bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of Insulin Regimen and Glycemic Control in Noncritically Ill Hospitalized Patients with Type 2 Diabetes Receiving Continuous Enteral Nutrition Therapy
Authors: SELEN DARYL J. , HOWARD ALAN B. , GILBERT MATTHEW P. 
Published: June 2018

Hyperglycemia is a common complication in hospitalized patients with type 2 diabetes mellitus (T2DM) on continuous enteral nutrition therapy (ENT). The purpose of this study was to identify an insulin regimen for this patient population that provided adequate coverage for hyperglycemia without significant hypoglycemia. A retrospective chart review was conducted at the University of Vermont Medical Center for noncritically ill patients admitted between 07/01/2012 and 09/01/2015 who had T2DM and received continuous ENT for ≥72 hours—209 patients met the inclusion criteria; 117 had received aspart sliding scale only and 92 had received aspart with long-acting glargine. Our results revealed no evidence of severe hypoglycemia (blood glucose &lt;40mg/dL) in either group, and the occurrence of hypoglycemia (blood glucose &lt;70mg/dL) was similar in both groups (p=0.54). However, there was a difference in the percentage of blood glucose values within the optimal range (100 to 180mg/dL): the aspart-only group had 60.3%±27.2% of values within this range compared to 36.6%±24.4% in the aspart+glargine group (p&lt;0.001). The aspart+glargine group had blood glucose levels &gt;180 mg/dL 58.8%±26.9% of the time compared to 33.1%±28.6% in the aspart-only group (p&lt;0.0001).
In conclusion, both insulin regimens resulted in similar efficacy in noncritically ill, hospitalized patients with T2DM receiving continuous ENT without significant hypoglycemia. However, neither regimen resulted in blood glucose values in the optimal range for a sufficient percentage of the 72-hour period. A basal and bolus insulin regimen, rather than sliding scale only, is likely needed to improve overall glycemic control in these patients while preventing hypoglycemia. Further prospective studies are needed in this area to identify the most appropriate insulin program to treat hyperglycemia in hospitalized patients on ENT.

Disclosure
D.J. Selen: Employee; Spouse/Partner; CVS/Caremark. A.B. Howard: None. M.P. Gilbert: Consultant; Self; Sanofi US, Novo Nordisk A/S.
Use of Insulin Degludec in Type 1 Diabetes Clinical Practice in the U.K.—General Practice Data from Two English Regions and Data from the Association of British Clinical Diabetologists (ABCD) Nationwide Degludec Audit
Authors: LUMB ALISTAIR N. , GALLEN IAN W. , BICKERTON ALEX , ABRAHAM RALPH R. , BAIN STEPHEN C. , HARPER ROY , RYDER ROBERT E. ,   ABCD NATIONWIDE DEGLUDEC AUDIT CONTRIBUTORS
Published: June 2018

In clinical trials insulin degludec (Tresiba) was associated with less hypoglycaemia and less day to day glucose variability than older basal insulins. This study assessed the use of insulin degludec in type 1 diabetes in real clinical practice in the UK.
Data were extracted from General Practice records in 2 areas of England for people with type 1 diabetes, prescribed insulin degludec, who had weight and HbA1c measurements at baseline and at least 3 months into treatment. 77 eligible people were identified (43M, 44F). Mean age was 53.3 years (SD 19.9). In this unselected group, there was a significant reduction in HbA1c from 9.5% to 8.9% (p&lt;.001), associated with a significant rise in weight from 78.4 to 80.7kg (P&lt;.005). For individuals, there was no significant association between the change in HbA1c and change in weight.
These data were considered alongside data from the ABCD Nationwide Degludec Audit. In this audit, there were 144 people with type 1 diabetes who had weight and HbA1c measurements at baseline and at least 3 months into treatment at the time of the analysis (65M, 79F). Mean age was 44.1 years (SD 15.7). There was no significant reduction in HbA1c with degludec treatment (8.9% to 8.7%), and no significant increase in weight (77.2 to 77.7 kg).
We have previously shown in the ABCD Nationwide Degludec Audit that there is no significant change in HbA1c or weight in those switched to insulin degludec for reasons of hypoglycaemia (n=88), although hypoglycaemia is significantly improved. A significant reduction in HbA1c and significant increase in weight is seen in those switched to insulin degludec for reasons other than hypoglycaemia (n=56). If the majority of those in the General Practice database were switched to degludec for reasons other than hypoglycaemia, such as to reduce day to day glucose variability, this may explain the observed results.

Disclosure
A.N. Lumb: Other Relationship; Self; Novo Nordisk A/S, Abbott. Consultant; Self; Johnson & Johnson Services, Inc.. I.W. Gallen: None. A. Bickerton: Other Relationship; Self; Novo Nordisk A/S. Advisory Panel; Self; Amgen Inc. R.R. Abraham: Advisory Panel; Self; Novo Nordisk Inc. S.C. Bain: Research Support; Self; Novo Nordisk Inc., AstraZeneca. R. Harper: None. R.E. Ryder: Other Relationship; Self; AstraZeneca. Speaker's Bureau; Self; Bioquest, Janssen Pharmaceuticals, Inc.. Other Relationship; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Novo Nordisk A/S.
Efficacy of a Basal-Plus Regimen
Authors: SABOO BANSHI D.J. , HASNANI DHRUVI , CHANDARANA HARDIK , BHANDARI SUDHIR , JOSHI SHASHANK , KESAVADEV JOTHYDEV , MAHESHWARI ANUJ , THACKER HEMANT 
Published: June 2018

Aim: To find out Efficacy of a basal plus regimen.
Objectives: 1. To find out the efficacy of basal plus regime by evaluating the changes in HbA1c at 24 weeks. 2. To find out changes in weight and frequency of hypoglycemia after initiation of the basal plus regime.
Method: The study was a prospective analysis of 24 weeks after initiation of basal plus regime. Inclusion criteria: T2DM&gt;5 Years; On 3OAD + basal insulin, HbA1c- 7.5-8.5%. Exclusion Criteria: critically ill patients, acute infection, pregnant, T1D. All patients matching the inclusion criteria were analyzed on the basis of SMBG chart to find out their highest glycemic excursion of post prandial and fasting readings. Based on the diet recall and sugar reading charts these patients were initiated on bolus insulin with the largest meal of the day where their post prandial corresponded to the highest reading. They were educated on proper insulin injection techniques and SMBG and asked to follow-up with their sugar readings using telemedicine application every day.
Result: We studied 220 patients (F=124 M=96) with HbA1c at baseline 7.5-8.5% (avg-8.0). After addition of bolus insulin at 12 weeks target HbA1c &lt;7% was achieved in 55.9% (n=123) patients with minor dose titrations. Average HbA1c at 12 Weeks was 7.3%. At 24Weeks target HbA1c was achieved in 88.18% (n=194) of patients after uptitration of bolus dose. Average HbA1c at 24Weeks was 6.9%. 5 patients experienced severe hypoglycemic episode. Cases of 15 average mild to moderate hypoglycemic episodes were reported. Regular SMBG and follow-up of the patients through telemedicine applications is continued for insulin dose titration. Fasting sugar target of below 110 mg/dl was achieved through titration of basal insulin in all 220 patients at the end of 12 weeks. Post prandial glycemic readings at the end of 12 weeks were achieved below 160 mg/dl in 167 patients and at 24 weeks in 198 patients.
Conclusion: After failure of OADS and basal insulin a basal plus regime with addition of 1 bolus insulin with the largest meal of the day helped achieve the target HbA1c of &lt;7% effectively.

Disclosure
B.D.J. Saboo: None. D. Hasnani: None. H. Chandarana: None. S. Bhandari: None. S. Joshi: None. J. Kesavadev: Advisory Panel; Self; Novo Nordisk India Private Limited. Speaker's Bureau; Self; Novo Nordisk India Private Limited. Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; MSD. Speaker's Bureau; Self; MSD. Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. A. Maheshwari: None. H. Thacker: Research Support; Self; Wockhardt LTD.
Insulin Initiation and Concomitant OHA (Oral Hypoglycaemic Agents) in Treatment of Diabetes Mellitus—Results of the Indian Human Insulin Registry (INHIRIT)
Authors: KARADI VEERANNA , PAWAR DILIP , JABEEN SARAH , S. SANDEEP , BOSE SAPTARSHI , WAGH SAGAR P. , BHATTACHARJEE KINGSHUK , ANAND SANTOSH 
Published: June 2018

INHIRIT is a multi-centric, prospective, open-label, single-arm, observational, naturalistic registry of diabetes mellitus patients in India with the aim of understanding the criteria for insulins initiation in day to day practice. Patients initiated on human insulin were included in the registry during which their glycaemic parameters and body weight was monitored. The commonly used oral antidiabetic drugs (OADs) used along with insulin therapy and the relevance of BMI as a criterion for insulin selection also was evaluated.
Results: Of the total 668 patients with insulin initiation data, 62 were treatment-naïve. The mean total daily dose of insulin was 36.8 units/d. The daily insulin dose was higher for HbA1C between 7%-8% (42.03 units/d). The most commonly used OADs with insulin were the DPP-4 inhibitors (59.3%), sulfonylureas (50.6%) and metformin (42.7%). Other OADs used are alpha-glucosidase inhibitors (8.5%), thiazolidinedione’s (7.9%), SGLT inhibitors (1.3%) and other OADs (0.4%). Sulfonylureas used in the decreasing order glimepiride, gliclazide, glimepiride, glibenclamide and glipizide. Voglibose was the widely used alpha-glucosidase inhibitor and dapagliflozin was the commonly used SGLT inhibitor. There was found to be no preference of insulin type in underweight patients. However, more overweight and obese patients received human premix 30/70 compared to other insulin preparations.
Conclusion: Our study illustrated the roles that different antidiabetic drugs play in the management of diabetes; chief among them was DPP-4 inhibitors, which represents almost 60% of prescriptions overlapping with insulin and the percentage use of sulfonylurea has decreased.

Disclosure
V. Karadi: None. D. Pawar: Employee; Self; Biocon. S. Jabeen: Employee; Self; Biocon. S. S.: Employee; Self; Biocon. S. Bose: Employee; Self; Biocon. S.P. Wagh: None. K. Bhattacharjee: Employee; Self; Biocon. S. Anand: None.
GLP Analogues Are Superior for Diabetes and Weight Control in Patients on Antipsychotic Plus/Minus Antidepressant Medications
Authors: PERLIS LAUREN , MIEDLICH SUSANNE U. 
Published: June 2018

Obesity and diabetes are much more common in patients with mental illnesses compared to the general population and they are linked to adverse cardiovascular (CV) outcomes. Antipsychotic, but also antidepressant medications have been associated with adverse metabolic outcomes. Newer diabetes medications, for example GLP (Glucagon-Like Peptide) analogues, improve not only diabetes control, they also promote weight loss and some (f.i. liraglutide) lower adverse CV outcomes making them ideal agents for mentally diseased patients. Studies of these at-risk patients are scarce and inconclusive. While one study of prediabetic patients on antipsychotics showed improved glucose tolerance and weight loss on a GLP analogue [liraglutide (Larsen JR et al., 2017)], another did not [exenatide (Ishoy PL et al., 2017)]. We thus analyzed diabetic patients on antipsychotics after referral to our diabetes clinic between 2010-2016. Forty five patients were included in this retrospective study; ten were started on GLP analogues (cases), thirty five were treated with alternative diabetic agents (controls). Cases and controls did not significantly differ in age, sex, height, weight and medical therapies at the time of referral. Within one year, a significant reduction in HbA1c (mean±SE) was noted in both groups (-1.25±0.25% for cases, -1.47±0.45% for controls). However, patients on GLP analogues lost 7.1±2.6kg, whereas control patients gained 1.9±1.4kg (p=0.005). Within the entire cohort, we also noted a blunted HbA1c reduction in patients on antidepressants (-0.69±0.33% ON, -2.97±0.6% OFF antidepressants, p=0.001). The opposite trend was observed for patients on GLP analogues, a greater HbA1c reduction was seen for those ON antidepressants.
In summary, GLP analogues are superior for both diabetes and weight control in diabetic patients on antipsychotics plus/minus antidepressants. Future studies are needed to confirm and validate these promising trends.

Disclosure
L. Perlis: None. S.U. Miedlich: None.
Persistence to Liraglutide Therapy Is Associated with Good Glycemic and Body Weight Control in Patients with Type 2 Diabetes
Authors: COHEN CHELI MELZER , CHODICK GABRIEL , HUSEMOEN LISE LOTTE N. , RHEE NICOLAI , SHALEV VARDA , KARASIK AVRAHAM 
Published: June 2018

Objective: In both randomized, controlled trials and real-world studies, liraglutide (Victoza®) has demonstrated glycemic and body weight benefits in patients with type 2 diabetes mellitus (T2DM). To achieve long-term beneficial outcomes, persistence with treatment is important; however, this can be challenging with injectable drugs. In this study, we examined the association of long-term adherence to liraglutide and metabolic changes.
Methods: A retrospective analysis of patients with T2DM (≥18 years old) from Maccabi Healthcare Services, Israel, who initiated liraglutide from 2010-2015 and had HbA1c measurements at treatment initiation and after 24 months. Mean change in HbA1c and body weight from initiation to 24 months was compared between patients who received liraglutide regularly for at least 12 months (’continuers’) and those who discontinued liraglutide before 12 months (’discontinuers’). Patients who were treated with another GLP-1 receptor agonist, or who underwent bariatric surgery, were excluded. Adjustment for potential confounding factors (sex, age, years in diabetes registry, HbA1c, body mass index, and insulin use at treatment start) was performed using propensity score matching (1:1 [n=882 in each group]).
Results: Significant reductions in HbA1c were seen in continuers compared with discontinuers (0.80% vs. 0.32%, p&lt;0.0001), despite more using insulin (70.2% vs. 59.0%, p&lt;0.0001) and ≥3 oral antihyperglycemic drugs (20.6% vs. 6.2%, p&lt;0.0001) among discontinuers (in the 3 months preceding the last measurement). Mean body weight reduction was higher in continuers than in discontinuers (3.57 kg vs. 1.25 kg; p&lt;0.0001), but no statistically significant differences were observed in low-density lipoprotein cholesterol (5.72 vs. 2.83 mg/dl [p=0.4717]) and triglycerides (10.37 vs. 6.89 mg/dl [p=0.7896]).
Conclusion: In a real-world setting, persistent use of liraglutide was associated with good glycemic and body weight control.

Disclosure
C. Melzer Cohen: None. G. Chodick: None. L.N. Husemoen: Employee; Self; Novo Nordisk A/S. N. Rhee: Employee; Self; Novo Nordisk A/S. V. Shalev: None. A. Karasik: Stock/Shareholder; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Advisory Panel; Self; Novo Nordisk A/S, AstraZeneca. Research Support; Self; AstraZeneca. Consultant; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Merck & Co., Inc., GlucoMe.
Liraglutide-Based Therapy Shows More Prominent Effect than Conventional Insulin Therapy to Achieve HbA1c Target, Especially in Patients with Short Duration
Authors: KASHIMA KOJI , SHIMIZU HIROYUKI , YAMADA MASANOBU 
Published: June 2018

Objective: Despite advanced new medications, the rate of achieving HbA1c target &lt;7% is only around 50%. The aim of study is to evaluate the ability of GLP-1 receptor agonist to achieve this target compared to insulin therapy.
Methods: A total of 154 type 2 diabetic (T2DM) patients on liraglutide (LIRA) based therapy and 124 T2DM patients on insulin based therapy were randomly recruited. The rate of patients achieving the target and background characteristics were compared.
Results: 1) The rate of achieving HbA1c&lt;7% was 41.6% on insulin vs. 61.0% on LIRA. HbA1c&lt;6% was only 7.3% on insulin, but 19.4% on LIRA, although self-blood glucose monitoring (SMBG) was equally done (52.4% vs. 51.9%). 2) Divided into 3 regimes: LIRA mono-injection, LIRA+basal insulin, LIRA+basal bolus (BBT)/pre-mixed insulin therapy, achieving HbA1c&lt;7% rate much varied: 76.3%, 56.9%, and 35.0%. Achieving HbA1c&lt;6% rate was 21.8%, 21.5%, and 5.0% without hypoglycemia. In mono-injection group, the rate of SMBG (30.9%) was lower than other 2 groups (58.2%, 80.0%), and less cost. Moreover, prominent effect was attained in this group, HbA1c improved from 9.9±2.9 to 6.6±0.9% (p&lt;0.01), and BMI improved from 24.5±5.9 to 23.6±5.3kg/m2 (p&lt;0.05) by adding LIRA. In background characteristics, the duration of diabetes was shortest (6.6±6.3 year) in this group, compared with LIRA+basal (11.2±8.8 year) or LIRA+BBT/pre-mixed (15.6±10.6 year) group. But ischemic heart disease (12.7%), chronic kidney disease (30.9%), and obesity (30.9%) complication rates were still high. 4) In one of the patients with a year duration of diabetes, after changing the regime from BBT into LIRA+basal insulin, marked improvement in HbA1c from 8.2% to 5.6% with narrowing blood glucose range 126∼349mg/dL into 79∼145mg/dL was found, and durability for 3 years was confirmed.
Conclusion: Since T2DM is a complex metabolic disorder, LIRA should be started early years to get its maximum benefit of LIRA.

Disclosure
K. Kashima: None. H. Shimizu: Speaker's Bureau; Self; Eli Lilly and Company, MSD K.K., Daiichi Sankyo Company, Limited, Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk Inc.. M. Yamada: None.
Gut Microbiome Dysbiosis and Increased Intestinal Permeability in Australian Children with Islet Autoimmunity and Type 1 Diabetes
Authors: HARBISON JESSICA E. , ROTH-SCHULZE ALEXANDRA J. , BARRY SIMON C. , TRAN CUONG D. , NGUI KATRINA , PENNO MEGAN A. , WENTWORTH JOHN , COLMAN PETER G. , THOMSON REBECCA , CRAIG MARIA E. , PAPENFUSS ANTHONY T. , GILES LYNNE , HARRISON LEONARD C. , COUPER JENNY 
Published: June 2018

We aimed to characterise the gut microbiome and small intestinal permeability in children with islet autoimmunity and type 1 diabetes (T1D). 88 participants, median age 11.8 (IQR 8.1-13.3) years at baseline were followed 6 monthly for a median of 13 months (range 2-34). 18 had islet autoimmunity, 29 recent-onset T1D, and 41 were age and gender-matched unrelated or sibling controls. Stool samples were collected (Omnigene kit) for 16S rRNA gene sequencing. Small intestinal permeability was measured by blood lactulose:rhamnose ratio (L/R), 90 minutes after drinking a 5gm lactulose/1gm rhamnose solution. Antibodies to insulin, GAD, IA2 and ZnT8 were assayed using IASP standardized radiobinding assays. Statistical analysis used linear mixed models. Differential abundance analysis used limma with total-sum scaling.
Children with islet autoimmunity or T1D had gut microbiome dysbiosis with reduced α diversity and different β diversity compared with controls. Progressors from islet autoimmunity to T1D had lower observed richness (OTUs) (p=0.01) and different β diversity (Adonis, P=0.004), compared with non-progressors. Genus Prevotella, with anti-inflammatory properties, was less abundant in children with T1D (p&lt;0.005) or ≥ 2 islet antibodies (p&lt;0.005) than in controls. Diet did not explain this difference. L/R was higher in T1D than sibling controls (mean difference +3.03±1.02, p=0.003). Progressors had higher L/R than non-progressors (+4.74±1.97, p=0.01) and sibling controls (+4.62±1.69, p=0.006). There was a trend towards a relationship between higher L/R and lower observed richness in the microbiome over time in children with ≥ 2 islet antibodies or T1D (coeff -0.0617, 95% CI -0.1254, 0.002 P=0.058).
Australian children progressing from islet autoimmunity to T1D have gut dysbiosis and increased intestinal permeability. This observation supports a mechanism underlying progression to T1D.

Disclosure
J.E. Harbison: None. A.J. Roth-Schulze: None. S.C. Barry: None. C.D. Tran: None. K. Ngui: None. M.A. Penno: None. J. Wentworth: None. P.G. Colman: None. R. Thomson: None. M.E. Craig: None. A.T. Papenfuss: None. L. Giles: None. L.C. Harrison: None. J. Couper: None.
DPP-4 Inhibitor Gemigliptin in T2DM Patients Uncontrolled on Metformin—Results of Multicenter, National, Randomized, Parallel-Group, Phase 3 Study Alternative
Authors: BIRUKOVA ELENA 
Published: June 2018

Gemigliptin a new DPP-4 inhibitor is marketed in Korea since 2012. The study compared the efficacy and safety of gemigliptin (G) 50mg QD vs. vildagliptin (V) 50mg BID as add-on therapy to metformin in type 2 diabetes mellitus Russian patients (pts) uncontrolled on metformin. This was a multicenter comparative randomized (1:1) open-label 24- week non-inferiority trial (predefined equivalence limit difference = 0, 4). Pts with 7% &lt; HbA1c &lt; 9.5% and metformin ≥ 1500mg entered into the study. Change in HbA1c from baseline at 24 weeks was the primary endpoint. Distribution of study populations: randomized-443, of whom G-group-220 (PP population-180), V-group-223 (PP population-196).
Results: Baseline characteristics were comparable between the 2-treatment groups except for BMI in G-treatment group (32.72±4.35 vs. 31.88±3.93 kg/m2, p&lt;0.05). Mean HbA1c change at 24 weeks was -0.77±1.17% for G and -0.79±1.11% for V groups. Between-groups mean difference of HbA1c changes was 0.22% [95% CI 0, 15-0, 29] confirming non-inferiority of G effect vs. V (p&lt;0,001). The 7-points self-monitoring of glucose changes from week 0 to 24 (n=117 for G, n=118 for V): significant glucose level reduction before and 2 hours after dinner was reported in G-group only, but 2 hours after lunch in V-group only*. Eleven cases of symptomatic hypoglycemia were reported in 7 (1.58%) pts: 5 cases in 3 (1, 4%) pts in G-group and 6 cases in 4 pts (1, 8%) in V-group*. No cases of severe or asymptomatic hypoglycemia were reported. 64 AEs including 4 SAEs were reported in 49 pts (11, 1%). 34 (53, 1%) AEs were reported in G-group and 30 AEs in V-group (46, 9%)*.
Conclusion: The clinical efficacy of gemigliptin 50mg was similar to that of vildagliptin 100mg. Both gemigliptin and vildagliptin were well tolerated and did not expose patients to severe hypoglycemias. *- between treatment groups was not statistically significant.

Disclosure
E. Birukova: None.