bluuebunny/crossref_metadata_2025_split huggingface dataset:
1020-P: Effects of Insulin Degludec and Insulin Glargine U300 on Interday Glycemic Variability in Individuals with Type 1 Diabetes: A Multicenter, Randomized, Crossover Study
Authors: MIURA HIROSHI , SAKAGUCHI KAZUHIKO , KANEKO AKIHIRO , ITO JUN , MORITA YASUKO , YAMADA TOMOKO , OTOWA-SUEMATSU NATSU , SO ANNA , NAKAMURA TOMOAKI , KOMADA HISAKO , OKADA YUKO , HIROTA YUSHI , TAMORI YOSHIKAZU , OGAWA WATARU 
Published: June 2020

Background: Insulin degludec (IDeg) and insulin glargine U300 (IGla-300) are recently launched ultra-long-acting insulin formulations. It remains unclear whether or how their glucose-stabilizing effects differ. We now compared the effects of these insulins on parameters on glycemic variability in patients with type 1 diabetes (T1D).
Methods: This multicenter, randomized, crossover, non-inferiority trial recruited 46 patients with T1D treated with basal-bolus insulin therapy at 14 facilities in Japan. Patients were randomly assigned 1:1 to IGla-300 (first period)/IDeg (second period) or IDeg (first period)/IGla-300 (second period) groups, in which subjects were treated with the corresponding basal insulin for 4-week periods. The last week of each treatment period constituted the data collection phase, during which the participants determined the plasma glucose level seven times a day using a SMBG devise and were also equipped with a CGM devise. The primary end point was comparison of day-to-day glycemic variability evaluated by the standard deviation (SD) of FPG during the last week of each treatment period.
Results: The SD for FPG in the IDeg treatment period was not inferior to that in the IGla-300 treatment period (95% CI, -16.1-3.0 mg/dL). The levels (95% CI, -18.4-5.7 mg/dL) and the coefficient of variance (95% CI, -4.6-4.3 %) of FPG did not significantly differ between the two periods. Parameters obtained with CGM, including time-in-range, duration of nocturnal hypoglycemia, mean amplitude of glycemic excursion, and mean of the daily differences, as well as the doses of basal and bolus insulins also did not significantly differ between the two treatment periods.
Conclusion: IDeg was not inferior to IGla-300 in terms of inter-day glycemic variability in the treatment of T1D, and the treatments with these two insulins yielded similar outcomes for various parameters related to blood glucose control.

Disclosure
H. Miura: None. K. Sakaguchi: Other Relationship; Self; AstraZeneca, Novartis AG, Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi, Sanwa Kagaku Kenkyusho, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited. A. Kaneko: None. J. Ito: None. Y. Morita: None. T. Yamada: None. N. Otowa-Suematsu: None. A. So: None. T. Nakamura: None. H. Komada: None. Y. Okada: None. Y. Hirota: Other Relationship; Self; Sanofi. Y. Tamori: None. W. Ogawa: Research Support; Self; Astellas Pharma Inc., Boehringer Ingelheim Pharma GmbH & Co.KG, Eli Lilly Japan K.K., Kowa Company, Ltd., Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd. Other Relationship; Self; Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited.
1024-P: Technosphere Insulin Added to Basal Insulin Is Associated with Less Weight Gain than Basal Insulin plus Insulin Aspart or Insulin Analog (Aspart) 70/30 Mixture in Type 2 DM
Authors: MANOUKIAN JONATHAN , KENDALL DAVID M. , MOREY PATRICK M. , HOOGWERF BYRON J. 
Published: June 2020

Technosphere Insulin (TI) is a dry-powder formulation of recombinant human insulin adsorbed onto Technosphere microparticles for oral inhalation. Data from two 52-wk randomized phase 3 trials in type 2 DM were combined to analyze the effects of TI on body weight. In one trial, patients on basal insulin were randomized to prandial TI or insulin aspart. In the other trial, basal insulin plus prandial TI was compared to 70/30 insulin analog mixture. Primary efficacy end point in each trial was change in A1C. Weight data were captured in each study. Weight and A1C data were analyzed based on modified Intention to Treat Analyses and LS mean changes from baseline. In these analyses, the TI arms were combined and comparisons were made between TI and each of the comparator arms. Aspart and 70/30 arms were not compared to each other. Data for 26 and 52 wk time points are reported. Results At both 26 and 52 weeks, TI was associated with less weight gain than either aspart or premixed insulin. Differences were significant for TI vs. each comparator. A1C differences among treatment arms were small and only statistically significant for TI vs. aspart at 52 weeks.
Conclusion: In insulin treated T2DM persons, TI is associated with less weight gain than Insulin aspart or premixed 70/30 analog insulin. These weight differences appear to be independent of changes in A1C.

Disclosure
J. Manoukian: Employee; Self; MannKind Corporation. D.M. Kendall: Employee; Self; MannKind Corporation. Stock/Shareholder; Self; Eli Lilly and Company. P.M. Morey: Employee; Self; MannKind Corporation. B.J. Hoogwerf: Consultant; Self; MannKind Corporation. Employee; Spouse/Partner; MannKind Corporation. Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.
1029-P: Effectiveness of Premix Insulin (Premix) in Type 2 Diabetes (T2D): A Retrospective UK Cohort Study
Authors: JUDE EDWARD B. , ALI AMAR , EMRAL RIFAT , NANDA NITHYA , LUBWAMA ROBERT , PALMER KAREN D. , SHAUNIK ALKA , RASKIN PHILIP , GOMEZ-PERALTA FERNANDO , TRESCOLI CARLOS 
Published: June 2020

NICE guidelines suggest premix as a treatment option for people with T2D with HbA1c ≥9 % uncontrolled by ≥2 oral antidiabetic drugs (OADs). This retrospective cohort study explored real-world evidence for glycemic control with premix. UK electronic medical record data from THIN database were captured for adults with T2D uncontrolled (HbA1c ≥9 %) on ≥2 OADs initiating premix (index date) from 1/1/2010 to 12/31/2016. Baseline data were collected 12 months pre-index and outcomes followed for 24 months. Glycemic control was assessed by time to first achievement of HbA1c target &lt;7.5 % and change in HbA1c over time, and evaluated by baseline characteristics. The final cohort had 974 participants (mean age 62 years; 56% male; mean BMI 31 kg/m2; 27% overweight; 44% obese; 8% Class III obese; mean HbA1c 11.3 %). Common comorbidities were hypertension (64%), dyslipidemia (23%) and nephropathy (21%). Background medication included metformin (99%), DPP-4i (51%), TZD (42%), SU (19%) and SGLT2i (0.5%). Probability of first achievement of HbA1c target &lt;7.5 % was highest at 3-6 months (18%), 14% at 6-9 months, 15% at 9-12 months, and lower from 12 to 24 months (Figure). Target achievement differed by baseline HbA1c, but not OAD use. Probability of achieving glycemic targets on premix at 6 months was low, with little additional clinical benefit beyond 12 months, suggesting a high unmet need for early and timely therapy intensification.

Disclosure
E.B. Jude: Speaker’s Bureau; Self; AstraZeneca, Novo Nordisk Inc., Sanofi. Other Relationship; Self; Lilly Diabetes, Menarini Group. A. Ali: Advisory Panel; Self; Eli Lilly and Company, Napp Pharmaceuticals, Novo Nordisk A/S, Sanofi. Research Support; Self; Eli Lilly and Company, Gelesis. Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Stock/Shareholder; Self; Amarin Corporation. R. Emral: Advisory Panel; Self; Lilly Diabetes, Merck Sharp & Dohme Corp. Speaker’s Bureau; Self; AstraZeneca, Novo Nordisk Inc., Sanofi-Aventis. N. Nanda: Advisory Panel; Self; Novartis AG. Speaker’s Bureau; Self; AstraZeneca, Novo Nordisk Inc., Pfizer Inc., Sanofi. R. Lubwama: Employee; Self; Sanofi US. K.D. Palmer: Employee; Self; Sanofi. A. Shaunik: None. P. Raskin: None. F. Gomez-Peralta: Advisory Panel; Self; Abbott, Menarini Group, Novartis AG, Sanofi. Speaker’s Bureau; Self; Abbott, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novartis AG, Novo Nordisk A/S, Sanofi. C. Trescoli: None.

Funding
Sanofi
103-LB: Individual Glycemic Response to Faster Aspart Delivered by the Ilet Bionic Pancreas with Non-default vs. Default Tmax Settings
Authors: CASTELLANOS LUZ E. , ZHENG HUI , BALLIRO COURTNEY A. , SHERWOOD JORDAN , EKELUND MAGNUS , EL-KHATIB FIRAS , DAMIANO EDWARD , RUSSELL STEVEN J. 
Published: June 2020

We examined automated glycemic control with the insulin-only configuration of the iLet® bionic pancreas using faster aspart (Fiasp), comparing non-default tmax settings of the iLet® to a default tmax setting in a two-period, random-order cross-over design within each of three cohorts with eight different participants. Each participant was randomized to use the default tmax setting (t65 minutes) followed by the non-default tmax setting (t50, t40, or t30 minutes in cohorts 1, 2, and 3, respectively), or vice versa, for one week each. The group mean CGM glucose (CGMG) was significantly lower (two-sided p-value &lt;0.05) in the t50 versus t65 arm (-7.4 [-12.3; -2.4] mg/dl, p=0.011; 150.3 versus 157.7 mg/dl) and in the t40 versus t65 arm (-7.5 [-12.9; -2.1] mg/dl, p=0.015; 150.1 versus 157.6 mg/dl), but was not significantly different in the t30 versus t65 arm (-7.7 [-16.8; 1.4] mg/dl, 144.2 versus 151.9 mg/dl). Group mean time &lt;54 mg/dl was not significantly different between non-default and default tmax settings in all three cohorts, (+0.09%, +0.18%, and +0.17% in cohorts 1, 2, and 3, respectively, all p&gt;0.05). Using an autoregressive time series model, we determined the intra-individual statistical significance of differences in mean CGMG and time &lt;54 mg/dl between non-default and default tmax settings. The mean CGMG was significantly different for four of eight subjects in the t50 versus t65 cohort (mean -13±7 mg/dl), seven of eight subjects in the t40 versus t65 cohort (mean -8±8 mg/dl), and five of eight subjects in the t30 versus t65 cohort (mean -12±6 mg/dl). One subject had a significant change in time &lt;54 mg/dl (+1.2% of time; 1.2% versus 0%) in the t40 versus t65 arm. The majority of subjects had a significant reduction in mean CGMG with a non-default tmax setting while using Fiasp in the iLet. Use of different tmax settings could translate to clinically significant reductions in mean CGMG for many patients, with low risk of a significant increase in hypoglycemia.

Disclosure
L.E. Castellanos: None. H. Zheng: None. C.A. Balliro: None. J. Sherwood: None. M. Ekelund: Employee; Self; Novo Nordisk. Stock/Shareholder; Self; Novo Nordisk. Stock/Shareholder; Spouse/Partner; Novo Nordisk. F. El-Khatib: Other Relationship; Self; Beta Bionics, Inc. E. Damiano: Board Member; Self; Beta Bionics, Inc. Employee; Self; Beta Bionics, Inc. Stock/Shareholder; Self; Beta Bionics, Inc. Stock/Shareholder; Spouse/Partner; Beta Bionics, Inc. S.J. Russell: Consultant; Self; Beta Bionics, Inc., ConvaTec Inc., Novo Nordisk A/S, Senseonics. Research Support; Self; Beta Bionics, Inc., Novo Nordisk A/S, Zealand Pharma A/S. Stock/Shareholder; Self; Companion Medical. Other Relationship; Self; Ascensia Diabetes Care, Roche Diabetes Care.
1030-P: Self-Adjusting Subcutaneous Insulin Algorithm (SQIA) for Patients NPO or on TPN or Enteral Feedings
Authors: RUSHAKOFF ROBERT J. , ROV-IKPAH ESTHER , LUIS CRAIG SAN , JOHNSON CRAIG , PATZEK SOPHIE , JUTTUKONDA VENKATESWARLU , MACMASTER HEIDEMARIE W. 
Published: June 2020

We programmed a SQIA in the EMR. It requires the nurse to enter current glucose in the MAR, and then the calculated dose is shown. New dose is based on previous dose, and current and previous glucoses. The SQIA titrates the glucose to 120 -180 mg/dl for patients who are NPO, on TPN or Enteral Feedings (TF). No new orders are required even if insulin is added to TPN, or changes made in TF rates. Glucose and insulin data are shown in the table. The higher glucoses were at titration initiation. Two examples of how the titration worked are shown. Individual data demonstrate ability of the SQIA to titrate insulin and maintain glucoses in range despite significant changes to the rate of TF or addition of basal insulin as shown in Patient B. An automated SQIA allows insulin doses to be adjusted to the individual patient’s needs and maintain glucoses in range.

Disclosure
R.J. Rushakoff: None. E. Rov-Ikpah: None. C. San Luis: None. C. Johnson: None. S. Patzek: None. V. Juttukonda: None. H.W. Macmaster: None.
1033-P: Trends in U.S. Insulin Use for People with Diabetes: 2009-2017
Authors: PEREZ-NIEVES MAGALY , JUNEJA RATTAN , FAN LUDI , MEADOWS ERIC , LAGE MAUREEN J. , EBY ELIZABETH L. 
Published: June 2020

Objective: Examine trends of insulin regimens, delivery devices and glucose monitoring among people with type 1 diabetes (T1D) or type 2 diabetes (T2D) in the U.S. from 2009-2017.
Methods: The IBM® MarketScan® Commercial and Medicare databases were used to identify trends for insulin use over 9 years among people with T1D or T2D who filled a prescription for insulin in a calendar year. Total annual sample size ranged from 373,975 to 660,512. The analyses examined insulin regimen, method of delivery, and use of glucose monitoring systems separately for people with T1D or T2D. Generalized estimating equations were used to test whether trends were statistically significant.
Results: For people with either T1D or T2D, use of short/rapid insulin only and use of analog insulins increased while premix insulin use decreased (all P&lt;0.0001) from 2009 to 2017. Basal insulin only use increased for people with T2D over the study period (P&lt;0.0001). Among people with T1D, vial with pump use increased significantly; the use of disposable pens increased in both cohorts (all P&lt;0.0001). The observed use of continuous glucose monitoring (CGM) was numerically higher for patients with T1D compared to patients with T2D, although use significantly increased (both P&lt;0.0001) over the study period for both cohorts.
Conclusion: Results suggest that insulin prescribing continues to change with advances in insulin delivery technology and glucose monitoring systems.

Disclosure
M. Perez-Nieves: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. R. Juneja: Employee; Self; Eli Lilly and Company. L. Fan: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. E. Meadows: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. M.J. Lage: Consultant; Self; Eli Lilly and Company. Consultant; Spouse/Partner; Eli Lilly and Company. E.L. Eby: Employee; Self; Eli Lilly and Company.
1036-P: Bioequivalence of Ultra-Rapid Lispro (URLi) U100 and U200 Formulations in Healthy Subjects
Authors: LINNEBJERG HELLE , LABELL ELIZABETH S. , DELLVA MARY A. , LIM SHUFEN , COUTANT DAVID E. , LEOHR JENNIFER 
Published: June 2020

URLi is a novel insulin lispro formulation developed to more closely match physiological insulin secretion. URLi U200 is a concentrated formulation. This randomized, double-blind, 4-period, replicated crossover, euglycemic clamp study (NCT03616977) assessed pharmacokinetics (PK) and glucodynamics (GD) after 15 U subcutaneous doses of U100 and U200 URLi in 68 healthy subjects (mean ± SD age 39.6 ± 9.6 y).
Similar mean PK and GD profiles were observed after dosing U100 and U200 URLi. The formulations were bioequivalent (BE): the 90% CI of ratios of geometric least-square means for the maximum insulin concentration (Cmax) and total exposure (AUC0-∞) were within BE limits of 0.80-1.25. Additionally, the 90% CI for the ratios of geometric means for maximum (Gtot) and total glucose infused (Rmax) were within the BE limits.
The time to early half Cmax (early 50% tmax) occurred at approximately the same time for both formulations. Additionally, insulin exposure within the first 15 and 30 minutes was similar for U100 and U200 URLi.
The tolerability of the U200 and U100 URLi formulations were comparable. This study demonstrated that U100 and U200 URLi formulations were BE and the faster insulin absorption was maintained in the U200 formulation. The GD were similar and support the ability of patients to transfer from U100 to U200 URLi in a 1:1 unit conversion.

Disclosure
H. Linnebjerg: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. E.S. LaBell: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company, Johnson & Johnson, Novartis AG. M.A. Dellva: Employee; Self; Eli Lilly and Company. S. Lim: Employee; Self; Eli Lilly and Company. D.E. Coutant: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. J. Leohr: None.

Funding
Eli Lilly and Company
1043-P: GoBolus Study: Impact of Faster Aspart on Glycemic Control in a Real-World Population with Type 1 Diabetes on Basal-Bolus Therapy as Multiple Daily Injections Using Flash Glucose Monitoring
Authors: DANNE THOMAS , SCHWEITZER MATTHIAS AXEL , KEUTHAGE WINFRIED , KIPPER STEFAN , KRETZSCHMAR YASMIN , SIMON JÖRG , ZIEGLER RALPH 
Published: June 2020

Background and Methods: Randomized trials have shown that faster aspart (FA) improves glycemic control in patients with T1D. The German observational study GoBolus (NCT03450863) collected real-world clinical and patient-reported data of patients with T1D treated with basal/bolus therapy as multiple daily injections (MDIs), who were switched from other bolus insulins to FA by their physician.
Results: Overall, 243 patients were enrolled, with a mean age of 49.9 years, mean baseline A1C of 8.1%, mean BMI of 28.1 kg/m2 and mean diabetes duration of 18.8 years: 55.6% were male. Over 24 weeks’ FA treatment, primary endpoint (A1C) decreased by 0.19% (p&lt;0.01) without changes in insulin doses or basal/bolus insulin ratios. Flash glucose monitoring data (Figure) showed increased “time in range” (TIR, 3.9-10 mmol/L) from 46.9% to 50.1% (p=0.01) and decreased time in hyperglycemia (&gt;10 and &gt;13.9 mmol/L) from 49.1% to 46.1% (p=0.03) and 20.4% to 17.9% (p=0.01), respectively, without change for time in hypoglycemia (&lt;3.9 and &lt;3.0 mmol/L). Mean interstitial and 3-h postprandial glucose improved from 10.4 to 10.1 mmol/L (p=0.04) and 11.9 to 11.0 mmol/L (p&lt;0.01), respectively.
Conclusions: Switching bolus insulin to FA in patients with T1D on MDIs improved glycemic control, increased TIR and decreased time in hyperglycemia.

Disclosure
T. Danne: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Sanofi. M. Schweitzer: Employee; Self; Novo Nordisk A/S. W. Keuthage: Advisory Panel; Self; Deutschland GmbH, Novo Nordisk A/S, Roche Diabetes Care. Board Member; Self; Abbott, Berlin-Chemie AG. S. Kipper: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Y. Kretzschmar: Employee; Self; Novo Nordisk A/S. J. Simon: None. R. Ziegler: Advisory Panel; Self; Abbott, Lilly Diabetes, Novo Nordisk A/S, Roche Diabetes Care. Consultant; Self; Novo Nordisk A/S, Roche Diabetes Care. Speaker’s Bureau; Self; Abbott, Dexcom, Inc., Novo Nordisk A/S, Roche Diabetes Care.

Funding
Novo Nordisk
1052-P: Investigation of the Extrapancreatic Effects of the DPP-4 Inhibitor Sitagliptin: A Randomized, Double-Blinded, Placebo-Controlled Crossover Trial in Totally Pancreatectomized Patients
Authors: BAEKDAL MILLE , LUND ASGER , NIELSEN SOPHIE W. , HANSEN CARSTEN , STORKHOLM JAN H. , HARTMANN BOLETTE , HOLST JENS J. , VILSBØLL TINA , KNOP FILIP K. 
Published: June 2020

Dipeptidyl peptidase 4 (DPP-4) inhibitors increase circulating concentrations of the insulinotropic and glucagon-modulating gut hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1). The multiorgan distribution of GIP and GLP-1 receptors suggests pleiotropic extrapancreatic effects of these hormones (and thus DPP-4 inhibition), but these have been difficult to disentangle from their potent effects on the endocrine pancreas. Here, we investigated postprandial effects of the DPP-4 inhibitor sitagliptin in totally pancreatectomized (PX) patients as compared to matched healthy controls (CTRLs). In a randomized, double-blinded, placebo-controlled crossover study, 10 PX patients (age 65.7±6.4 [mean±SD] years; BMI 23.8±4.3 kg/m2) and 10 CTRLs (age 65±7.8 years; BMI 24.3±3.5 kg/m2) underwent a 3-hour liquid mixed meal test (MMT) after two doses of 150 mg sitagliptin (administered the night before and on the morning of the MMT) and placebo, respectively. Basal insulin was administered as usual; no bolus insulin was administered during study days. Blood samples were drawn throughout the experimental days. Sitagliptin did not affect fasting plasma glucose compared to placebo in CTRLs (5.4±0.2 vs. 5.5±0.1 mmol/l, P=0.6) nor in PX patients (7.7±1.0 vs. 7.9±0.9 mmol/l, P=0.88). Also, sitagliptin did not affect postprandial plasma glucose excursions as assessed by peak values, time to peak values or area under the curve in any of the groups.
In conclusion, the DPP-4 inhibitor sitagliptin has no effect on fasting plasma glucose or postprandial plasma glucose excursions in PX patients; suggesting that no or little extrapancreatic effects of GIP and GLP-1 are involved in the glucose-lowering action of DPP-4 inhibition in patients with diabetes.

Disclosure
M. Baekdal: None. A. Lund: Speaker’s Bureau; Self; AstraZeneca, Novo Nordisk A/S, Sanofi. S.W. Nielsen: None. C. Hansen: None. J.H. Storkholm: None. B. Hartmann: None. J.J. Holst: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Zealand Pharma A/S. Other Relationship; Spouse/Partner; Antag Therapeutics. T. Vilsbøll: Advisory Panel; Self; AstraZeneca, Mundipharma International, Novo Nordisk A/S, Sun Pharmaceutical Industries Ltd. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Medscape, Merck Sharp & Dohme Corp., Sanofi. F.K. Knop: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Sanofi. Consultant; Self; Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Gubra, Novo Nordisk A/S, Sanofi, Zealand Pharma A/S. Speaker’s Bureau; Self; AstraZeneca, Lupin Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Norgine B.V., Novo Nordisk A/S.