bluuebunny/crossref_metadata_2025_split huggingface dataset:
1035-P: Real-World Safety and Effectiveness of Insulin Glargine 300 U/mL (Gla-300) in People with Type 2 Diabetes (T2DM) Who Fast during Ramadan: Regional Analysis of the ORION Study
Authors: HASSANEIN MOHAMED , BUYUKBESE MEHMET A. , MALEK RACHID , PILORGET VALERIE , NAQVI MUBARAK , BERTHOU BAPTISTE , SHALTOUT INASS , SAHAY RAKESH 
Published: June 2020

ORION, a prospective observational study, evaluated the safety and effectiveness of the second-generation basal insulin analog Gla-300 in people who fast during Ramadan. Adults (≥18 years) with T2DM who intended to fast for ≥15 days during Ramadan, had taken Gla-300 for ≥8 weeks before inclusion and intended to continue during Ramadan were enrolled in 11 countries (grouped by region; Table). Mean (SD) number of fasting days was 30.1 (3.2). Mean diabetes duration ranged from 7.9 to 13.5 years and ≥77.5% had moderate/low risk associated with fasting (investigator-assessed). Proportions of people with ≥1 severe and/or symptomatic documented hypoglycemia event were low for the overall population and in Groups 1-3; 1 severe hypoglycemia event was reported in pre-Ramadan. Glycemic control improved pre- to post-Ramadan in Groups 1-3 and Gla-300 dose adjustments were minimal. In Canada, 24% of people had ≥1 severe and/or symptomatic documented hypoglycemia event in Ramadan; there was no change in glycemic control, but pre-Ramadan HbA1c target achievement was high (30.4%). In this real-world study, people with T2DM who received Gla-300 and fasted for Ramadan generally had low incidence of hypoglycemia, with no severe events in Ramadan, and slightly improved glycemic control; results from Canada varied, possibly due to longer fasting hours.

Disclosure
M. Hassanein: Advisory Panel; Self; Novo Nordisk A/S. Speaker’s Bureau; Self; Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. M.A. Buyukbese: Consultant; Self; Sanofi. R. Malek: None. V. Pilorget: Employee; Self; Sanofi. M. Naqvi: Employee; Self; Sanofi. B. Berthou: None. I. Shaltout: Advisory Panel; Self; Sanofi, Novartis, MSD, Astra Zeneca, Novo Nordisk, Lilly, Servier and Abbott. Speaker’s Bureau; Self; Sanofi, Novartis, MSD, Astra Zeneca, Novo Nordisk, Lilly, Servier and Abbott. R. Sahay: Advisory Panel; Self; Boehringer Ingelheim, Dr. Reddy’s Laboratories, Eli Lilly and Company, Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim, Eli Lilly and Company, Novo Nordisk A/S, Sanofi.

Funding
Sanofi; World Health Organization (CTRI/2019/02/017636)
1041-P: Randomized Controlled Trial on the Efficacy of Supplemental Rapid-Acting Insulin during Basal-Bolus Regimen in Non-ICU Patients with Type 2 Diabetes
Authors: VELLANKI PRIYATHAMA , CARDONA SAUMETH , URRUTIA MARIA A. , GALINDO RODOLFO J. , DAVIS GEORGIA , HAW J. SONYA , FAYFMAN MAYA , MIGDAL ALEXANDRA , GUO YI , PASQUEL FRANCISCO J. , UMPIERREZ GUILLERMO E. 
Published: June 2020

The administration of rapid-acting insulin per sliding scale (SSI) for correction of hyperglycemia in non-ICU patients with type 2 diabetes (T2D) is used with most basal-bolus insulin (BBI) regimens; however, the safety and efficacy of using SSI has not been tested in RCTs. In this non-inferiority RCT, we tested whether correction of hyperglycemia before meals and bedtime improves glycemic control in patients treated with BBI regimens.
Patients with T2D with a blood glucose (BG) &gt; 140 mg/dl treated with BBI were randomized to SSI for BG &gt;140 mg/dl (intensive supplement) or to SSI for BG &gt;260 mg/dl (non-intensive supplement). Primary outcome was difference in mean BG levels between the groups during hospital stay. There were no differences in baseline characteristics between the intensive and non-intensive supplement groups. There were no differences between groups in mean daily BG, length of stay (LOS), hypoglycemia (BG &lt; 70 or &lt; 54 mg/dl), severe hyperglycemia (BG &gt; 350 mg/dl), and total, basal, prandial or supplemental daily insulin doses (U/day). In patients with any BG 140-260 mg/dl and without BG &gt; 260 mg/dl, mean BG did not differ but non-intensive group needed more prandial insulin.
Conclusion: Adding correction/supplement SSI in non-ICU T2D patients with mild to moderate hyperglycemia (&lt;260 mg/dl) on basal bolus regimen does not improve glycemic control.

Disclosure
P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. S. Cardona: None. M.A. Urrutia: None. R.J. Galindo: Advisory Panel; Self; Lilly Diabetes. Consultant; Self; Valeritas, Inc. Research Support; Self; Novo Nordisk Inc. Other Relationship; Self; UpToDate. G. Davis: None. J. Haw: None. M. Fayfman: None. A. Migdal: None. Y. Guo: None. F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. G.E. Umpierrez: None.

Funding
National Institutes of Health
1045-P: Basal Insulins in Advanced Renal Failure: Time for a Paradigm Shift
Authors: CHAUDHURI SOUMYABRATA ROY , MAJUMDER ANIRBAN , SANYAL DEBMALYA 
Published: June 2020

Aim: To compare efficacy and safety of IDeg and IGlarU100 in T2DM patients with Stage 3 or 4 CKD.
Methods: This single-centered, retrospective, observational study evaluates efficacy and safety of insulin glargine and insulin degludec in CKD with eGFR 60 and below. T2DM patients with DKD receiving IGlarU100 or IDeg for 24 weeks and beyond were included. Data relating to anthropometry, blood pressure, renal parameters, and glycaemic control were analysed.
Results: In advanced renal failure, IDeg caused statistically significant less hypoglycemia than IGlarU100. Ironically, reverse occurred in CKD stage 3A which may be contributed by concomitant usage of SUs. Both drugs were found to be similarly efficacious in this population.
Conclusion: IDeg has lower rate of hypoglycemia in advanced renal failure T2DM patients and may be a safer option to use in this scenario.

Disclosure
S. Roy Chaudhuri: None. A. Majumder: None. D. Sanyal: None.
1046-P: Effect of Age on HbA1c, Postprandial Glucose (PPG) Control, and Hypoglycemia in Patients with T2D Treated with Ultra-Rapid Lispro (URLi) or Humalog: PRONTO-T2D
Authors: CHANG ANNETTE M. , HARDY THOMAS , ZHANG QIANYI 
Published: June 2020

URLi is a novel prandial insulin lispro formulation developed to more closely match physiological insulin secretion. PRONTO-T2D, a Phase 3, double-blind, treat-to-target study in pts with T2D, showed URLi, in a basal-bolus regimen with glargine or degludec, was non-inferior for HbA1c with superior PPG control vs. Humalog. Subgroup analyses were performed in pts &lt;65 vs. ≥65 years. Baseline characteristics were similar except age and duration of T2D (Table 1). With 26 weeks of study treatment, HbA1c improved in both treatment/age groups with endpoint mean HbA1c 6.8-6.9%. URLi significantly reduced 1- and 2-hour PPG excursions with standardized meal tests vs. Humalog in both age groups. Insulin dosing was not significantly different. Severe hypoglycemia incidence was low. While there was no treatment difference in documented hypoglycemia (glucose &lt;54 mg/dL), relative rate (URLi/Humalog) was lower in pts ≥65 vs. &lt; 65 years, with a significant treatment-by-age interaction. Nocturnal hypoglycemia was not significantly different between groups. Incidence of overall treatment-emergent adverse events was similar between treatment/age groups. URLi in a basal-bolus regimen resulted in endpoint HbA1c &lt;7% and significantly lower PPG excursions vs. Humalog in both age groups, with reduced documented hypoglycemia in older vs. younger pts.

Disclosure
A.M. Chang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. T. Hardy: Other Relationship; Self; Eli Lilly and Company. Q. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.

Funding
Eli Lilly and Company
1047-P: The Change of HOMA-IR Predicted the Remission Time in Patients with Newly Diagnosed Type 2 Diabetes after Intensive Insulin Therapy
Authors: XUESI WAN , HUANG ZHIMIN , LIU LIEHUA , LI YANBING 
Published: June 2020

Objectives: Insulin resistance is one of strong predictions on the remission in patients with newly diagnosed type 2 diabetes (T2DM) after short-term insulin intensive therapy (SIIT). Therefore, the purpose of this study is to explore if the short-term change of insulin resistance can predict the long-time remission.
Methods: This study enrolled 160 patients with newly diagnosed type 2 diabetes mellitus (103 male, aged 49.8±10.4 yrs,HbA1c11±2.1%). All of them have been treated by 2-week continuous subcutaneous insulin infusion as SIIT when new diagnosed. HOMA-IR was compared just at the termination of SIIT and later then follow up every 3 months regularly for 5 years.
Results: After short-term intensive treatment, up to 84.4%, 81.3% and 26.9% of patients achieved disease remission with T2DM at the termination of CSII, the 3rd month and 5th year follow up without use of medication. The average remission time were 27+/-615 months. The average changes of HOMA-IR in the first 3 months after SIIT were 30%+/-52%. This short-term change percent of HOMA-IR was positive related to the statue of remission at 5th-year follow-up (r = 0.778, p &lt;0.0001). The ROC curve analysis showed below.
Conclusions: Maintaining the improving insulin resistance after short-term insulin intensive therapy is essential for the long-time remission from T2DM. Lifestyle interventions might be helpful.

Disclosure
W. Xuesi: None. Z. Huang: None. L. Liu: None. Y. Li: None.

Funding
National Key Research and Development Program of China (2018YFC1314100)
105-LB: Evening Oral Insulin (ORMD-0801) Glycemic Effects in Uncontrolled T2DM Patients
Authors: ELDOR ROY , FLEMING G. ALEXANDER , NEUTEL JOEL , HOMER KENNETH E. , KIDRON MIRIAM , ROSENSTOCK JULIO 
Published: June 2020

ORMD-0801 is a novel oral human insulin formulated to increase hepatic insulin exposure, and subsequently reduce hepatic glucose production and improve glycemic control, with minimal hypoglycemia risk. In a recently completed randomized, placebo-controlled, multicenter, phase 2b, 12-week study, 354 subjects with T2DM uncontrolled by multiple oral antidiabetic drugs and with HbA1c levels ≥7.5%, received placebo or 8 mg, 16 mg or 32 mg ORMD-0801 capsules up to three times daily. Masked continuous glucose monitoring was performed during a 14-day run-in period and over the last 14 days of treatment. HbA1c levels improved from baseline for most active treatment regimens, with largest improvements recorded in the 8 mg once daily (QD) and twice daily (BID) cohorts. Glucose AUC improved from baseline following 8 mg or 32 mg QD and all tested BID treatments and was most pronounced in patients receiving 8 mg QD at bedtime. Hypoglycemia event rates were low and similar to the placebo arm. Body weight remained stable in all treatment arms and frequency of drug-related adverse events was similar across cohorts.
In summary, ORMD-0801 elicited clinically significant HbA1c reductions in poorly controlled T2DM patients on standard therapies and with mean HbA1c levels &gt;8%, without increasing hypoglycemia rate or weight. The 8 mg QD regimen appears most effective, warranting further studies to confirm the efficacy of this once daily evening dose.

Disclosure
R. Eldor: Advisory Panel; Self; Oramed. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi. Stock/Shareholder; Self; Oramed. G. Fleming: Consultant; Self; ADOCIA, Biocon, Caladrius Biosciences, Inc., Dance Biopharm Holdings, Inc., Diasome Pharmaceuticals, Inc., Intarcia Therapeutics, MannKind Corporation, NuSirt Biopharma, Inc., Oramed Pharmaceuticals, Sanofi, Tolerion, Inc. J. Neutel: None. K.E. Homer: None. M. Kidron: Employee; Self; Oramed Pharmaceuticals. Stock/Shareholder; Self; Oramed Pharmaceuticals. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc., REMD Biotherapeutics. Other Relationship; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi.
107-OR: Novel Genetic Risk Factors Influence Islet Autoimmunity Progression
Authors: ONENGUT-GUMUSCU SUNA , PAILA UMA DEVI , CHEN WEI-MIN , RATAN AAKROSH , ZHU ZHENNAN , STECK ANDREA , FROHNERT BRIGITTE I. , WAUGH KATHLEEN , WEBB-ROBERTSON BOBBIE-JO , NORRIS JILL M. , LANGE LESLIE , REWERS MARIAN , RICH STEPHEN S. 
Published: June 2020

Background: Type 1 diabetes (T1D) is determined by unknown environmental factors in genetically susceptible individuals. The design of most genome wide association studies of T1D involves comparison of cases (with varying duration of disease) with controls; hence, the genetic variants associated with T1D reflect current disease, ignoring variants that play a key role in the initiation of islet autoimmunity and the progression of subclinical disease. In this study, we focus on the genetic contribution to progression of islet autoimmunity using whole-genome sequencing in a collection of participants of the Diabetes AutoImmunity Study in the Young (DAISY).
Methods: A total of 160 persistent islet autoantibody positive DAISY subjects were sequenced, including 87 subjects who progressed to T1D and 73 “non-progressors” over a mean of 11 years since seroconversion. Following whole genome sequence alignment, single nucleotide polymorphisms (SNPs) and small insertion/deletions (indels) were identified (∼6.8 million variants), and statistical analyses performed.
Results: Genes with multiple SNPs associated with progression to T1D in subjects with islet autoimmunity (P &lt; 8.5x10-8) did not overlap with known T1D risk loci; instead, four novel regions were identified - 1q21.3 (MRPS21-PRPF3), 2p25.2 (NRIR), 3q22.1 (COL6A6), and 20p12.1 (TASP1). Functional mapping of the associated SNPs within these risk loci indicates pathways critical for response to viral infections and response to interferon signaling contribute to progression to T1D once islet autoimmunity is initiated.
Discussion: This study presents evidence that different genetic pathways may contribute to progression of islet autoimmunity from those identified once disease is established and support the need for follow-up studies to understand genetic risk factors that modulate progression of subclinical disease.

Disclosure
S. Onengut-Gumuscu: None. U. Paila: None. W. Chen: None. A. Ratan: None. Z. Zhu: None. A. Steck: None. B.I. Frohnert: None. K. Waugh: None. B. Webb-Robertson: None. J.M. Norris: None. L. Lange: None. M. Rewers: None. S.S. Rich: None.
1075-P: Long-Term Treatment with Testosterone Undecanoate Injections (TU) Improves Glycemic Control in Patients with Hypogonadism and Type 2 Diabetes (T2DM): Update of Real-World Data with 2,928 Patient-Years
Authors: SAAD FARID , HAIDER KARIM S. , HAIDER AHMAD 
Published: June 2020

Background: Prevalence of hypogonadism has been reported as high as 50% in men with T2DM. ADA Guidelines recommend assessment of hypogonadism in men with T2DM.
Methods: In a registry of 858 men with hypogonadism, 356 men (41.5%) had T2DM. 178 received TU 1000 mg/12 weeks (T-group), 178 opted against treatment (CTRL). Changes over time between groups were compared and adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups.
Results: Mean follow-up 8.2±2.9, baseline age: 61.5±5.4 (T-group) and 63.7±4.9 (CTRL) years. T-group: HbA1c progressively decreased by 3.4±0.1% at 11 years (from 9.4±1.4% to 5.8±0.3%). CTRL: HbA1c increased by 3.3±0.1% (from 7.8±0.7% to 10.5±1.4%). Estimated adjusted difference between groups: 6.7% (p&lt;0.0001 for all). Fasting glucose (mmol/L) decreased in T-group by 1.8±0.1 (from 7.8±1.2 to 5.4±0.1) and increased in CTRL by 1.7±0.1 (from 6.3±0.7 to 8.0±1.6). Difference between groups: 3.6 (p&lt;0.0001 for all). In the T-group, 87 men (48.9%) received insulin at baseline at a mean dose of 37.8±13.4 U/d. Dose requirement declined by 25.9±1.1 U/d during the observation period. In CTRL, 69 men (38.8%) received insulin at baseline at a mean dose of 31.3±6.2 U/d. Dose requirement increased by 19.3±1.1 U/d. Difference between groups: 45.2 U/d (p&lt;0.0001 for all). In men who never received insulin (91 in T-group, 89 in CTRL), HOMA-IR decreased from 9.8±2.0 to 2.3±0.6 by 7.0±0.3 (T-group) and increased from 7.1±1.3 to 12.8±1.9 by 5.4±0.3 (CTRL). Difference between groups: 12.4 (p&lt;0.0001 for all). In CTRL, 20 patients were started on insulin during the observation period.
Conclusions: Long-term testosterone therapy with TU in men with hypogonadism and T2DM progressively improved glycemic control which deteriorated in untreated men.

Disclosure
F. Saad: Consultant; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Bayer AG. K.S. Haider: None. A. Haider: None.

Funding
Bayer AG
108-LB: Hypertriglyceridemic Pancreatitis (HTGP): Response to Continuous Insulin Infusion
Authors: PULIPATI VISHNU PRIYA , AMBLEE AMBIKA , YAP SARA ELIZABETH T. , SHAKA HAFEEZ , FOGELFELD LEON 
Published: June 2020

Retrospective study of 77 HTGP patients (pt) to evaluate triglyceride (TG) response to continuous insulin infusion (CII) given in ICU using 0.1 U/kg. Median age 40 (IQR 32-45) y, 66% male, 58% Hispanic, 51% alcohol use, 74% diabetes (DM), A1c 9.5 (6-12) %, initial TG 3869 (2714-5444) mg/dl. TG goal (1000 ± 100 or less) achieved in 95% (Responder=R). The 4 pt not reaching TG goal had longer time from initial TG to CII start, 10 (2-37) vs. 3 (3-5.5) hours (h), and higher insulin needs 5.4 (1.3-6.5) vs. 1.9 (0.9-3.6) U/kg. In 73 R, time points to reach TG goal in Figure 1. R reaching TG goal in &lt; 36 (49%) vs. &gt;36 h had lower initial TG 2788 (1819-4486) vs. 4836 (3408-7053), A1C 6.7 (5.6-10.7) vs. 10.7 (8.4-12.7), BMI 28.7 (25-33) vs. 31.5 (28-37), insulin needs 0.92 (0.46-1.8) vs. 2.92 (2.0-4.7) and reached TG 50% (≤50% baseline TG) faster 13 (6-17) vs. 16 (12-32). Among R, DM (74%) vs. non-DM pt had higher initial TG 3990 (2859-6150) vs. 3512 (2142-4519), BMI 31.5 (28-36) vs. 27.7 (24-30), insulin needs 2.4 (1.3-3.8) vs. 0.82 (0.4-1.5) and took longer to reach TG 50% 16 (11-27) vs. 10 (5-15) and final TG 40 (25-57) vs. 15 (14-26). In multivariate analysis, quick TG response predictors were no DM, low initial TG, A1C. All results significant. CII was effective in reaching TG goal in 95% of pt, most within 2 days. Study suggests need for higher insulin dose in pt with late response predictors. Rate of TG 50% decline may be a real time indicator to adjust insulin rate for quicker response.

Disclosure
V. Pulipati: None. A. Amblee: None. S.T. Yap: None. H. Shaka: None. L. Fogelfeld: Research Support; Self; Bayer Healthcare Pharmaceuticals Inc., Gan & Lee Pharmaceuticals, Gilead Sciences, Inc., Merck & Co., Inc., Sanofi.
1080-P: Addressing the Safety Challenges of Aldose Reductase Inhibition: Development of AT-001 for Diabetic Cardiomyopathy, a Potent and Selective Next Generation Aldose Reductase Inhibitor
Authors: PERFETTI RICCARDO , YEPURI GAUTHAM , QUADRI NOSIRUDEEN A. , GHANNAM AMEEN F. , RAMASAMY RAVICHANDRAN , SHENDELMAN SHOSHANA 
Published: June 2020

Diabetic Cardiomyopathy (DbCM) leading to overt heart failure is a common sequelae of both type 1 and type 2 diabetes. Prior attempts to develop treatments for DbCM via inhibition of Aldose Reductase (AR) were unsuccessful, due to low AR binding affinity and off-target binding with Aldehyde Reductase (AldR), an enzyme critical for detoxification of aldehydes in the liver and normal hepatocyte function. This resulted in liver-related safety and tolerability issues with first generation ARIs. We report on the selectivity and specificity of AT-001, a novel small molecule ARI with optimized affinity and specificity for AR and minimal to zero off-target AldR activity.
Methods and Results: AT-001 was evaluated for AR binding affinity vs. zopolrestat, a prior best in class ARI, which had been challenged with liver toxicity issues in clinical development. AT-001 demonstrated logarithmically improved AR inhibitory activity (IC50 of 30 pmol for AT-001 and 10 nmol for zopolrestat). Liver enzyme evaluations demonstrated that AT-001 showed no inhibition of AldR at 50x and 100x EC50 levels in assay medium, while zopolrestat inhibited AldR by 50% and 60% respectively (spec activity of 2.3 and 1.9 mmol NADPH/min/mg prot.). Additionally no elevations of ALT/AST’s were observed with AT-001 at doses up to 50x EC50, in contrast to zopolrestat which showed dose dependent release of ALT and AST (consistent with hepatocyte damage and eventual cell death). Finally, AT-001 was evaluated in a standard off-target receptor binding analysis of 87 substrates (13 enzymes, 74 binding assays); with no significant results (&gt;50% inhibitory activity) observed.
Conclusion: The unique structure and activity of AT-001 provide potent selectivity for Aldose Reductase and lack of off-target effects. The in-vitro safety of this agent together with the positive safety data from the phase 1/2 program, supports the ongoing pivotal study in DbCM.

Disclosure
R. Perfetti: Stock/Shareholder; Self; Applied Therapeutics. G. Yepuri: None. N.A. Quadri: None. A.F. Ghannam: Employee; Self; Applied Therapeutics Inc. Stock/Shareholder; Self; Sanofi US. R. Ramasamy: Consultant; Self; Applied Therapeutics. S. Shendelman: Employee; Self; Applied Therapeutics. Stock/Shareholder; Self; Applied Therapeutics.

Funding
Applied Therapeutics (NCT04083339)
1085-P: Nasal Glucagon Was Efficacious in Reversing Insulin-Induced Hypoglycemia without Increasing Risk of Secondary Hyperglycemia
Authors: YAN YU , WANG QIANQIAN , CHILD CHRISTOPHER J. , ZHANG MICHELLE X. 
Published: June 2020

Background: Nasal glucagon (NG), a ready-to-use therapy for treatment of severe hypoglycemia, contains 3 mg glucagon dry powder absorbed passively through nasal mucosa. We evaluated efficacy, pharmacodynamics (PD), and safety of NG compared to injectable glucagon (IG) in reversing insulin-induced hypoglycemia in Caucasian and Japanese adults with T1D or T2D.
Methods: Post-hoc analyses used data from 2 randomized, cross-over studies. Treatment success was defined as an increase in BG to ≥70 mg/dL or an increase of ≥20 mg/dL from nadir BG within 15 min of receiving glucagon. PD data, including area under the curve above 140 mg/dl [∆140 AUC (1-4 hr)], were used to evaluate the risk of secondary hyperglycemia. Tolerability was assessed with treatment-emergent adverse events and a symptom questionnaire.
Results: A similar proportion of NG [97.8% (131/134)] and IG patients [97.0% (130/134)] achieved treatment success. Geometric least square mean BGmax for NG and IG were 194 and 205 mg/dL (p&lt;0.001), respectively. NG had significantly lower ∆140 AUC (1-4 hr) (p&lt;0.001). NG had similar rates of nausea and vomiting versus IG, with higher rates of side effects related to nasal administration.
Conclusions: NG was efficacious and well-tolerated in reversing insulin-induced hypoglycemia in adults with T1D or T2D and did not increase the risk of secondary hyperglycemia compared to IG.

Disclosure
Y. Yan: Employee; Self; Eli Lilly and Company. Q. Wang: Employee; Self; Eli Lilly and Company. C.J. Child: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. M.X. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.

Funding
Eli Lilly and Company