Basal-bolus Therapy Research Articles

The effect of basal-bolus therapy varies with baseline 1,5-anhydroglucitol level in people with Type 2 diabetes: a post hoc analysis.

AimsTo investigate the impact of baseline 1,5‐anhydroglucitol on the treatment effect of basal–bolus therapy in people with Type 2 diabetes.Methods Post hoc analysis of onset 3, an 18‐week, randomized, phase 3 trial evaluating the efficacy and safety of fast‐acting insulin aspart in basal–bolus therapy (n = 116) vs. basal insulin‐only therapy (n = 120) in people with Type 2 diabetes. The estimated treatment difference in change from baseline in HbA1c was investigated for different cut‐off values of baseline 1,5‐anhydroglucitol (2, 3, 4, 5 and 6 μg/ml).ResultsThe estimated treatment difference in change from baseline in HbA1c between basal–bolus therapy and basal insulin‐only therapy was statistically significantly greater in participants with baseline 1,5‐anhydroglucitol ≤3 μg/ml (n = 34) vs. >3 μg/ml (n = 198) [estimated treatment difference (95% CI): −1.53% (−2.12; −0.94) vs. −0.82% (−1.07; −0.57); P‐value for interaction = 0.03]. The estimated treatment difference became more pronounced when comparing participants with 1,5‐anhydroglucitol ≤2 μg/ml (n = 15) vs. >2 μg/ml (n = 217) [estimated treatment difference (95% CI): −2.26% (−3.15; −1.36) vs. −0.85% (−1.08; −0.62); P‐value for interaction = 0.003]. For cut‐off values ≥4 μg/ml, estimated treatment differences were numerically greater below the cut‐off compared with above, although the interaction terms were not statistically significant.ConclusionThis analysis indicates that people with Type 2 diabetes with low 1,5‐anhydroglucitol have an added treatment benefit with basal–bolus therapy compared with people with higher 1,5‐anhydroglucitol. Further research is needed to clarify any clinical utility of these findings. Clinical Trials Registry No: NCT01850615

Physicians’ real-world experience with IDegLira: results of a European survey

ObjectiveThis study aimed to build on the current clinical findings and investigate physicians’ experiences and level of satisfaction in using insulin degludec/liraglutide (IDegLira) to treat patients with type 2 diabetes...

Multinational Consensus: Insulin Initiation with Insulin Degludec/Aspart (IDegAsp).

Insulin degludec/aspart (IDegAsp) is the first soluble insulin co-formulation, combining a long-acting insulin degludec (IDeg) and rapid-acting insulin aspart (IAsp). In type 2 diabetes patients with oral antidiabetes agent (OAD) inadequacy, insulin initiation with IDegAsp once daily provides superior long-term glycemic control compared to insulin glargine, with similar fasting plasma glucose (FPG) and insulin doses, and numerically lower rates of overall and nocturnal hypoglycemia. Furthermore, in patients with uncontrolled type 2 diabetes previously treated with insulins, IDegAsp twice daily effectively improves glycated hemoglobin and FPG, with fewer hypoglycemic episodes versus premix insulins and basal bolus therapy. In patients with type 1 diabetes mellitus, IDegAsp once daily with two doses of IAsp is a convenient, yet effective, regimen as compared to the conventional 4-5 injection-based basal bolus therapy. IDegAsp is an appropriate and reasonable option for initiation of insulin therapy in both type 1 and type 2 diabetes.

Clinical Benefits Over Time Associated with Use of V-Go Wearable Insulin Delivery Device in Adult Patients with Diabetes: A Retrospective Analysis.

IntroductionAdvances in insulin delivery have improved outcomes in patients with diabetes. This study evaluated the impact of V-Go® Wearable Insulin Delivery device on glycated hemoglobin (A1C) and insulin total daily dose (TDD) in patients with diabetes not achieving glycemic targets.MethodsElectronic medical record data was obtained for adult patients with A1C > 7% treated at a multicenter endocrine practice who initiated V-Go between August 2012 and August 2015. Data were collected at baseline and for up to four follow-up visits, and were analyzed overall, stratified by insulin use at baseline, and for patients prescribed a basal-bolus insulin regimen delivered by multiple daily injections (MDI) at baseline. Economic evaluations were conducted in patients previously prescribed MDI regimens.ResultsPatients (N = 103) were evaluated after a mean of 2, 6, 10, and 14 months of V-Go use. Baseline glycemic control was poor (A1C > 9%) in 59% of patients. Significant, sustained reductions in A1C compared with baseline were observed at every visit (p < 0.0001), with mean ± SE decrease of 1.67 ± 0.24% after 14 months. For patients prescribed insulin at baseline (n = 80), TDD was significantly reduced at all visits (p < 0.0001), with mean ± SE reduction of 17 ± 4.5 units/day at 14 months. Patients previously prescribed MDI therapy (n = 58) benefited from 1.53 ± 0.31% (p < 0.001) A1C reduction and TDD decrease of 30 ± 5 units/day after 14 months. Direct pharmacy wholesale acquisition costs for diabetes therapeutics were reduced by $25.00/patient/month.ConclusionUse of V-Go was associated with improved glycemic control and decreased TDD. For patients previously prescribed basal-bolus MDI therapy, switching to insulin therapy with V-Go resulted in pharmacy cost savings based on wholesale acquisition costs. V-Go offers an efficacious method of insulin delivery that improves outcomes in patients and can reduce costs.FundingValeritas, Inc.

Cost-Effectiveness of Insulin Degludec Versus Insulin Glargine U100 in Patients with Type 1 and Type 2 Diabetes Mellitus in Serbia.

IntroductionThis study investigates the cost-effectiveness of insulin degludec versus insulin glargine U100 in patients with type 1 and type 2 diabetes mellitus in Serbia.MethodsA cost-utility analysis, implementing a simple short-term model, was used to compare treatment costs and outcomes with degludec versus glargine U100 in patients with type 1 (T1DM) and type 2 diabetes (T2DM). Cost-effectiveness was analysed in a 1-year setting, based on data from clinical trials. Costs were estimated from the healthcare payer perspective, the Serbian Health Insurance Fund (RFZO). The outcome measure was the incremental cost-effectiveness ratio (ICER) or cost per quality-adjusted life-year (QALY) gained.ResultsDegludec is highly cost-effective compared with glargine U100 for people with T1DM and T2DM in Serbia. The ICERs are estimated at 417,586 RSD/QALY gained in T1DM, 558,811 RSD/QALY gained in T2DM on basal oral therapy (T2DMBOT) and 1,200,141 RSD/QALY gained in T2DM on basal-bolus therapy (T2DMB/B). All ICERs fall below the commonly accepted thresholds for cost-effectiveness in Serbia (1,785,642 RSD/QALY gained). In all three patient groups, insulin costs are higher with degludec than with glargine U100, but these costs are partially offset by savings from a lower daily insulin dose in T1DM and T2DMBOT, a reduction in hypoglycaemic events in all three patient groups and reduced costs of SMBG testing in the T2DM groups with degludec versus glargine U100.ConclusionDegludec is a cost-effective alternative to glargine U100 for patients with T1DM and T2DM in Serbia. Degludec may particularly benefit those suffering from hypoglycaemia or where the patient would benefit from the option of flexible dosing.FundingNovo Nordisk.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0426-0) contains supplementary material, which is available to authorized users.

A Review of Basal-Bolus Therapy Using Insulin Glargine and Insulin Lispro in the Management of Diabetes Mellitus.

Basal-bolus therapy (BBT) refers to the combination of a long-acting basal insulin with a rapid-acting insulin at mealtimes. Basal insulin glargine 100 U/mL and prandial insulin lispro have been available for many years and there is a substantial evidence base to support the efficacy and safety of these agents when they are used in BBT or basal-plus therapy for patients with type 1 or type 2 diabetes mellitus (T1DM, T2DM). With the growing availability of alternative insulins for use in such regimens, it seems timely to review the data regarding BBT with insulin glargine 100 U/mL and insulin lispro. In patients with T1DM, BBT with insulin glargine plus insulin lispro provides similar or better glycemic control and leads to less nocturnal hypoglycemia compared to BBT using human insulin as the basal and/or prandial component, and generally provides similar glycemic control and rates of severe hypoglycemia to those achieved with insulin lispro administered by continuous subcutaneous insulin infusion (CSII). Studies evaluating BBT with insulin glargine plus insulin lispro in patients with T2DM also demonstrate the efficacy and safety of these insulins. Available data suggest that BBT with insulin glargine and insulin lispro provides similar levels of efficacy and safety in pediatric and adult populations with T1DM and in adult patients and those aged more than 65 years with T2DM. These insulin preparations also appear to be safe and effective for controlling T2DM in people of different ethnicities and in patients with T1DM or T2DM and comorbidities.FundingEli Lilly and Company.

Basal-Bolus Insulin Therapy with Gla-300 During Hospitalization Reduces Nocturnal Hypoglycemia in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Study.

IntroductionAlthough reduction in the incidence of nocturnal hypoglycemia, as estimated by symptom or self-monitored plasma glucose, was shown to be more pronounced with 300 units/mL insulin glargine (Gla-300) than with 100 units/mL insulin glargine (Gla-100) in type 2 diabetes patients, the exact frequency of nocturnal hypoglycemia estimated with continuous glucose monitoring (CGM) has not been reported.MethodsForty patients with type 2 diabetes who were admitted for glycemic control with basal–bolus insulin therapy (BBT) were randomized into the Gla-100 and Gla-300 groups. Insulin doses were adjusted to maintain blood glucose levels within 100–120 mg/dL at each meal. Plasma glucose and C-peptide profiles were estimated serially after admission and before discharge. Daily CGM was also performed before discharge.ResultsIn the Gla-100 and Gla-300 groups, the mean duration of hospitalization was 15 ± 2 and 15 ± 1 days, respectively, and the mean basal insulin dose before discharge was 13 ± 7 and 15 ± 10 units, respectively. The dose of meal-time insulin was not different between the two groups. Compared with the Gla-300 group, the Gla-100 group had significantly lower nocturnal profiles of plasma glucose and C-peptide, but significantly higher frequency of CGM-estimated nocturnal hypoglycemia (10.7% ± 18.4% versus 1.2% ± 3.6%, P = 0.033).ConclusionIn type 2 diabetic patients, reduction in the incidence of CGM-estimated nocturnal hypoglycemia by BBT under tightly controlled diet therapy was higher with Gla-300 than with Gla-100.Trial RegistrationUMIN clinical trials registry (UMIN000023360).

Type 1 Diabetes in Children and Adolescents.

Type 1 Diabetes in Children and Adolescents.

Abstract #239 Insulin Degludec/Liraglutide (Ideglira) Achieved Non-Inferior A1c Reduction; Weight Loss and Fewer Hypoglycemic Episodes while Using a Simple Regimen with Fewer Injections and Dose Adjustments Compared with Basal–Bolus Therapy: An Analysis of Dual VII

Abstract #239 Insulin Degludec/Liraglutide (Ideglira) Achieved Non-Inferior A1c Reduction; Weight Loss and Fewer Hypoglycemic Episodes while Using a Simple Regimen with Fewer Injections and Dose Adjustments Compared with Basal–Bolus Therapy: An Analysis of Dual VII

Reduction of glycemic variability with Degludec insulin in patients with unstable diabetes

SummaryIntroductionDegludec (IDeg) is an ultralong-acting insulin, with stable pharmacodynamic profile which leads to lower fluctuations in glucose levels. The effect of IDeg has not been specifically assessed in patients with unstable diabetes, defined as increased glycemic variability (GV).MethodsA prospective before-after pilot study was conducted, including patients managed at Hospital Universitario San Ignacio in Bogotá, Colombia. The impact of the switch from a Glargine or Detemir insulin to a basal insulin regimen with IDeg for 12 weeks on GV measured by continuous glucose monitoring, on A1c levels, and on the incidence of episodes of global and nocturnal hypoglycemia was assessed in a group of patients with (coefficient of variation >34%) or without increased basal GV using a Generalised Estimating Equation (GEE) analysis.Results60 patients with basal bolus therapy and history of hypoglycemia were included. 18 patients had High GV (HGV). In this group a significant reduction of 11.1% of CV (95% CI: 6.3, 15.9, p = 0.01) was found. GEE analysis confirmed a higher impact over time on patients with HGV (p < 0.001). The percentage of patients with at least 1 episode of hypoglycemia decreased from 66.6% to 22.2% (p = 0.02) and from 37.14% to 5.71% (p < 0.01) for global and nocturnal hypoglycemia, respectively. Changes were not significant in patients with low GV. A reduction of A1c was observed in both groups (p < 0.001).ConclusionsThe results suggest that treatment with IDeg reduces GV, A1c levels and the incidence of global and nocturnal hypoglycemia events in patients with HGV, but not in patients with low GV.

Comparison of liraglutide plus basal insulin and basal-bolus insulin therapy (BBIT) for glycemic control, body weight stability, and treatment satisfaction in patients treated using BBIT for type 2 diabetes without severe insulin deficiency: A randomized prospective pilot study

AimsWe examined whether 0.9 mg/day liraglutide plus basal insulin (Lira-basal) is superior to basal-bolus insulin therapy (BBIT) for type 2 diabetes (T2DM) without severe insulin deficiency as determined by glucagon stimulation. MethodsFifty patients receiving BBIT were enrolled in this 24-week, prospective, randomized, open-labeled study. After excluding subjects with fasting C-peptide immunoreactivity (CPR) < 1.0 ng/mL and CPR increase < 1.0 ng/mL at 6 min post glucagon injection, 25 were randomly allocated to receive Lira-basal (n = 12) or continued BBIT (n = 13). Primary endpoint was change in HbA1c. Secondary endpoints were changes in body weight (BW), 7-point self-monitored blood glucose (SMBG), and Diabetes Treatment Satisfaction Questionnaire status (DTSQs) scores. ResultThe Lira-basal group demonstrated reduced HbA1c, whereas the BBIT group showed no change. BW was reduced in the Lira-basal group but increased in the BBIT group. The Lira-basal group also exhibited significantly reduced pre-breakfast and pre-lunch SMBG. DTSQs scores improved in the Lira-basal group but not the BBIT group. Plasma lipids, liver function, and kidney function were not significantly changed in either group. ConclusionsLira-basal therapy is superior to BBIT for T2DM without severe insulin deficiency.This study was registered with UMIN Clinical Trials Registry (UMIN000028313).

Implementation of a Multidisciplinary Educational Strategy Promoting Basal-Bolus Insulin Therapy Improves Glycemic Control and Reduces Length of Stay for Inpatients With Diabetes.

IN BRIEF “Quality Improvement Success Stories” are published by the American Diabetes Association in collaboration with the American College of Physicians, Inc. (ACP), and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of Clinical Diabetes. The following article describes an initiative to increase the use of basal-bolus insulin therapy for hyperglycemia in an inpatient setting and to evaluate its effects on patient outcomes compared to sliding-scale insulin therapy.

Comparative pharmacoeconomic evaluation of the treatment of type 2 diabetes mellitus with insulin degludec and insulin glargine in basal-bolus insulin therapy

Background. Type 2 diabetes mellitus (T2DM) and its complications are the major causes of long-term disability, significant performance loss, and premature mortality. Poor glycemic control, diabetes-related complications, and insulin therapy are associated with a significant increase in diabetes costs. The high cost of insulin analogues restricts reimbursement of their costs in some countries. Comprehensive clinical and economic assessments of different insulin analogues are the useful tool that may help policy-makers to set priorities in medicine provision within the existing system of healthcare funding.&#x0D; Aim — to compare the clinical and economic effectiveness of insulin degludec (100 U/mL) and insulin glargine (100 U/mL) in basal-bolus therapy for T2DM.&#x0D; Material and methods. Economic evaluation was based on cost effectiveness analysis (CEA), incremental cost-effectiveness ratio (ICER), cost effectiveness modelling (using 5-year time horizon), sensitivity analysis, and economic feasibility assessment. The clinical effectiveness was evaluated based on changes in the HbA1c level, frequency of severe hypoglycemia, and number of patient-years without complications. Only direct medical costs (costs for insulin therapy and treatment of severe hypoglycemia and diabetes-related complications) were analyzed.&#x0D; Results. The mean total direct medical costs amounted to 783,789 RUR/patient for degludec (of these, the cost of insulin therapy accounted for 68%) and 730,805 RUR/patient for glargine (of these, the costs for treatment of severe hypoglycemia and diabetes complications accounted for 62.58%). Degludec has a higher efficacy (additional HbA1c reduction by 0.52%), lower rate of severe hypoglycemia, and larger number of complication-free patient-years. Incremental costs (ICER) for degludec amounted to 101,236 RUR/patient (based on a decrease in the HbA1c level) and 353,224 RUR/patient (based on an increase in the number of complication-free patient-years); these values were 14.3- and 4.1-fold lower than the threshold of willingness-to-pay, respectively. Additional analysis of costs in patients with severe hypoglycemia rates of 3 and &gt;3 events/patient/year demonstrated that the estimated mean total costs for insulin degludec were lower by 5 and 23%, respectively, than those for insulin glargine.&#x0D; Conclusion. Our findings demonstrate the clinical and cost benefits of insulin degludec in T2DM patients, which supports its broader use in routine clinical practice for achieving the best glycemic control with minimal adverse effects.

Review of Insulin Therapy In Type 2 Diabetes Mellitus Ambulatory Patients

The purposes of this study were to review utilization of insulin therapy in type 2 diabetes mellitus out patients and identify its drug related problems. The data were collected cross-sectionally with purposive sampling method in the period March 2016 until May 2016 in Outpatient Clinic Universitas Airlangga Teaching Hospital Surabaya. The results of 240 patients showed that insulin was used as monotherapy insulin in 2,9% patients; combination 1 insulin & 1-4 OAD in 31,3%; basal bolus therapy 27,9%; combination basal−bolus therapy & 1-3 OAD 43,9%. Based on blood glucose target achievement, only 20,8% of patients achieve the target, 75,1% failed to achieve the target and 4,1% suffered from hypoglycemia. Drug related problems identified adverse drug reaction of antidiabetic therapy such as hypoglycemia (6.7%), nausea (3.8%), bloating (1.3%), increase of flatulency (2.9%) and inappropriate combination (0,4%). In conclusion insulin therapy was complicated and individually, most of the patients still did not reach the target and there was potential drug related problem in this patients group. So that caring from solid inter-professional health collaboration is needed

Neurological Complications in Patients with Type 1 Diabetes Mellitus with Different Methods of Insulin Therapy

Objectives. To study neurological complications in patients with type 1 diabetes mellitus (DM 1) receiving different methods of insulin therapy. Materials and methods. A total of 34 patients aged 18–40 years with DM 1 for 14.25 ± 9.25 years and receiving insulin therapy were studied. At the time of the study, patients of group 1 had been receiving insulin therapy by continuous subcutaneous infusion therapy (insulin pump) for 4.5 ± 1.5 years; the duration of the preceding period of standard therapy by repeated s.c. injections (basal-bolus therapy) was 11.3 ± 5.4 years. Patients of group 2 had been on basal-bolus therapy for 12.7 ± 7.7 years. Clinical evaluation of neurological status, autonomic changes, and testing on the MMSE, MoCA, HADS, TSS, NSS, and NDS were performed in patients of both groups. Results and conclusions. Patients of group 1, as compared with those of group 2, had less severe neuropathic, cognitive, and autonomic disorders and had a more favorable emotional background, indicating that the first treatment was more effective.

Cost-effectiveness analysis of IDegLira versus basal-bolus insulin for patients with type 2 diabetes in the Slovak health system.

AimsTo investigate the cost-effectiveness of once-daily insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in patients with type 2 diabetes not meeting glycemic targets on basal insulin from a healthcare payer perspective in Slovakia.MethodsLong-term clinical and economic outcomes for patients receiving IDegLira and basal-bolus therapy were estimated using the IMS CORE Diabetes Model based on a published pooled analysis of patient-level data.ResultsIDegLira was associated with an improvement in quality-adjusted life expectancy of 0.29 quality-adjusted life years (QALYs) compared with basal-bolus therapy. The average lifetime cost per patient in the IDegLira arm was EUR 2,449 higher than in the basal-bolus therapy arm. Increased treatment costs with IDegLira were partially offset by cost savings from avoided diabetes-related complications. IDegLira was highly cost-effective versus basal-bolus therapy with an incremental cost-effectiveness ratio of EUR 8,590 per QALY gained, which is well below the cost-effectiveness threshold set by the law in Slovakia.ConclusionIDegLira is cost-effective in Slovakia, providing a simple option for intensification of basal insulin therapy without increasing the risk of hypoglycemia or weight gain and with fewer daily injections than a basal-bolus regimen.

Use of 50/50 Premixed Insulin Analogs in Type 2 Diabetes: Systematic Review and Clinical Recommendations.

IntroductionPremixed insulin analogs represent an alternative to basal or basal–bolus insulin regimens for the treatment of type 2 diabetes (T2D). “Low-mix” formulations with a low rapid-acting to long-acting analog ratio (e.g., 25/75) are commonly used, but 50/50 formulations (Mix50) may be more appropriate for some patients. We conducted a systematic literature review to assess the efficacy and safety of Mix50, compared with low-mix, basal, or basal–bolus therapy, for insulin initiation and intensification.MethodsMEDLINE, EMBASE, Cochrane Database of Systematic Reviews, ClinicalTrials.gov, LillyTrials.com, and NovoNordisk-trials.com were searched (11 or 13 Dec 2016) using terms for T2D, premixed insulin analogs, and/or Mix50. Studies (randomized, nonrandomized, or observational; English only) comparing Mix50 with other insulins (except human) and reporting key efficacy [glycated hemoglobin (HbA1c), fasting and postprandial glucose] and/or safety (hypoglycemia, weight gain) outcomes were eligible for inclusion. Narrative reviews, letters, editorials, and conference abstracts were excluded. Risk of bias in randomized trials was assessed using the Cochrane tool.ResultsMEDLINE and EMBASE searches identified 716 unique studies, of which 32 met inclusion criteria. An additional three studies were identified in the other databases. All 19 randomized trials except one were open label; risk of other biases was generally low. Although not conclusive, the evidence suggests that Mix50 may provide better glycemic control (HbA1c reduction) and, particularly, postprandial glucose reduction in certain patients, such as those with high carbohydrate diets and Asian patients, than low-mix and basal therapy. Based on this evidence and our experience, we provide clinical guidance on factors to consider when deciding whether Mix50 is appropriate for individual patients.ConclusionsMix50 may be more suitable than low-mix therapy for certain patients. Clinicians should consider not only efficacy and safety but also patient characteristics and preferences when tailoring insulin treatment to individuals with T2D.FundingEli Lilly.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-017-0328-6) contains supplementary material, which is available to authorized users.

Basal-bolus insulin therapy in postoperative inpatients with diabetes mellitus: directions for future quality-improvement initiatives.

Aim:To determine variables associated with hyperglycemia and insulin therapy in postoperative inpatients with diabetes mellitus following a quality-improvement initiative.Materials & methods:Patients with diabetes mellitus following an elective surgical procedure (n = 782; 877 surgical procedures) were selected.Results:Age, hemoglobin A1c corticosteroids, insulin therapy and year of surgery were associated (p < 0.01) with hyperglycemia. Hemoglobin A1c, hyperglycemia, case mix index and corticosteroids were associated (p ≤ 0.03) with insulin therapy. Hyperglycemia and use of insulin varied by surgical specialty.Conclusion:Data could be used to modify current treatment algorithms. Variations in hyperglycemia and insulin use by surgical specialty require further investigation.

Cost-Effectiveness of IDegLira Versus Insulin Intensification Regimens for the Treatment of Adults with Type 2 Diabetes in the Czech Republic.

IntroductionThe aim of this study was to evaluate the long-term cost-effectiveness of the insulin degludec/liraglutide combination (IDegLira) versus basal insulin intensification strategies for patients with type 2 diabetes mellitus (T2DM) not optimally controlled on basal insulin in the Czech Republic.MethodsCost-effectiveness was evaluated using the QuintilesIMS Health CORE Diabetes model, an interactive internet-based model that simulates clinical outcomes and costs for cohorts of patients with diabetes. The analysis was conducted from the perspective of the Czech Republic public payer. Sensitivity analyses were conducted to explore the sensitivity of the model to plausible variations in key parameters.ResultsThe use of IDegLira was associated with an improvement in the quality-adjusted life expectancy of 0.31 quality-adjusted life-years (QALYs), at an additional cost of Czech Koruna (CZK) 107,829 over a patient’s lifetime compared with basal–bolus therapy, generating an incremental cost-effectiveness ratio (ICER) of CZK 345,052 per QALY gained. In a scenario analysis, IDegLira was associated with an ICER of CZK 693,763 per QALY gained compared to basal insulin + glucagon-like peptide-1 receptor agonist (GLP-1 RA). The ICERs are below the generally accepted willingness-to-pay threshold (CZK 1,100,000/QALY gained at the time of this analysis).ConclusionsResults from this evaluation suggest that IDegLira is a cost-effective treatment option compared with basal–bolus therapy and basal insulin + GLP-1 RA for patients with T2DM in the Czech Republic whose diabetes is not optimally controlled with basal insulin.FundingNovo Nordisk.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-017-0323-y) contains supplementary material, which is available to authorized users.

Relationship of Glucose Variability With Glycated Hemoglobin and Daily Mean Glucose: A Post Hoc Analysis of Data From 5 Phase 3 Studies

The association of glucose variability (GV) with other glycemic measures is emerging as a topic of interest. The aim of this analysis is to study the correlation between GV and measures of glycemic control, such as glycated hemoglobin (HbA1c) and daily mean glucose (DMG). Data from 5 phase 3 trials were pooled into 3 analysis groups: type 2 diabetes (T2D) treated with basal insulin only, T2D treated with basal-bolus therapy, and type 1 diabetes (T1D). A generalized boosted model was used post hoc to assess the relationship of the following variables with glycemic control parameters (HbA1c and DMG): within-day GV, between-day GV (calculated using self-monitored blood glucose and fasting blood glucose [FBG]), hypoglycemia rate, and certain baseline characteristics. Within-day GV (calculated using standard deviation [SD]) was found to have a significant influence on endpoints HbA1c and DMG in all 3 patient groups. Between-day GV from FBG (calculated using SD), within-day GV (calculated using coefficient of variation), and hypoglycemia rate were found to significantly influence the endpoint HbA1c in the T2D basal-only group. Lower within-day GV was significantly associated with improvement in DMG and HbA1c. This finding suggests that GV could be a marker in the early phases of new antihyperglycemic therapy development for predicting clinical outcomes in terms of HbA1c and DMG.