with type 1 diabetes (T1D) who dose bolus insulin postprandial (PostP) versus preprandial (PreP). Data for this cross-sectional study were obtained from 21,533 participants in the T1D Exchange Registry. Data were drawn from the enrollment questionnaire. Patients who dosed 'immediately before meal' or 'several minutes before meal' were classified as PreP. Patients who dosed 'during meal' or 'after meal' were classified as PostP. Data reported (PostP vs. PreP) are mean ± SD and percentage, as appropriate. After exclusion of patients who did not answer the dose-timing question or who selected 'not given regularly' or 'depends on glucose level prior to meal,' (4,229 of 25,762), 21,533 patients were included in the study. Ninety-nine percent of patients used rapid-acting insulin analogues; 32% dosed insulin PostP. Compared to PreP, children <18 years of age dosing PostP were characterized by higher glycated hemoglobin (HbA1c) (8.7 ± 1.5% [72 ± 16.4 mmol/mol] vs. 8.4 ± 1.7% [68 ± 18.6 mmol/mol]), larger insulin dose (1.2 ± 0.7 IU/kg/day vs. 1.1 ± 0.7 IU/kg/day), greater prevalence of history of hypoglycemia, and diabetic ketoacidosis. Adults who dosed PostP were characterized by younger age (33.0 ± 15.3 years vs. 39.5 ± 16.6 years), higher HbA1c (8.3 ± 1.5% [67 ± 16.4 mmol/mol] vs. 7.8 ± 1.5% [62 ± 16.4 mmol/mol]), and larger insulin dose (1.0 ± 0.6 IU/kg/day vs. 0.9 ± 0.5 IU/kg/day) than PreP. This study reveals that a large proportion of patients dose bolus insulin PostP. Despite the use of current rapid-acting insulin analogues, patients who dose PostP are characterized by poorer glycemic control in all patients and a greater prevalence of history of severe hypoglycemia and diabetic ketoacidosis in children. BMI = body mass index; CGM = continuous glucose monitoring; DKA = diabetic ketoacidosis; HbA1c = glycated hemoglobin; PostP = postprandial; PreP = preprandial; SMBG = self-monitored blood glucose; T1D = type 1 diabetes.

Improving postprandial hyperglycemia in patients with type 2 diabetes already on basal insulin therapy: Review of current strategies.

A large number of patients with type 2 diabetes (T2D) on basal insulin do not reach their HbA1c goals and require additional therapy to address postprandial hyperglycemia. Guidelines from expert bodies have outlined several approaches to accomplish postprandial glucose (PPG) control, and recent literature suggests several more. This article provides strategies for primary care physicians caring for patients with T2D who do not achieve glycemic control with basal insulin alone. Current treatment guidelines and strategies for improving PPG control are reviewed, including the efficacy, safety, and cost-effectiveness of rapid-acting insulin (RAI) analogs, premixed insulin, glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), dipeptidyl peptidase 4 inhibitors, sodium-glucose cotransporter 2 inhibitors, and α-glucosidase inhibitors. Other approaches, such as combinations of newer basal insulin plus RAI and a fixed-ratio combination of basal insulin and a GLP-1 RA, are also described.

Evaluation of the timing and coordination of prandial insulin administration in the hospital.

The objective of this study was to examine the relationship between measures of coordinated insulin delivery and capillary blood glucose (CBG) levels among hospitalized patients and to assess nurse perceptions of insulin administration. Hospitalized patients (n=451) receiving rapid acting insulin analog (RAIA) using carbohydrate counting were retrospectively analyzed. Nurses (n=35) were asked to complete an 18-item anonymous survey assessing perception of RAIA dosing. The median time from breakfast CBG to RAIA dose was 93 (IQR 57-138) min. There was no association between timeliness measures and mean CBG at lunch or dinner. Hypoglycemia was rare (N=2). More than half (54%) of nurses were confident all of the time in determining the correct dose of RAIA, though none were confident in administering it on time. The majority of nurses perceived an electronic dosing calculator and a patient reminder to notify the nurse at the end of the meal favorably. The data demonstrate suboptimal coordination of CBG monitoring and insulin doses using a flexible meal insulin dosing strategy, though there was minimal impact on glycemic control. Nurses reported high confidence in the ability to calculate the correct insulin dose but not in the ability to administer it on time.

Clinical effects, cardiovascular and renal outcomes associated with rapid-acting insulin analogs among individuals with type 2 diabetes: a nation-wide observational cohort study

BackgroundRapid-acting insulin analogs (RAIs) have not been examined for long-term safety in randomized clinical trials. We performed a nationwide longitudinal cohort study among individuals with type 2 diabetes (T2DM) to address cardiovascular safety and mortality among users of lispro, aspart and glulisine insulins.MethodsWe used four national registers, following patients previously not treated with RAI but with continuous use of RAIs in 2005-2014 up to 6.4 years, to examine HbA1c and weight, and the occurrence of severe hyperglycemia or hypoglycemia, renal failure, cardiovascular events or death. The treatment groups were compared using a weighted Cox proportional hazards model.ResultsWe included 17,620 patients, mean age slightly higher than 60 years, diabetes duration 9.9–11.7 years, mean BMI 30.5 kg/m2, HbA1c around 70 mmol/mol (8.6% NGSP), and 40.9–54.0% of the patients exhibiting eGFR <60 ml/min/1.73 m2 in the three groups. Around 95% of the patients also used another insulin, and 24.2–24.7% had a history of cardiovascular disease (CVD).Mean HbA1c and weight levels were stable and similar. Incidence rates of death were 234.4, 284.9 and 156.7 per 1000 person-years among users of lispro, aspart, and glulisine; incidence rates of all cardiovascular events were 668.4, 622.4, and 699.5 per 1000 person-years, respectively.There were no differences in mortality, CVD, renal failure or severe hypoglycemia or hyperglycemia, although a lower mortality risk in patients on glulisine compared with aspart, and lower risk of stroke in users of glulisine was suggested. The risk of severe hyperglycemia was higher with lispro than aspart, and lower of severe hypoglycemia than aspart or glulisine among the older age group.ConclusionsOverall, there do not appear to be any major important differences in effects on hypoglycemia, hyperglycemia, weight or long-term safety between the three available RAIs among insulin-naive individuals with T2DM in clinical practice.

Review of Evidence for Adult Diabetic Ketoacidosis Management Protocols.

Diabetic ketoacidosis (DKA) is an endocrine emergency with associated risk of morbidity and mortality. Despite this, DKA management lacks strong evidence due to the absence of large randomised controlled trials (RCTs). To review existing studies investigating inpatient DKA management in adults, focusing on intravenous (IV) fluids; insulin administration; potassium, bicarbonate, and phosphate replacement; and DKA management protocols and impact of DKA resolution rates on outcomes. Ovid Medline searches were conducted with limits "all adult" and published between "1973 to current" applied. National consensus statements were also reviewed. Eligibility was determined by two reviewers' assessment of title, abstract, and availability. A total of 85 eligible articles published between 1973 and 2016 were reviewed. The salient findings were (i) Crystalloids are favoured over colloids though evidence is lacking. The preferred crystalloid and hydration rates remain contentious. (ii) IV infusion of regular human insulin is preferred over the subcutaneous route or rapid acting insulin analogues. Administering an initial IV insulin bolus before low-dose insulin infusions obviates the need for supplemental insulin. Consensus-statements recommend fixed weight-based over "sliding scale" insulin infusions although evidence is weak. (iii) Potassium replacement is imperative although no trials compare replacement rates. (iv) Bicarbonate replacement offers no benefit in DKA with pH > 6.9. In severe metabolic acidosis with pH < 6.9, there is lack of both data and consensus regarding bicarbonate administration. (v) There is no evidence that phosphate replacement offers outcome benefits. Guidelines consider replacement appropriate in patients with cardiac dysfunction, anaemia, respiratory depression, or phosphate levels <0.32 mmol/L. (vi) Upon resolution of DKA, subcutaneous insulin is recommended with IV insulin infusions ceased with an overlap of 1-2 h. (vii) DKA resolution rates are often used as end points in studies, despite a lack of evidence that rapid resolution improves outcome. (viii) Implementation of DKA protocols lacks strong evidence for adherence but may lead to improved clinical outcomes. There are major deficiencies in evidence for optimal management of DKA. Current practice is guided by weak evidence and consensus opinion. All aspects of DKA management require RCTs to affirm or redirect management and formulate consensus evidence-based practice to improve patient outcomes.

Diabetes medication pharmacology

Diabetes medication pharmacology

Diabetic ketoacidosis: Should current management include subcutaneous insulin injections?

Diabetic ketoacidosis is a well-known acute complication in patients with both type 1 andtype 2 diabetes mellitus. Although mortality has decreased considerably, it remains an importantcause for admission to intensive care units. Medical management includes intravenous fluidtherapy, insulin, correction of electrolyte abnormalities, and addressing the precipitating factorwhich in most cases is infection or non-compliance with insulin therapy. Usually patients withdiabetic ketoacidosis are admitted to the intensive care unit for continuous infusion of insulin;however, the development of rapid acting insulin analogues has made it possible to treatmild to moderate diabetic ketoacidosis with subcutaneous insulin. Although studies usingsubcutaneous insulin include only a small number of patients, this approach seems as effectiveas intravenous insulin infusions in patients with mild to moderate diabetic ketoacidosis. Diabeticeducation and close follow-up for patients admitted for diabetic ketoacidosis remain essentialto avoid recurrence and readmissions.Keywords: Diabetic ketoacidosis, acute complication in diabetes, rapid acting insulinanalogues, subcutaneous insulin in diabetic ketoacidosis

Insulin therapy in neonatal diabetes mellitus: a review of the literature.

Neonatal diabetes mellitus (NDM) is a rare disorder, and guidance is limited regarding its optimal management. We reviewed insulin usage in NDM, with a focus on continuous subcutaneous insulin infusion (CSII). A PubMed search identified 40 reports of patients with NDM treated with insulin published between 1994 and 2016. Data concerning treatment of NDM are limited. CSII resolves some of the issues associated with insulin therapy in neonates. No clinical trials of CSII in NDM have been reported. Case reports suggest that CSII is a safe and effective means of treating NDM. CSII was initiated to improve glycaemic control, for practicality and convenience, and to overcome difficulties associated with the maintenance of long-term intravenous catheters. CSII can provide better glycaemic control than multiple daily injections, with few hypoglycaemic events. Continuous glucose monitoring integrated with the pump helps provide more precise control of blood glucose levels. CSII generally uses short-acting insulin or rapid-acting insulin analogues, and those that are approved for use in neonates appear to be appropriate for the treatment of NDM using an insulin pump. Information from case reports indicates that CSII is safe and effective for the management of NDM.

Pharmacokinetic and Pharmacodynamic Variability of Insulin When Administered by Jet Injection.

Background:Jet injection has been shown to accelerate the absorption and action of rapid-acting insulin. In this study, we compared the variability of absorption characteristics between jet injection and conventional administration of the rapid-acting insulin analogue aspart.Methods:A total of 30 healthy volunteers were enrolled in this randomized controlled blinded parallel study. On two test days, they received insulin aspart (0.2 units/kg body weight), either by jet injection or conventional pen, followed by a 6-hour euglycemic glucose clamp. Plasma glucose and insulin levels and glucose infusion rates were measured every 5 to 10 minutes to calculate the variability in pharmacological endpoints.Results:Jet injection advanced the times until maximal insulin concentration (T-INSmax) and glucose infusion rate (T-GIRmax) by ~40% (both P < .01). The difference between the two test days for these endpoints did not differ between jet injection and conventional administration (T-INSmax: 7.3 ± 1.9 vs 22.3 ± 6.3 min, P = .074; T-GIRmax: 24.0 ± 3.5 vs 27.3 ± 6.6 min, P = .66). The corresponding intraindividual coefficients of variation for injection by jet or conventional pen were 15.3 ± 3.3 and 22.0 ± 4.6% (P = .25, Pvariance = .044) for T-INSmax and 34.5 ± 5.1 and 21.2 ± 4.6% for T-GIRmax (P = .064, Pvariance = .62). The variance in maximal insulin concentration was significantly less after conventional administration (P = .039). The variance in total glucose-lowering effect and total insulin exposure did not differ (P = .93 and P = .32)Conclusion:Using a jet injector for insulin administration was associated with slightly altered variability in pharmacokinetic endpoints, but with about similar variability in pharmacodynamic endpoints compared to conventional administration. Variability in these endpoints remains considerable, regardless of the method of insulin administration.

Comparison of jet injector and insulin pen in controlling plasma glucose and insulin concentrations in type 2 diabetic patients.

This study is conducted to investigate efficacy of an insulin jet injector and an insulin pen in treatment of type 2 diabetic patients. Sixty patients with type 2 diabetes were treated with rapid-acting insulin (regular insulin) and insulin analog (insulin aspart) using the jet injector and the pen in 4 successive test cycles. Postprandial glucose and insulin concentrations in blood were measured over time. Areas under curves of glucose and the insulin were calculated, and efficacy of 2 injection methods in treatment of the diabetes was compared. Regular insulin and insulin aspart administration by the jet injector showed significant decreases in plasma glucose levels as compared to the pen injection (P < 0.05). Postprandial plasma glucose excursions at the time points of 0.5 to 3 hours were obviously lower in the jet-treated patients than the pen-treated ones (P < 0.05). Postprandial plasma insulin levels were markedly higher in the jet-treated patients than the pen-treated ones (P < 0.05). Area under the glucose curve in the pen-treated patients was significantly increased as compared to the jet-treated ones (P < 0.01). Efficacy of the insulin jet injector in treatment of type 2 diabetic patients is obviously superior to the insulin pen in regulating plasma glucose and insulin levels.

Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial

We assessed whether fully closed-loop insulin delivery (the so-called artificial pancreas) is safe and effective compared with standard subcutaneous insulin therapy in patients with type 2 diabetes in the general ward. For this single-centre, open-label, parallel-group, randomised controlled trial, we enrolled patients aged 18 years or older with type 2 diabetes who were receiving insulin therapy. Patients were recruited from general wards at Addenbrooke's Hospital, Cambridge, UK. Participants were randomly assigned (1:1) by a computer-generated minimisation method to receive closed-loop insulin delivery (using a model-predictive control algorithm to direct subcutaneous delivery of rapid-acting insulin analogue without meal-time insulin boluses) or conventional subcutaneous insulin delivery according to local clinical guidelines. The primary outcome was time spent in the target glucose concentration range of 5·6-10·0 mmol/L during the 72 h study period. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01774565. Between Feb 20, 2015, and March 24, 2016, we enrolled 40 participants, of whom 20 were randomly assigned to the closed-loop intervention group and 20 to the control group. The proportion of time spent in the target glucose range was 59·8% (SD 18·7) in the closed-loop group and 38·1% (16·7) in the control group (difference 21·8% [95% CI 10·4-33·1]; p=0·0004). No episodes of severe hypoglycaemia or hyperglycaemia with ketonaemia occurred in either group. One adverse event unrelated to study devices occurred during the study (gastrointestinal bleed). Closed-loop insulin delivery without meal-time boluses is effective and safe in insulin-treated adults with type 2 diabetes in the general ward. Diabetes UK; European Foundation for the Study of Diabetes; JDRF; National Institute for Health Research Cambridge Biomedical Research Centre; Wellcome Trust.

A randomized crossover study of the efficacy and safety of switching from insulin glargine to insulin degludec in children with type 1 diabetes.

This study implemented a randomized crossover design to evaluate the efficacy and safety of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in 18 children (11 males, 7 females; age 11.0 ± 0.5 years) with type 1 diabetes. All subjects had previously used IGlar once daily at bedtime. We compared fasting plasma glucose (FPG) and HbA1c levels, frequencies of overall and nocturnal (2200 h - 0659 h) hypoglycemia, and basal insulin dose at the baseline with those measured during a 24-week period during which IGlar or IDeg was administered in combination with pre-meal rapid acting insulin analogues. IDeg was initially given at the same dose as IGlar but was subsequently titrated to achieve FPG levels of 90-140 mg/dL. There were no significant changes in FPG and HbA1c levels from the baseline during the 24-week study period with IGlar or IDeg. The daily basal insulin dose did not significantly differ with IGlar or IDeg. Although the frequencies of overall hypoglycemia were similar, nocturnal hypoglycemia significantly decreased at 12 and 24 weeks from the baseline with IDeg use (2 ± 0.4 vs. 0 ± 0.3, 0 ± 0.5 episodes/month, both P <0.05), whereas no significant change in the frequency of nocturnal hypoglycemia was observed with IGlar. No severe hypoglycemia occurred during the study period with either basal insulin analogues. These results suggest that IDeg, injected once at bedtime, may provide similar glycemic control as IGlar while better reducing the risk of nocturnal hypoglycemia in children with type 1 diabetes.

Regular Insulin Administered With the V-Go Disposable Insulin Delivery Device in a Clinical Diabetes Setting: A Retrospective Analysis of Efficacy and Cost.

People with diagnosed diabetes incur high average medical expenditures of ∼$13,700 per year, creating a cost burden for themselves and their health plan insurers (1). According to the American Diabetes Association (ADA), 97% of the $245 billion cost for diabetes care in the United States is provided by government and commercial insurance payers (2). The cost of diabetes therapy, including insulin, accounts for 12% of the total cost of diabetes care, and managing diabetes to prevent complications is becoming less affordable (2). Insulin is still considered the most potent glucose-lowering agent available. ADA and the European Association for the Study of Diabetes recently issued guidelines for the treatment of type 2 diabetes that identified insulin replacement therapy as a key component of effective diabetes management over the course of the disease (3). The use of rapid-acting insulin analogs (RAIs) has surpassed the use of regular human insulin (RHI) in the majority of basal-bolus and bolus-only therapy regimens (4). Ninety-six percent of patients with type 2 diabetes who take insulin in the United States now use an analog insulin for basal and/or prandial coverage—an increase from just 19% in 2000 (5). This increase in utilization may be the result of many factors, including the pharmacokinetic differences among the insulins, marketing developments, and formulary health plan coverage (6). Along with this increase in the utilization of RAIs, there has been an increase in costs to patients and health plans. This is especially apparent when the costs of RAIs are compared to those of RHI as a therapy alternative. The steep increase in the cost of RAIs has led many patients to partially or totally discontinue their insulin therapy because of affordability issues (1). Several studies have shown that low adherence to diabetes therapy is also associated with higher medication costs …

A comparison of the pharmacodynamic profiles of jet-injected regular human insulin versus conventionally administered insulin aspart in healthy volunteers

AimsRapid-acting insulin analogues are generally preferred over regular human insulin because of their more immediate onset of action and shorter time-action profile. However, these analogues may not always be tolerated by or universally available for people with insulin-requiring diabetes. Jet injection has been demonstrated to facilitate faster insulin absorption. We determined whether administration of regular human insulin by jet injection achieves the same pharmacological properties as that of a rapid-acting insulin analogue. MethodsTwenty healthy volunteers received regular human insulin (0.2units/kg) by jet injection. Glucose 20% was infused intravenously to maintain euglycaemia over six hours. The glucose infusion rates (GIR) were determined to compare pharmacological profiles. These profiles were compared with data from two other studies in which a similar dose of insulin aspart was administered by conventional pen. ResultsRegular human insulin by jet injection had a faster onset of glucose-lowering effect compared to aspart by conventional pen (T-GIR50%, 30.8±2.9 versus 43.1±3.2min, P<0.01). There were no differences in time to maximal GIR (106.1±11.9 versus 95.8±9.2min, P=0.50), maximal GIR (8.6±0.7 versus 7.7±0.7mg/kg/min, P=0.0.33), total glucose-lowering effect (101.0±9.8 versus 87.6±7.0g, P=0.28), and time until 50% of glucose disposal (144.8±5.6 versus 151.3±5.1min, P=0.39). ConclusionsJet-injected regular human insulin had a pharmacological profile that was essentially not dissimilar from that of aspart insulin administered by conventional pen, and can therefore be used as an alternative for conventionally administered rapid-acting insulin analogues.