Disparities in Utilization and Outcomes With Continuous Subcutaneous Insulin Infusion in Young Adults With Type 1 Diabetes

ObjectiveTo evaluate which factors determine utilization patterns and outcomes of continuous subcutaneous insulin infusion (CSII) in young adults with type 1 diabetes.MethodsUtilizing the Optum deidentified electronic health record data set between 2008 to 2018 to perform a retrospective cohort study, we identified 2104 subjects with type 1 diabetes aged 18 to 30 years. We evaluated the effect of race on determining CSII utilization, HbA1c (%), and hospital admission for diabetic ketoacidosis (DKA). Crude and adjusted estimates were computed using logistic regression and linear mixed models.ResultsThere was low CSII utilization among individuals who were Black, Hispanic, male, and those with governmental insurance. These groups also demonstrated higher HbA1c levels. Subjects who were Black, Hispanic, and those with governmental insurance had higher odds of DKA. Even when commercially insured, Black and Hispanic subjects demonstrated higher HbA1c levels, and Black individuals had higher odds of DKA.ConclusionIn a large electronic health record database in the U.S., there was low CSII utilization overall, particularly in Black and Hispanic minorities, despite CSII showing superior HbA1c control without an increase in DKA events.     

Evaluation of Lipohypertrophy in Patients With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injections or Continuous Subcutaneous Insulin Infusion

ObjectiveTo determine lipohypertrophy (LH) in patients with type 1 diabetes mellitus (T1DM) on multiple daily insulin injections (MDII) or continuous subcutaneous insulin infusion (CSII) and to reveal the factors associated with the development and severity of LH.MethodsSixty-six patients with T1DM treated with MDII (n = 35, 53%) or CSII (n = 31, 47%) for at least 1 year were included. LH localizations were detected with palpation and ultrasonography (USG).ResultsThe LH detection rate with USG was significantly higher than that by palpation in the whole group (P < .001). The LH was detected with USG in 30 (85.7%) patients in the MDII group and 22 (71.0%) patients in the CSII group (P = .144). Advanced LH was detected in 13 (37.1%) of the patients treated with MDII and in 3 (9.7%) of the patients treated with CSII. LH was more severe in the MDII group than in the CSII group (P = .013). Diabetes duration and length of infusion set use were significantly longer and body mass index, hypoglycemia, and complication rates were higher in patients with LH than those in patients without LH (P < .05). A positive correlation was found between LH severity and HbA1C and insulin dose (P < .05, for both). MDII as insulin administration method, incorrect rotation, and a history of ketosis were found to be the most related factors with LH severity in a multiple linear regression analysis (P < .05).ConclusionUSG might be an effective approach for detecting and evaluating the severity of LH. MDII might cause more severe LH than CSII in patients with T1DM. In this study, LH was found to be associated mostly with incorrect rotation technique and a history of ketosis.     

持续皮下输注赖脯胰岛素治疗老年非初诊2型糖尿病患者临床观察

目的：观察比较持续皮下输注赖脯胰岛素与常规注射预混赖脯胰岛素对老年非初诊2型糖尿病患者的疗效与安全性。方法：将58例老年2型糖尿病患者随机分为观察组（29例）与对照组（29例）,观察组用赖脯胰岛素经胰岛素泵持续皮下输注（CSI-I）,对照组用精蛋白锌重组赖脯胰岛素25注射液,2次／d,常规皮下注射。两组患者均给予糖尿病教育、饮食控制及适量运动,共治疗2周。比较治疗前后两组患者的血糖、胰岛素用量、血糖达标时间以及低血糖发生率。结果：治疗后两组患者空腹血糖、餐后血糖均较治疗前下降（P〈0．05）,观察组血糖达标时间、胰岛素用量均明显低于对照组（P〈0．05）。两组低血糖发生率无明显差异。结论：持续皮下输注赖脯胰岛素具有较好的疗效与安全性,是控制老年非初诊2型糖尿病患者较佳的方法。     

持续皮下输注赖脯胰岛素治疗老年非初诊2 型糖尿病患者临床观察

目的:观察比较持续皮下输注赖脯胰岛素与常规注射预混赖脯胰岛素对老年非初诊2型糖尿病患者的疗效与安全性。方法:将58例老年2型糖尿病患者随机分为观察组(29例)与对照组(29例),观察组用赖脯胰岛素经胰岛素泵持续皮下输注(CSI-I),对照组用精蛋白锌重组赖脯胰岛素25注射液,2次/d,常规皮下注射。两组患者均给予糖尿病教育、饮食控制及适量运动,共治疗2周。比较治疗前后两组患者的血糖、胰岛素用量、血糖达标时间以及低血糖发生率。结果:治疗后两组患者空腹血糖、餐后血糖均较治疗前下降(P<0.05),观察组血糖达标时间、胰岛素用量均明显低于对照组(P<0.05)。两组低血糖发生率无明显差异。结论:持续皮下输注赖脯胰岛素具有较好的疗效与安全性,是控制老年非初诊2型糖尿病患者较佳的方法。     

Fear of Needles in Children With Type 1 Diabetes Mellitus on Multiple Daily Injections and Continuous Subcutaneous Insulin Infusion

ObjectiveTo assess the prevalence of fear of needles and its effect on glycemic control in children with type 1 diabetes mellitus (T1DM) on multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII).MethodsPatients aged 6 to 17 years with T1DM on MDI or CSII (n = 150) were enrolled. All caregivers and patients aged ≥ 11 years completed a “Diabetes Fear of Injecting and Self-testing Questionnaire” (D-FISQ). Needle phobia was defined as a score ≥ 6 for fear of self-testing (FST), fear of injections (FI), and fear of infusion-site changes (FISC).ResultsPositive FST scores were noted in 10.0% and positive FI or FISC scores in 32.7% (caregivers’ responses). Patients aged 6 to 10 years on CSII had greater fear (FISC) than those on MDI (FI) (P = .010). FST was inversely related to the number of daily blood sugar checks (P = .003). Patients with positive scores for FI/ FISC or FST had significantly higher glycated hemoglobin (HbA1c) levels than those without. An inverse association was noted between positive FI/FISC scores and age of the patient (P = .029). Based on patient responses, FST severity was directly related to the age of the patient (P = .013).ConclusionNeedle phobia is common in children with T1DM. Although FI/FISC are more common in younger children, especially in those on CSII, FST is more often encountered in older patients. Patients with a more intense fear of needles have higher HbA1c levels and less frequent blood sugar monitoring. Identifying these patients may help improve glycemic control. (Endocr Pract. 2015; 21:46-53)     

Continuous Subcutaneous Infusion of Insulin Lispro in Children and Adolescents with Type 1 Diabetes Mellitus

ObjectiveTo provide a comprehensive review of insulin lispro administered by continuous subcutaneous insulin infusion (CSII) in children and adolescents.MethodsWe performed PubMed literature searches to identify clinical studies of insulin lispro administered via CSII within pediatric and adolescent populations.ResultsTwenty-six studies involving 2521 pediatric patients with type 1 diabetes mellitus met inclusion criteria. Of these, 10 were randomized controlled trials (RCTs), 6 of which compared insulin lispro CSII with multiple daily injection (MDI) therapy. We identified 7 additional prospective, nonrandomized studies and 9 retrospective studies. Within the RCTs, endpoint hemoglobin A_1c levels ranged from 6.3% to 8.5% for insulin lispro CSII therapy and from 6.2% to 8.7% for those trials with MDI comparator arms. In those trials that compared insulin lispro CSII with MDI, the endpoint hemoglobin A_1c achieved with insulin lispro was similar or improved compared with observations in the MDI treatment arm. In the RCTs, severe hypoglycemia rates of 0.1 to 0.3 episodes/patient per year were reported for insulin lispro CSII therapy; those trials with MDI comparator arms reported relatively similar severe hypoglycemia rates (0.1 to 0.5 episodes/patient per year). Events of diabetic ketoacidosis (DKA) were rare. Where reported, insulin lispro CSII and MDI therapy demonstrated a similar occurrence of DKA and incidence of severe hypoglycemia. Prospective and retrospective studies demonstrated results similar to the RCT findings.ConclusionsIn 26 studies of more than 2500 pediatric and adolescent patients with type 1 diabetes, with more than 1000 patients specifically receiving insulin lispro CSII, insulin lispro CSII therapy consistently demonstrated similar or improved efficacy and safety vs studied comparators. (Endocr Pract. 2012;18:418-424)     

持续皮下胰岛素注射对2型糖尿病合并肺部感染患者的疗效分析

目的:分析持续皮下注射胰岛素对2型糖尿病(T2DM)合并肺部感染患者的临床疗效。方法:将我院2010年6月至2013年6月收治的86例2型糖尿病合并肺部感染患者随机分为2组,分别采用胰岛素泵持续皮下注射(治疗组)和多次皮下注射胰岛素(对照组),观察患者血糖指标、血糖达标时间、低血糖发生率及肺部感染治愈率情况。结果:治疗后,两组患者的血糖均得到控制,治疗组的血糖指标变化、血糖达标时间及住院时间均优于对照组,差异均有统计学意义(均P0.05)。治疗组的低血糖发生率明显低于对照组,而肺部感染治愈率显著高于对照组,差异均有统计学意义(均P0.05)。结论:胰岛素泵持续皮下胰岛素注射在治疗2型糖尿病合并肺部感染患者中使用,血糖达标迅速,降低低血糖发生率,缩短住院时间,提高感染治愈率,临床效果好。     

Insulin Lispro with Continuous Subcutaneous Insulin Infusion is Safe and Effective in Patients With Type 2 Diabetes: A Randomized Crossover Trial of Insulin Lispro Versus Insulin Aspart

ObjectiveThis study provides clinical information regarding the use of insulin lispro versus insulin aspart in continuous subcutaneous insulin infusion (CSII) in adult patients with type 2 diabetes mellitus (T2D).MethodsAfter a 2-week lead-in period, 122 subjects treated with CSII therapy were randomized to 32 weeks of treatment during 2 separate 16-week treatment periods (TPs) with crossover beginning with insulin lispro (n = 60) or insulin aspart (n = 62). Glycated hemoglobin A1c (HbA1c), total daily insulin dose, and weight were recorded at the end of TP1 and TP2. Adverse events (AEs) and hypoglycemic events (overall, documented symptomatic, nocturnal, or severe) were recorded throughout the TPs. Data were analyzed using statistical methods that accounted for repeated measurements.ResultsA total of 107 subjects completed the study; 7 discontinued in TP1 and 8 discontinued in TP2. Insulin lispro was noninferior to insulin aspart in endpoint (weeks 16 and 32) HbA1c over TP1 and TP2 combined. Total daily insulin dose, weight change, and incidence and rates of hypoglycemia were not statistically significantly different between treatments. One case of severe hypoglycemia and 1 of diabetic ketoacidosis was observed with insulin aspart. One case of severe infusion site abscess was noted with insulin lispro. Overall, both insulin lispro and insulin aspart were well tolerated with similar AEs reported.ConclusionInsulin lispro and insulin aspart performed similarly after 16 weeks of treatment, with non-inferiority for HbA1c and no significant difference in parameters measured. These findings indicate that insulin lispro and insulin aspart can both be used safely and effectively in patients with T2D using CSII. (Endocr Pract. 2015;21:247-257)     

How Patients With Type 1 Diabetes Translate Continuous Glucose Monitoring Data into Diabetes Management Decisions

Objective: To understand how patients use continuous glucose monitoring (CGM) data in their diabetes management.Methods: We surveyed patients who regularly used CGM (>6 days per week), using 70 questions, many scenario-based. The survey had 6 sections: patient characteristics, general CGM use, hypoglycemia prevention and management, hyperglycemia prevention and management, insulin dosing adjustments (both for incidental hyperglycemia not at meals and at mealtimes), and real-time use versus retrospective analysis.Results: The survey was completed by 222 patients with type 1 diabetes. In response to a glucose of 220 mg/dL, the average correction dose adjustment based on rate of change arrows varied dramatically. Specifically, when the CGM device showed 2 arrows up (glucose increasing >3 mg/dL/minute), respondents stated they would increase their correction bolus, on average, by 140% (range, 0 to 600%). Conversely, 2 arrows down (glucose decreasing >3 mg/dL/minute) caused respondents to reduce their dose by 42%, with 24% omitting their dose entirely. Furthermore, 59% of respondents stated they would delay a meal in response to rapidly rising glucose, whereas 60% would wait until after a meal to bolus in response to falling glucose levels. With a glucose value of 120 mg/dL and a falling glucose trend, 70% of respondents would prophylactically consume carbohydrates to avoid hypoglycemia.Conclusion: CGM users utilize CGM data to alter multiple aspects of their diabetes care, including insulin dose timing, dose adjustments, and in hypoglycemia prevention. The insulin adjustments are much larger than common recommendations. Additional studies are needed to determine appropriate insulin adjustments based on glucose trend data.Abbreviations: A_1c = hemoglobin A_1c CGM = continuous glucose monitoring ROC = rate of change SMBG = self-monitored blood glucose     

Pragmatic Clinic-Based Investigation of Glycemic Variability in Patients With Type 1 Diabetes in Routine Clinical Practice and Its Association With Cardiovascular Autonomic Neuropathy: A Pilot Study

ObjectiveTo evaluate the relationship between markers of glycemic variability (GV), assessed by blinded continuous glucose monitoring (CGM), and cardiovascular autonomic neuropathy (CAN) in patients with type 1 diabetes (T1D).MethodsGV indices, such as SD and coefficient of variation were obtained by blinded CGM through an electrode inserted into the subcutaneous tissue for at least 3 consecutive days. CAN was assessed by cardiovascular reflex tests and HRV.ResultsFifteen T1D patients were included: 7 (46.7%) women, aged 47.1 ± 11.6 years, with a diabetes duration of 26 years (20 to 29.5 years). Five patients (25%) were excluded from our study. The majority of our patients presented glycated hemoglobin (60%), SD (86.3%), and coefficient of variation (60%) above the established goals. Patients with defined CAN had a longer diabetes duration, higher glycated hemoglobin levels, lower glomerular filtration rate, lower prevalence of indices related to hypoglycemic stress, and short-term GV indices compared with patients without CAN.ConclusionOur study showed an inverse association between GV and CAN. The most important risk factors associated with CAN were age, diabetes duration, and markers of chronic hyperglycemia. Furthermore, the difficulty in the interpretation of data extracted from the blinded CGM system, which also requires a minimum of 3 capillary blood glucose measurements for calibration, should be carefully analyzed to ensure the accuracy and usefulness of the blinded CGM system as a tool for diabetes management in developing countries. Further studies are necessary to establish the role of GV in the development of CAN in patients with T1D.     

A Retrospective Study Comparing Neutral Protamine Hagedorn Insulin With Glargine As Basal Therapy In Prednisone-Associated Diabetes Mellitus In Hospitalized Patients

ObjectiveTo compare glycemic outcomes in hospitalized patients with or without type 2 diabetes mellitus receiving neutral protamine Hagedorn insulin (NPH) vs glargine as basal insulin for management of glucocorticoid-associated hyperglycemia.MethodsWe conducted a retrospective review of electronic medical records in prednisone-treated adult patients with hyperglycemia in a university hospital. Consecutive patients were selected in both the NPH and glargine cohorts using inclusion and exclusion criteria. Baseline characteristics were assessed in each cohort. Glycemic outcomes were analyzed by comparing fasting blood glucose, mean daily blood glucose concentration, median daily blood glucose concentration, and the number of hypoglycemic episodes on a prespecified index day.ResultsOne hundred twenty patients were included: 60 patients in the NPH cohort and 60 patients in the glargine cohort. The weight-based insulin requirement was lower in the NPH cohort than in the glargine cohort (0.27 ± 0.2 units/kg vs 0.34 ± 0.2 units/kg [P = .04] for basal insulin and 0.26 ± 0.2 units/kg vs 0.36 ± 0.2 units/kg [P = .03] for bolus insulin). NPH and glargine cohorts were similar regarding age, sex, race, body mass index, hemoglobin A_1c, serum creatinine, and prednisone dosage. Glycemic outcomes in the NPH cohort compared with outcomes in the glargine cohort were similar regarding mean fasting blood glucose concentration (134 ± 49 mg/dL vs 139 ± 54 mg/dL [P = .63]), mean daily blood glucose (167 ± 46 mg/dL vs 165 ± 52 mg/dL [P = .79]), median blood glucose (160 ± 49 mg/dL vs 159 ± 57 mg/dL [P = .90]), and number of hypoglycemic episodes per day (0.12 ± 0.3 vs 0.10 ± 0.3 [P = .77]).ConclusionsNPH and glargine appear to be equally effective as basal insulin in the management of hyperglycemia in hospitalized patients receiving prednisone. However, the total daily insulin doses used were lower in the NPH cohort. (Endocr Pract. 2012;18:712-719)     

Markers for Risk of Type 1 Diabetes in Relatives of Alsacian Patients With Type 1 Diabetes

Background: The cytotoxic T lymphocyteassociated antigen 4 gene (CTLA-4) encode the T cell receptor involved in the control of T cell proliferation and mediates T cell apoptosis. The receptor protein is a specific T lymphocyte surface antigen that is detected on cells only after antigen presentation. Thus, CTLA-4 is directly involved in both immune and autoimmune responses and may be involved in the pathogenesis of multiple T cell-mediated autoimmune disorders. There is polymorphism at position 49 in exon 1 of the CTLA-4 gene, providing an A-G exchange. Moreover, we assessed the CTLA-4 49 (Thr/Ala) polymorphism in diabetic patients and first-degree relatives as compared to control subjects. Research design and methods: Three loci (HLA-DQB1, DQA1 and CTLA-4) were analysed in 62 type 1 diabetic patients, 72 firstdegree relatives and 84 nondiabetic control subjects by means of PCR-RFLP. Results: A significant enrichment in DQB1 alleles encoding for an amino acid different from Asp in position 57 (NA) and DQA1 alleles encoding for Arg in position 52 was observed in diabetic subjects and first-degree relatives as compared to controls. The genotype and allele frequencies of these polymorphisms in type 1 diabetic patients and firstdegree relatives differed significantly from those of controls (p< 0.001 and 0.05 respectively). CTLA-49 Ala alleles frequencies were 75.8% in type 1 diabetic patients and 68.1% in first-degree relatives in comparison to 35.7% in control subjects. The Ala/Ala genotype conferred a relative risk of 18.8 (p < 0.001). Conclusion: The CTLA-4 49 Ala allele confers an increased risk of type 1 diabetes, independent of age and HLA-DQ genetic markers.     

Prevalence of Type 2 Diabetes Mellitus In Patients With Primary Hyperparathyroidism

IntroductionTo determine the prevalence of type 2 diabetes mellitus (DM) in patients with primary hyperparathyroidism.MethodsPrevalence of type 2 DM in 609 patients with surgically verified primary hyperparathyroidism presenting between 1992 and 2003 in a tertiary care hospital setting was assessed retrospectively and compared with published data of type 2 DM prevalence in Michigan’s general population. Diagnosis of type 2 DM was made on the basis of documentation in the medical record of fasting or random blood glucose level thresholds according to the 1997 American Diabetes Association criteria, history of diabetes mellitus, or therapy with antidiabetic medications.ResultsThe crude prevalence rate of type 2 DM in patients with primary hyperparathyroidism was significantly higher than the prevalence in the Michigan general population (15.9% vs 7.8%, respectively; P < .001). However, this difference was not significant after age stratification except for the age group of 64 to 75 years. Because of the differential distribution of participants across age categories in the 2 groups, a standardized prevalence ratio (SPR) was estimated to account for the variance. After adjustment, there was no significant difference in the prevalence of DM between patients with primary hyperparathyroidism and the control population (SPR, 1.19 [95% confidence interval, 0.96-1.45]) except in men.ConclusionThe reported higher prevalence of type 2 DM in patients with primary hyperparathyroidism could not be confirmed in this large cohort of patients except for in older patients and in men. Because of the retrospective nature the study and the lack of appropriate controls, further studies are needed to confirm or refute these findings. (Endocr Pract. 2008;14:69-75)     

Continuous Subcutaneous Insulin Infusion (Insulin Pump) Therapy can be Safely Used in the Hospital in Select Patients

ObjectiveTo analyze data on inpatient insulin pump use and examine staff compliance with hospital procedures, glycemic control, and safety.MethodsWe conducted a retrospective review of charts and bedside glucose data for patients who had been receiving outpatient insulin pump therapy and were admitted to our teaching hospital between November 1, 2005, and February 8, 2008.ResultsDuring the study period, there were 50 hospitalizations involving 35 patients who had been receiving outpatient insulin pump therapy. The mean age and duration of diabetes of the 35 patients was 55 years and 32 years, respectively. Sixty-six percent were women, and 91% had type 1 diabetes. Patients in 31 of the hospitalizations (62%) were deemed candidates for continued insulin pump therapy during their stay. Of the 31 hospitalizations, 80% had the presence of the pump documented at admission; 100% had an admission glucose value; 77% had documentation of signed patient consent; 81% had evidence of completed preprinted insulin pump orders; 77% received an endocrine consultation; and 68% had a completed bedside flow sheet. Patients continuing insulin pump therapy had mean bedside glucose levels similar to those whose pump therapy was discontinued (P = .11); however, the proportion of hypoglycemic events was lower among insulin pump users (P < .01) than among nonusers.ConclusionsInsulin pump therapy is safe for select inpatients. Overall, staff compliance with procedures was high, although we identified areas for improvement. Continued study is needed on the effectiveness of insulin pump therapy in controlling inpatient hyperglycemia. (Endocr Pract. 2009;15:24-29)     

C-Peptide and Beta-Cell Autoantibody Testing Prior to Initiating Continuous Subcutaneous Insulin Infusion Pump Therapy Did Not Improve Utilization Or Medical Costs Among Older Adults With Diabetes Mellitus

Objective: To study the impact of the C-peptide and beta-cell autoantibody testing required by the Center for Medicare and Medicaid Services (CMS) on costs/utilization for patients with diabetes mellitus initiating continuous subcutaneous insulin infusion (CSII) therapy.Methods: This retrospective study used propensity score–matched patients. Analysis 1 compared patients 1-year pre- and 2-years post-CSII adoption who met or did not meet CMS criteria. Analysis 2 compared Medicare Advantage patients using CSII or multiple daily injections (MDI) who did not meet CMS criteria for 1-year pre- and 1-year post-CSII adoption. Analysis 3 extended analysis 2 to 2 years postindex and also included a subset of patients ≥55 years old but not yet in Medicare Advantage.Results: Analysis 1 resulted in significantly slower growth in hospital admissions (P =.0453) in CSII-treated patients who did not meet the criteria. Analyses 2 and 3 showed numerically slower growth in inpatient, outpatient, and emergency department (ED) costs for CSII versus MDI patients (both not meeting criteria). Analysis 3 showed significantly slower growth in ED costs and hospital admissions for CSII versus MDI Medicare Advantage patients before propensity matching (both P<.05). In patients ≥55 years old, ED costs grew more slowly for CSII than MDI therapy (P =.0678).Conclusion: Numerically slower growth in hospital admissions was seen for pump adopters who did not meet CMS C-peptide criteria, while medical costs growth was similar. For CSII users who did not meet the CMS criteria, numerically slower growth in inpatient, outpatient, ED costs, and hospital admissions occurred versus MDI.Abbreviations: CMS = Center for Medicare and Medicaid Services; CSII = continuous subcutaneous insulin infusion; DM = diabetes mellitus; DME = durable medical equipment; ED = emergency department; MDI = multiple daily injections (of insulin)     

Glucose-Reducing Effect of the ORMD-0801 Oral Insulin Preparation in Patients with Uncontrolled Type 1 Diabetes: A Pilot Study

The unpredictable behavior of uncontrolled type 1 diabetes often involves frequent swings in blood glucose levels that impact maintenance of a daily routine. An intensified insulin regimen is often unsuccessful, while other therapeutic options, such as amylin analog injections, use of continuous glucose sensors, and islet or pancreas transplantation are of limited clinical use. In efforts to provide patients with a more compliable treatment method, Oramed Pharmaceuticals tested the capacity of its oral insulin capsule (ORMD-0801, 8 mg insulin) in addressing this resistant clinical state. Eight Type I diabetes patients with uncontrolled diabetes (HbA1c: 7.5–10%) were monitored throughout the 15-day study period by means of a blind continuous glucose monitoring device. Baseline patient blood glucose behavior was monitored and recorded over a five-day pretreatment screening period. During the ensuing ten-day treatment phase, patients were asked to conduct themselves as usual and to self-administer an oral insulin capsule three times daily, just prior to meal intake. CGM data sufficient for pharmacodynamics analyses were obtained from 6 of the 8 subjects. Treatment with ORMD-0801 was associated with a significant 24.4% reduction in the frequencies of glucose readings >200 mg/dL (60.1±7.9% pretreatment vs. 45.4±4.9% during ORMD-0801 treatment; p = 0.023) and a significant mean 16.6% decrease in glucose area under the curve (AUC) (66055±5547 mg/dL/24 hours vs. 55060±3068 mg/dL/24 hours, p = 0.023), with a greater decrease during the early evening hours. In conclusion, ORMD-0801 oral insulin capsules in conjunction with subcutaneous insulin injections, well tolerated and effectively reduced glycemia throughout the day.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00867594","term_id":"NCT00867594"}}NCT00867594.     

Exenatide Therapy in Obese Patients With Type 2 Diabetes Mellitus Treated with Insulin

ObjectiveTo evaluate the effect of exenatide on clinical parameters in obese patients with type 2 diabetes mellitus whose hyperglycemia is not adequately controlled despite treatment with oral hypoglycemic agents and insulin.MethodsIn this retrospective analysis, clinical progress of 52 obese patients with type 2 diabetes treated with exenatide, 5 mcg twice daily, in an outpatient setting was reviewed. Treatment initiation was between September and December 2005. Mean follow-up period was 26 weeks. Thirty-eight patients took exenatide regularly (Group A); 14 patients discontinued exenatide because of insurance, personal, or economic reasons (Group B). Measurements at baseline and at follow-up included body weight; blood pressure; and levels of hemoglobin A_1c (HbA_1c), high-sensitivity C-reactive protein (CRP), and plasma lipids. Insulin dosage requirements were assessed.ResultsMean body weight (± standard error of the mean) decreased by 6.46 ± 0.8 kg (P < .001) in Group A and increased by 2.4 ± 0.6 kg in Group B (P < .001). In Group A, mean HbA_1c decreased by 0.6 ± 0.21% (P = .007), and the insulin dosage requirement decreased for rapid-acting and mixed insulins (P < .02). In Group A, means of the following parameters decreased: serum total cholesterol by 8.5 ± 3.3% (P = .03), triglycerides by 26 ± 7.6% (P = .01), systolic blood pressure by 9.2 ± 3.3 mm Hg (P = .02), and high-sensitivity CRP by 34 ± 14.3% (P = .05). These indices did not change in Group B.ConclusionExenatide effectively treats obese patients with type 2 diabetes on insulin, leading to weight loss and reduction in levels of HbA_lc, systolic blood pressure, triglycerides, and high-sensitivity CRP. (Endocr Pract 2007;13:444-450)     

Effects of Pramlintide in Patients with Type 2 Diabetes Mellitus: An Analysis Using Daily Insulin Dose Tertiles

ObjectiveThe purpose of the analysis was to investigate if the efficacy and tolerability of 6 months of pramlintide therapy in patients with type 2 diabetes mellitus (T2DM) differed with increasing levels of concomitant insulin doses, using data from 3 previously described clinical trials.MethodsIn this post hoc analysis, data from 2 pooled, placebo-controlled pivotal trials and 1 clinical practice trial were evaluated by baseline insulin use tertile in patients with T2DM.ResultsIn the pivotal trials, both glycated hemoglobin (A1C) and body weight decreased similarly across tertiles with pramlintide. A1C decreased slightly and body weight remained relatively unchanged across tertiles with placebo. Similarly, in the clinical practice trial, pramlintide was associated with decreases in A1C, body weight, and total daily insulin use across the tertiles. Overall, the most common adverse events were gastrointestinal in nature, and the rate of severe hypoglycemia was low.ConclusionThese results suggest that pramlintide therapy was associated with improved A1C and decreased body weight, with a low rate of severe hypoglycemia, among patients with T2DM, regardless of baseline insulin use. (Endocr Pract. 2014;20:1070-1075)