bluuebunny/crossref_metadata_2025 huggingface dataset:
2307-PUB: VN-B101: A New, Promising Drug Candidate for the Treatment of Diabetes
Authors: CHEN HUI-LING , WANG PEI-RAN
Published: June 2019

HC-N2, an active ingredient from ethanol extracts of a Chinese herbal medicine Hedychium coronarium Koenig (Zingiberaceae), has demonstrated excellent efficacy and safety profiles in diabetic animal models. Four weeks treatment with HC-N2 at 60 mg/kg significantly reduced fasting blood glucose and OGTT incremental glucose AUC by 43% (p<0.01) and 62% (p<0.001); respectively. In addition, preclinical repeat-dose toxicity study in rat and in dog both revealed NOAEL to be 972 mg/kg/day which provided a safety margin of 10 folds over the maximal recommended starting dose in phase 1 clinical study.

VN-B101, a 500 mg tablet contains 165mg active ingredient HC-N2 with 335 mg of inactive excipients, would be used in the clinical trials. The clinical study protocol of VN-B101 tablet received the IND approval from USFDA and TFDA in 2012 and 2016; respectively.

One of the major objectives of this study was to evaluate effects of VN-B101 as an adjuvant to metformin (MET) in patients with uncontrolled type 2 diabetes mellitus (T2DM). This trial was a single center, open-label, phase-I study (NCT03033433) consisting of two stages: Stage 1 was a dose-escalation study to assess the safety and tolerability profile of three escalating doses of VN-B101 (1, 2, and 4 tablets; qd; for 7 days) in healthy subjects, while Stage 2 applied VN-B101 as add-on treatment to MET in T2DM. There was no AEs or SAE found in stage 1 and stage 2 subjects. In addition, the combination treatment significantly reduced OGTT incremental glucose AUC by additional 35% (p<0.05) compared to MET monotherapy.

In summary, VN-B101 as add-on therapy to MET is safe and efficacious in T2DM inadequately controlled by MET alone. The inspiring study results encourage further clinical studies to be conducted.

Disclosure

H. Chen: None. P. Wang: None.
2308-PUB: Liraglutide 3 mg for Weight Loss in a Real-World Setting: Clinical Outcomes after 56 Weeks
Authors: BUCKLEY ADAM J. , SULIMAN MOHAMED , TIKRITI ALIA AL , LESSAN NADER , ROUX CAREL LE , TAN TRICIA M. , BARAKAT MAHA T.
Published: June 2019

Background: Liraglutide 3 mg was approved in the UAE for the treatment of obesity in residents with BMI >30 kg/m2 or BMI >27 kg/m2 with obesity-related complications and clinical use started in January 2017 at the Imperial College London Diabetes Centre (ICLDC). The proportions of participants achieving weight loss of ≥5%, ≥10% and ≥15% at 16 weeks were 60%, 23% and 6%.

Methods: Retrospective review of clinical data from a cohort of patients treated at ICLDC in Abu Dhabi and Al Ain, UAE. Inclusion criteria were treatment with Liraglutide 3 mg for weight loss and follow-up of ≥ 56 weeks (4 weeks dose escalation plus 52 weeks treatment). 93% of participants were Emirati.

Results: 322 individuals were included. Median follow-up was 485 (433-551) days and treatment was stopped in 75 individuals before end of follow-up. 91 received treatment ≥ 365 days, and 27 had no gaps in treatment > 30 days during follow-up, with a median of 265 (151-381) days of treatment. Eight participants had T2DM and 190 had IFG or IGT. 28 had prior history of bariatric surgery (18 sleeve, 8 RYGB, 2 other). Intentional to treat analysis suggested that after a year, ≥ 5% weight loss was achieved in 51%, ≥ 10% in 25% and ≥ 15% in 9%. Per protocol analysis suggested completing 1 year of treatment resulted in ≥ 5% in 83.5%, ≥ 10% in 52.7% and ≥ 15% in 22.2% of patients.

Conclusion: Weight loss continued between 16 and 56 weeks, but gaps in treatment may have impaired effectiveness.

Disclosure

A.J. Buckley: None. M. Suliman: None. A. Al Tikriti: None. N. Lessan: None. C. le Roux: Advisory Panel; Self; GI Dynamics, Inc., Herbalife International of America, Inc., Janssen Pharmaceuticals, Inc., Johnson & Johnson, Novo Nordisk A/S. Speaker's Bureau; Self; Merck Sharp & Dohme Corp. T.M. Tan: Other Relationship; Self; Novo Nordisk A/S. M.T. Barakat: None.
2309-PUB: The Effect of Linagliptin on the Microbiome of Diabetic ZDF Rats
Authors: SAYOLS SERGI , SIMON ERIC , KLEIN HOLGER , LEPARC GERMAN G. , MARK MICHAEL , LUIPPOLD GERD , KLEIN THOMAS
Published: June 2019

Recent data suggest that the individual microbiome influences the pathology of type 2 diabetes (T2D). Linagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor used for the treatment of T2D, which is excreted mainly via the bile. We investigated the microbiome of diabetic ZDF vs. normal rats and the effect of linagliptin on the gut bacterial composition over time.

Diabetic ZDF and normal rats (two groups each, of six biological replicates) were treated with linagliptin 7.2 mg/kg qd or vehicle, in 5 ml/kg Natrosol 0.5%; faeces were collected at days 0, 3 and 7. The sequencing of microbial 16S rRNA amplicons was performed at CeMeT GmbH in Tübingen, to produce between 50000 and 75000 raw reads per library, at a read length of 2x250 bp. Preprocessing, import QC and quantification of reads assigned to specific operational taxonomic units (OTUs) were carried out using the MEGAN 6 toolbox. Between 14 k and 37 k raw reads were assigned to different bacterial phyla. We then used the Phyloseq package coupled with DESeq2 to determine significant changes in the abundance of OTUs between diabetic ZDF and normal animals, and changes over time in animals treated with linagliptin vs. vehicle.

Between 20 and 27 OTUs (quantified at family level) significantly changed in untreated diabetic vs. healthy rats, in agreement with previously published studies. However, we found only weak to moderate changes in the linagliptin treated vs. untreated ZDF rats (i.e., 3 different bacterial families with significant changes in abundance after 7 days). No systematic changes in the biodiversity of the gut phyla could be attributed to linagliptin.

This study provides new knowledge on how linagliptin affects the microbiome of diabetic ZDF vs. healthy rats. Some of the changes attributable to linagliptin agree with published studies on the beneficial effect of probiotics in diabetes. However, the observed changes in the microbiota after a short treatment with linagliptin are rather weak compared with the important differences seen in diabetic vs. nondiabetic animals.

Disclosure

S. Sayols: Employee; Self; Boehringer Ingelheim International GmbH. E. Simon: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. H. Klein: Employee; Self; Boehringer Ingelheim International GmbH. G.G. Leparc: Employee; Self; Boehringer Ingelheim International GmbH. M. Mark: Employee; Self; Boehringer Ingelheim International GmbH. G. Luippold: Employee; Self; Boehringer Ingelheim International GmbH. T. Klein: Employee; Self; Boehringer Ingelheim International GmbH, Boehringer Ingelheim International GmbH.

Funding

Boehringer Ingelheim; Eli Lilly and Company
2333-PUB: CPL207-280, a Potent and Safe GPR40 Agonist for the treatment of Type 2 Diabetes
Authors: BAZYDLO-GUZENDA KATARZYNA , BUDA PAWEL , KOZLOWSKA IZABELA , MACH MATEUSZ , TESKA-KAMINSKA MALGORZATA , STELMACH FILIP , WASINSKA-KALWA MALGORZATA , GALAZKA KINGA , DUBIEL KRZYSZTOF K. , PIECZYKOLAN JERZY S. , WIECZOREK MACIEJ
Published: June 2019

Targeting GPR40 receptor has been proposed as novel modality for patients with insufficient blood sugar control or in tolerating popular drugs. It belongs to G-protein coupled receptors family and is highly expressed in pancreatic β-cells where it mediates free fatty acid-induced insulin secretion. Although several synthetic GPR40 agonists have been generated none of them found use in the clinic predominantly due to safety issues. Therefore, the greatest interest in the field has been focused on safety and favorable pharmacokinetics. In previous study we showed a new, effective GPR40 agonist, which displayed promising safety profile in vitro. Here we show the safety, biological and pharmacological effects of CPL207-280 in rats and non-human primate (NHP) T2D models.

Pharmacokinetic studies in rats and NHP showed very high bioavailability (F) (80% and 87% in rats and monkeys, respectively) of the compound CPL207-280 and favorable half-time (t1/2kel): 4,75 h in rats and 3,95 h in monkeys which can protect against compound accumulation (especially in the liver) during long term administration. CPL207-280 increased insulin secretion and showed dose-dependent improvement (at a dose range of 3-100 mg/kg) in GTT test in ZDSD rats and at a dose 15 mg/kg in diabetic NHP study. During toxicology study the maximum tolerated dose (MTD) for CPL207-280 was found at a dose of 1000 mg/kg and 500 mg/kg in rats and monkeys, respectively. In the 14-days (dose range finding) DRF study the (no observable adverse effect level) NOAEL was found at the level of 300 mg/kg and 100 mg/kg in rats and monkeys, respectively. Additionally, during a 28-days study in diabetic NHP at dose 15 mg/kg administrated p.o., no significant side effects were observed and all haematology and biochemical parameters including: total bile acids (TBA), total bilirubin (TB), ALT, AST, GGT were not changed compared to control group. This clearly demonstrates that CPL207-280 has a great potential to become a safe and effective candidate for treatment of T2D.

Disclosure

K. Bazydlo-Guzenda: Employee; Self; Celon Pharma S.A. P. Buda: Employee; Self; Celon Pharma S.A. I. Kozlowska: Employee; Self; Celon Pharma S.A. M. Mach: Employee; Self; Celon Pharma S.A. M. Teska-Kaminska: Employee; Self; Celon Pharma S.A. F. Stelmach: Employee; Self; Celon Pharma S.A. M. Wasinska-Kalwa: Employee; Self; Celon Pharma S.A. K. Galazka: Employee; Self; Celon Pharma S.A. K.K. Dubiel: Employee; Self; Celon Pharma S.A. J.S. Pieczykolan: Employee; Self; Celon Pharma S.A. M. Wieczorek: Other Relationship; Self; Celon Pharma S.A.

Funding

National Centre for Research and Development
2344-PUB: Predictors of the Glucose-Lowering or Weight-Loss Effects of Ipragliflozin and Sitagliptin
Authors: TSURUTANI YUYA , NAKAI KAZUKI , SAITO JUN , OMURA MASAO , NISHIKAWA TETSUO
Published: June 2019

Sodium-glucose cotransporter 2 inhibitor and dipeptidyl peptidase-4 inhibitor are widely used in Japan, but only a few studies have directly compared the effects of these two drugs. We have reported that ipragliflozin (Ipra) had beneficial effects on fat reduction, insulin resistance, and lipid metabolism, while sitagliptin (Sita) had beneficial effects on β-cell function in a randomized controlled study. In this subanalysis study, we screened for predictors of the glucose-lowering effects of Ipra and Sita, and the weight-loss effects of Ipra. The participants were 119 patients aged 20-75 years with type 2 diabetes, HbA1c ≥ 6.5%, and BMI ≥ 23 kg/m2, and were randomly assigned to 12 weeks of treatment with 50 mg of either Ipra or Sita. We analyzed the correlations between the change in glycated hemoglobin HbA1c (ΔHbA1c) or body weight (ΔBW) and multiple clinical variables at the baseline. In the Ipra group, the mean ΔHbA1c was -1.1% and ΔBW was -2.2 kg. There was no significant correlation between ΔHbA1c and ΔBW (ρ = 0.22, p = 0.095). ΔHbA1c had a significant positive correlation with age (ρ = 0.41, p = 0.001) and negative correlation with the HbA1c level (ρ = -0.68, p < 0.001), HOMA-IR (ρ = -0.36, p = 0.011), and ALT level (ρ = -0.34, p = 0.014), while ΔBW had a significant negative correlation with the total ketone concentration at the baseline (ρ = -0.31, p = 0.041). In the Sita group, the mean ΔHbA1c was -0.81%; no significant change in BW was seen. ΔHbA1c had a significant negative correlation with HbA1c level at the baseline (ρ = -0.42, p = 0.0016), but no significant correlation with other variables at the baseline.

In conclusion, our results suggest that the glucose-lowering effects of Ipra were more prominent in younger patients with increased insulin resistance accompanied by fatty liver, while its weight-loss effects were more prominent in patients with high total ketone concentration at the baseline. Meanwhile, the glucose-lowering effects of Sita may be exhibited regardless of the patient pathology.

Disclosure

Y. Tsurutani: Research Support; Self; Astellas Pharma Inc. K. Nakai: None. J. Saito: None. M. Omura: None. T. Nishikawa: None.
2346-PUB: Clinical Characteristics of SGLT2 Inhibitor User in Type 2 Diabetes with Atherosclerotic Cardiovascular Disease or Heart Failure in a Real-World Setting
Authors: JEONG SU JIN , PARK IE BYUNG , LEE SEUNG EUN , SHIN DONGHYUN , KIM KYOUNG-AH
Published: June 2019

The treatment approach to type 2 diabetes (T2D) should begin with an assessment of atherosclerotic cardiovascular disease (ASCVD). Sodium-glucose cotransporter-2 inhibitors (SGLT2i) should be considered in T2D with established ASCVD or heart failure (HF). In this study, we analyzed the prescription patterns of ant-diabetic treatment in T2D with ASCVD or HF in real-world clinical practice. During 1-year period (2018), we reviewed 1553 consecutive T2D patients with ASCVD or HF visiting an endocrinology outpatient clinic from four teaching hospitals in Seoul Capital Area after excluding patients aged ≥85 years or estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73m2. Mean age was 65 years, duration of diabetes 11 years, and duration of ASCVD 7 years; HbA1C 7.5%, eGFR 80 ml/min/1.73m2, and body mass index (BMI) 25.6 kg/m2. ASCVD characteristics were stroke 27%, coronary artery disease (CAD) 59%, stroke+CAD 5%, peripheral arterial occlusive disease 1%, and heart failure 8%. Over four years, the initiation of SGLT2i has increased (2015=9% vs. 2018=42%). Compared with SGLT2i non-users (80%, n=1249), SGLT2i users (20%, n=304) tended to be younger (60 vs. 67) and with significantly lower stroke (16% vs. 30%). They also had higher BMI (27 vs. 25), worse HbA1C levels (8.1 vs. 7.4), and higher eGFR (88 vs. 78). Non-users with HbA1C 8 ∼9% (n=245) who might be eligible for switching to SGLT2i showed a longer duration of diabetes (14 vs. 11 years) or ASCVD (7.4 vs. 6.5 years) compared to users. The most common prescription pattern in non-users was triple oral glucose-lowering drugs (OGLD) followed by dual OGLD while in users, dual OGLD followed by triple OGLD. Interestingly, 0.5% were on GLP-1RA in this study. In contrast to clinical guidelines, a small proportion of T2D with ASCVD or HF is currently treated with SGLT2i in real-world clinical practice. The limiting factors for failing to initiate SGLT2i are age, stoke, eGFR, and clinical inertia.

Disclosure

S. Jeong: None. I. Park: None. S. Lee: None. D. Shin: None. K. Kim: None.
2349-PUB: Long-Term Efficacy and Safety of Canagliflozin in Type 2 Diabetes: A 52-Week Indian Experience
Authors: MAHAPATRA HARIBALLAV , KHUNTIA MONALISA , MAHAPATRA LAXMINARAYAN , DAS SREEYA , JENA BISWARANJAN , MISHRA SUSANT , PADHI RAJESH K. , JENA APURBA RANJAN , KHATUA RANJIT KUMAR , PATWARI AJAY , PRADHAN SANTOSH KUMAR , BISWAL SOUBHAGYA , NAYAK SAURABHA , MISHRA UMA SHANKAR , SAHOO ABHAY KUMAR
Published: June 2019

Introduction: SGLT2 inhibitors are a new class of drugs approved for type 2 diabetes (T2DM) and have been placed high in treatment algorithm following the robust data supporting their use.

Aim: We studied the long term efficacy and safety of Canagliglozin (CANA) versus placebo in Indian adults with type 2 diabetes who were inadequately controlled with metformin (MET) monotherapy.

Methods: The study was undertaken at Sevayan Diabetes Centre, India with due consent from participants. Patients (HbA1c 8-12%) on MET were invited to participate. Those on other antidiabetic drugs or insulin were excluded. The CANA arm was administered CANA 100mg OD in addition to MET. The other group received placebo (PBO) and MET. Doses of MET were kept unchanged throughout the study. Antihypertensive, statin and antiplatelets were continued unchanged. Participants were compared after 52 weeks of enrollment.

Result: Data of 96 (M/F 62/34) subjects were available for analysis (n=46 on CANA, n=50 on PBO). Groups were similar at baseline. Pre-enrollment HbA1c (%), FPG (mg%) and PPG (mg%) in CANA and PBO arm were 9.94±1.04 and 9.89±1.1, 193.2±26.1 and 193.6±33.0 and 261.3±28.1 and 260.5±30.3 in order (p=NS for all). After 52 weeks of treatment, CANA arm showed clinically meaningful 1.61±1.05% reduction in HbA1c from baseline (p= 0.0048), whereas the PBO arm witnessed a non-significant elevation in HbA1c. Use of CANA significantly decreased FPG by 60.05±17.75mg% and PPG by 62.35±21.92 mg%, whereas the PBO group noticed no appreciable changes in those glycemic parameters. Mycotic infections were common in CANA users (n=6 vs. n=3 in PBO), but improved with personal hygiene. Incidences of documented hypoglycemia were similar in both groups (12 in each).

Conclusion: In Indian diabetics uncontrolled with metformin monotherapy, addition of canagliflozin resulted in statistically significant and durable reductions in HbA1c, FPG and PPG over 52 weeks period. Participants tolerated CANA well without any additional risk of hypoglycemia.

Disclosure

H. Mahapatra: None. M. Khuntia: None. L. Mahapatra: None. S. Das: None. B. Jena: None. S. Mishra: None. R.K. Padhi: None. A.R. Jena: None. R.K. Khatua: None. A. Patwari: None. S.K. Pradhan: None. S. Biswal: None. S. Nayak: None. U.S. Mishra: None. A.K. Sahoo: None.

Funding

Jyoti Foundation
2351-PUB: Influence of Short-Term Improvements in Glycemic Control with Intensive Insulin Therapy on Pancreatic a-Cell Function and the Relationship between Concurrent SGLT2 Inhibitor Therapy and Insulin Withdrawal
Authors: MATSUI MAKIKO , TAKAHASHI HIROSHI , SAWANO SHOUKO , MORI YUTAKA , UTSUNOMIYA KAZUNORI
Published: June 2019

Objective: We investigated the relationship between insulin withdrawal (IW), endogenous insulin recovery, and concurrent SGLT2 inhibitor (SGLT2i) therapy.

Patients and Methods: Of the 78 type 2 diabetic patients admitted for glycemic control and subjected to meal tolerance tests (MTT) on the next day after admission and immediately before discharge using the same diabetes diet while off treatment, 39 patients who had received intensive insulin therapy after admission were subjected to retrospective analysis. Of these, 26 patients in whom insulin withdrawal had been achieved during admission were divided into those who had received concurrent SGLT2i therapy (n=19) and those who had not (n=7). Insulin secretion in terms of ΔCPR/ΔPG 0-30 min and AUC-CPR 0-2 h during the MTT was compared at admission and discharge.

Results: 1) While there was no significant difference between those with IW and those without IW in their age, BMI, HbA1c, C-peptide index and urinary CPR excretion at admission, significantly more patients with IW had received SGLT2i than those without IW (P < 0.001). Again, ΔCPR/ΔPG 0-30 min and AUC-CPR 0-2 h were significantly (p<0.001) increased in those with IW but not in those without IW. 2) In those with IW, while ΔCPR/ΔPG 0-30 min and AUC-CPR 0-2 h were significantly (p<0.05) increased in both of those with SGLT2i and those without, the time to IW was shown to be significantly shorter (p<0.01), the maximum daily insulin dose lower, and the duration of hospital stay shorter, in those with SGLT2i therapy than in those without.

Conclusions: Study results confirmed that endogenous insulin secretion was significantly restored in those with IW and that the time to IW was significantly shorter in those with concurrent SGLT2i therapy than in those without, suggesting a role for SGLT2i in achieving IW.

Disclosure

M. Matsui: None. H. Takahashi: None. S. Sawano: None. Y. Mori: None. K. Utsunomiya: None.
2354-PUB: Estimating Improvement of TGF Mechanism from Changes of Urinary Glucose and Sodium Excretion by SGLT2 Inhibitors
Authors: WATANABE CHIZURU , MORI YASUMICHI
Published: June 2019

The renoprotective effect through the tubuloglomerular feedback mechanism (TGF) with the Sodium-glucose cotransporter2 inhibitor (SG) attracts attention. We investigated whether the improvement of TGF can be estimated from urinary glucose (UG) and urinary sodium (UNa) excretion, and from other parameters by assessing the changes of urinary findings in patients using SG (Dapagliflozin, Canagliflozin, Empagliflozin). Type 2 diabetes patients with SG who UG and UNa excretion were measured regularly were enrolled in this study. To correct for a postprandial increase of UG due to elevated plasma glucose(PG) levels, the creatinine-corrected UG (cUG: mg/mgCr) was calculated as follows. (The average PG level (AG mg/dl) = 28.7 × HbA1c- 46.7 (Diabetes Care 2008 Aug; 31(8): 1473-1478), the estimated UG (eUG) = UG × AG/PG). Then cUG was corrected for urinary creatinine excretion.) We analyzed these data at before, after 1, 3, 6, and 12 months (M) of SG treatment. Eighteen patients (14 men and 4 women, aged 54.9 ± 6.9 years, eGFR > 100 in 3 and < 60 in 2 patients) were investigated these parameters. Uric acid (UA), urine pH(pH) decreased after treatment, eGFR remained below baseline throughout the study period (p< 0.05). About the mean (SE) UNa/cUG ratio, no differences were observed in this study(1M 2.9 (0.5)/3M2.6 (0.5)/6M2.3 (0.5)/12M 2.6 (0.4)). The UNa/cUG ratio was negatively correlated with HbA1c and eGFR. eGFR decreased more markedly in the patients with a baseline eGFR>100. eGFR was negatively correlated with the UNa/cUG ratio and UA(p<0.05). The renoprotective effect according to TGF improvement might be obtained in the patients whom cUG excretion increased remarkably, furthermore UA decreased and pH was lower. If the UNa/cUG ratio exceeds 2.6, the intraglomerular pressure cannot be improved sufficiently because salt intake is higher and UNa excretion increases independently of UG excretion. The UNa/UG ratio can be used to estimate improvement of TGF by SG in clinical practice.

Disclosure

C. Watanabe: None. Y. Mori: None.
2358-PUB: Efficacy and Safety of Tofogliflozin on 24-hr Glucose Profile Based on Continuous Glucose Monitoring—Crossover Study of Sodium-Glucose Cotransporter 2 Inhibitor
Authors: KUROZUMI AKIRA , OKADA YOSUKE , GOSHIMA YUKIKO , OTSUKA TAKASHI , NARISAWA MANABU , TORIMOTO KEIICHI , TANAKA YOSHIYA
Published: June 2019

Background: Tofogliflozin (TOFO) has the highest selectivity to sodium-glucose co-transporter 2 (SGLT2) relative to SGLT1 (2900 times) and does not promote urinary glucose excretion at hypoglycemia compared with phlorhizin and does not enhance further lowering of glucose. To compare the impact of TOFO and ipragliflozin (IPR) on hypoglycemia in patients with T2DM, treated with sulfonylureas.

Methods: 30 patients were allocated to either 20 mg TOFO or 50 mg IPR and wore a continuous glucose monitoring (CGM, ipro2®) for 5 days at 3 times in a cross-over manner. The primary outcome measure was proportion of time over 24 hours with glucose less than 70 mg/dl detected by CGM and this was compared between two SGLT2 inhibitors.

Results: The percent time spent at glucose less than 70 mg/dl was 0.48, 2.77 and 0.06%, before treatment with SGLT2 inhibitors and treatment with IPR and TOFO (p=0.1135, between SGLT2 inhibitors). The addition of either IPR or TOFO to sulfonylureas markedly and significantly improved other CGM-derived parameters including average glucose, standard deviation of glucose, mean postprandial glucose excursion, percent time with glucose >140, >180 and >200 mg/dl, area over the curve <70, area under the curve >140, >180 and >200, maximum glucose. However, there were no significant differences in these parameters between the SGLT2 inhibitors. We also conducted a sub-analysis in 16 patients who received DPP-4 inhibitors. The results showed the percent time at glucose level <70 mg/dl (p=0.1118, between SGLT2 inhibitors) and the area over the curve <70 (p=0.0631, between SGLT2 inhibitors), tended to be lower in patients treated with TOFO.

Conclusion: Based on the CGM the addition of TOFO to sulfonylureas tended to decrease the percent time spent in hypoglycemia in T2DM. The addition of SGLT2 inhibitors to sulfonylureas improved the average glucose level and reduced glucose fluctuations without increasing hypoglycemia.

Disclosure

A. Kurozumi: None. Y. Okada: None. Y. Goshima: None. T. Otsuka: None. M. Narisawa: None. K. Torimoto: None. Y. Tanaka: None.
2359-PUB: Clinical Effectiveness of Canagliflozin 100mg in T2DM Patients—A Real-World Study
Authors: CHAKRAVORTY SAIBAL , PATEL VIKAS KUMAR
Published: June 2019

Objectives: To evaluate the clinical effectiveness of canagliflozin 100 mg (cana 100) in type 2 diabetes mellitus (T2DM) patients in an actual practice setting and to determine the effect of Canagliflozin on determinants of adiposity like body weight and body mass index (BMI).

Methods: In this retrospective cohort study, we used the private clinic medical records database. We included individuals with T2DM who were initiated Canagliflozin 100 mg at any time before 24 weeks (± 2 weeks). Changes in HbA1c, fasting plasma glucose (FPG), post-prandial glucose (PPG), body weight, BMI, occurrence of adverse effects/events at 12 and 24 weeks from baseline were evaluated.

Results: We identified 50 individuals with T2DM who were initiated with Cana 100 mg 24weeks (± 2 weeks) prior to collection of data. Individuals were, on average 53.3 ± 6.23 years old and 28% were female. Mean HbA1c, FPG, PPG, SBP, DBP, weight, BMI at baseline were 8.4%, 158.7 mg/dl, 236.5 mg/dl, 124.9 mm Hg, 82.3 mm Hg, 71.1 kg and 27.2 kg/m2 respectively. At 12 weeks, mean HbA1c decreased by 0.9%, PPG reduced by 53.6 mg/dl, weight decreased by 1.4 kg, BMI reduced by 0.5 kg/m2. At 24 weeks, outcomes were improved further: 1.6% reduction in HbA1c, 30.4 mg/dl reduction in FPG, 76.1 mg/dl reduction in PPG, 2.1 kg reduction in weight, 0.8 kg/m2 reduction in BMI. 6 patients reported incidence of genital infections and was treated symptomatically.

Discussion: In clinical trials, Canagliflozin 100 mg has shown efficacy in reducing HbA1c, FPG, PPG, SBP, DBP and body weight. The present study demonstrated efficacy of Cana 100 mg in T2DM patients under real world setting with similar reductions in HbA1c and body weight but slightly higher reductions in FPG and PPG than those shown in clinical trials. The study also showed reductions in determinants of adiposity like body weight and BMI.

Conclusion: The real-world data suggests that Cana 100 mg improved parameters of glycemic control, adiposity and body weight in T2DM patients in line with clinical trial outcomes.

Disclosure

S. Chakravorty: None.
2363-PUB: The Efficacy of Low vs. High FDA-Approved SGLT2 Inhibitor Dose Compared with DPP-4 Inhibitors: A Meta-analysis
Authors: UHRIG JARROD , MISHRIKY BASEM M. , PAGE STEPHANIE O. , SEWELL KERRY , POWELL JAMES R. , PATIL SHIVAJIRAO P. , CUMMINGS DOYLE M.
Published: June 2019

All FDA-approved SGLT2 inhibitors (SGLT2i) are currently available in two doses. While most SGLT2i have demonstrated CV benefit, there may be a difference in hemoglobin A1c (A1c) reduction between both doses. We performed a meta-analysis to evaluate the efficacy of both SGLT2i doses compared to maximum DPP-4 inhibitor (DPP-4i) dose.

We searched MEDLINE, EMBASE, CENTRAL, and CINAHL for randomized trials comparing at least one FDA-approved SGLT2i dose to maximum DPP-4i dose in type 2 diabetes and reporting a change in A1c. We performed two separate analyses according to dose (low SGLT2i dose vs. DPP-4i and high SGLT2i dose vs. DPP-4i).

We included 12 trials. There was a significantly greater A1c reduction favoring lower SGLT2i dose compared to DPP-4i at ≥52 weeks (w) but not at ≤26 w (MD [95% CI] = -0.12% [-0.23, -0.02] and 0.00% [-0.06, 0.07] respectively) with an absolute A1c reduction of -0.76% vs. -0.75% at ≤26 w and -0.71% vs. -0.58% at ≥52 w respectively. When comparing higher SGLT2i dose vs. DPP-4i, there was a significantly greater A1c reduction for SGLT2i at ≤26 and ≥52 w (MD [95% CI] = -0.13% [-0.20, -0.05] and -0.26% [-0.36, -0.16] respectively) with an absolute A1c reduction of -0.91% vs. -0.77% at ≤26 w and -0.83% vs. -0.55% at ≥52 w respectively.

We conclude that low SGLT2i dose had similar A1c reduction as DPP-4i in early treatment but became significant as treatment was prolonged. Higher SGLT2i dose is favored over DPP-4i.

Disclosure

J. Uhrig: None. B.M. Mishriky: None. S.O. Page: None. K. Sewell: None. J.R. Powell: None. S.P. Patil: Research Support; Self; Novo Nordisk Inc. D.M. Cummings: None.
2369-PUB: The Type 1 Diabetes Care Index: A Novel Metric to Assess Overall Performance of a Pediatric Diabetes Program
Authors: OBRYNBA KATHRYN , INDYK JUSTIN A. , GANDHI KAJAL , BUCKINGHAM DON A. , KRAMER ALYSSA M. , HONG K. MING , GLICK BETHANY , WELLS TRAVIS , BARNARD-KIRK TOYETTA C. , SMITH MICHAEL-JOHN L. , MOFFETT AMY M. , KAMBOJ MANMOHAN K.
Published: June 2019

Objective: Performance in providing optimal type 1 diabetes care has historically focused on only one metric, HbA1c. Our objectives were to design and test a metric that evaluated overall quality of care and to use this metric to drive improvement within our diabetes program.

Methods: The Type 1 Diabetes Care Index (T1DCI) aggregates missed opportunities for best practices into a composite score that reflects overall program performance. Elements of optimal care that should be reliably delivered were compiled into 14 domains over three areas: (1) Delivery of patient care, (2) Preventative Screening, (3) Psychosocial support. The T1DCI is the aggregate number of missed opportunities to provide quality care over a given time period. A lower T1DCI reflects better care and overall improved system performance.

Results: The T1DCI was easy to calculate and implement, and was well accepted by our diabetes team. The annual T1DCI progressively decreased from 5,338 at baseline to 3,821 after 10 months of utilization, a 14% reduction. Improvements in care were realized across some index domains and areas for focusing improvement efforts were recognized in others. New initiatives to provide optimal care were created.

Conclusions: The T1DCI is a useful metric to evaluate the ability of our program to deliver optimal care, and to document performance improvement across a broad range of domains.

Disclosure

K. Obrynba: Consultant; Self; Dexcom, Inc. J.A. Indyk: None. K. Gandhi: None. D.A. Buckingham: None. A.M. Kramer: None. K. Hong: None. B. Glick: None. T. Wells: None. T.C. Barnard-Kirk: None. M.L. Smith: None. A.M. Moffett: None. M.K. Kamboj: None.
237-LB: Identification of Small Molecules That Increase Beta-Cell Mass in Hyperinsulinemic Zebrafish Alström Syndrome Model
Authors: DUNLEAVEY JESSICA , ANNIS DAVID A. , HOSTELLEY TIMOTHY L. , ZAGHLOUL NORANN A.
Published: June 2019

Alström syndrome is an autosomal recessive obesity ciliopathy caused by loss-of-function mutations in the ALMS1 gene. In addition to multi-organ dysfunction, such as cardiomyopathy, retinal degeneration, and renal dysfunction, the disorder is characterized by high rates of obesity, insulin resistance and early onset type 2 diabetes mellitus (T2DM). We previously published data supporting the alms1 loss-of-function zebrafish mutant as a monogenic model for mechanistic interrogation of T2DM phenotypes. Both adult and larval alms1-/- animals exhibit reduced insulin+ areas alongside defective peripheral glucose uptake and concomitant hyperinsulinemia in larval alms1-/- animals. Gene expression changes in beta-cells isolated from alms1-/- mutants revealed changes consistent with insulin hyperproduction, insulin hypersecretion and glucose sensing failure. Therefore, we used this model, in which hyperinsulinemia is the primary and causative defect underlying generation of T2DM, in a high-throughput screen to examine small molecule compounds effecting pancreatic mass in vivo. The external development, simple growing conditions, and large number of progeny in the zebrafish allow for rapid screening with parallel elimination of lethal compounds. We examined the Microsource Spectrum Collection 2000, a library of 2,560 compounds, for those which increase beta-cell mass in wildtype, alms1-/- animals or both. These identified compounds are indicated in future studies for beta-cell proliferation pathways, T2DM diabetes-specific interactions, and potential targets for future therapeutic development.

Disclosure

J. Dunleavey: None. D.A. Annis: None. T.L. Hostelley: None. N.A. Zaghloul: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases
2379-PUB: Team-Based Diabetes Care Demonstrates Sustained Effect on A1C
Authors: VIOLAGO JANELLE , BONONI PATRICIA
Published: June 2019

Background: One of the goals of DM management is to achieve glycemic control to prevent or delay acute and chronic complications. ADA recommends planned visits through team-based approach to improve delivery of DM care. AHN Diabetes Academy (DA) is a 12-week team-based care program for patients w/A1C >9%, T1DM, or worsening complications.

Objective: Determine if patients who participated in DA have sustained glucose control at 1 year.

Method: Compare A1C at the start, end of DA and at 1-year follow-up.

Results: A total of 221 patients were enrolled from 9/26/16 to 10/22/17. Seventy-seven % had T2DM, 21% had T1, 2% had T1.5. Thirty-nine were lost to follow-up or did not have A1C at 1 year, allowing data analysis for 182 patients at 1 year. Mean A1C decreased significantly from 9.4 to 7.7% for all patients from enrollment to discharge; A1C at 1-year follow-up was 7.8%, unchanged from discharge showing sustained glycemic control at 1 year (Figure). When DM subtypes were analyzed, mean A1C decreased significantly for T1 and T2 from enrollment to discharge, no statistical change in T1.5 (likely due to small sample size). No significant change in mean A1C from discharge to 1 year for all subtypes.

Conclusion: AHN DA achieved sustained glycemic control at 1 year after completion of 12-week team-based program. Teaching Points: Team based care attains sustained glycemic control at 1 year, is effective for T1 and T2DM, and benefits those at high risk for acute and chronic complications.

Disclosure

J. Violago: Stock/Shareholder; Spouse/Partner; Abbott, AbbVie Inc., Cardinal Health, Eli Lilly and Company, Johnson & Johnson, Merck & Co., Inc., Pfizer Inc. P. Bononi: Other Relationship; Self; Medtronic.
2393-PUB: First Metabolic Control Results in Insulin-Treated Diabetes Patients from Republic of Macedonia Derived from National eHealth System
Authors: SMOKOVSKI IVICA , MILENKOVIC TATJANA
Published: June 2019

Republic of Macedonia (RoM) is estimated to have third highest diabetes prevalence in Europe. National eHealth System (NeHS) was introduced since 2015, enabling physicians to optionally record metabolic parameters. Our aim was to evaluate national metabolic control in insulin-treated pts, based on data derived from NeHS. NeHS was searched for all insulin-treated pts, as of 01-May-2017, with data in their Electronic Healthcare Records (EHR) for any of following parameters: HbA1c, BMI, Total Cholesterol (TC), LDL Cholesterol (LDL), Triglycerides (TG), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP). Mean values were calculated and number of pts identified to pre-specified thresholds: HbA1c - 7% and 8%; BMI - 25 kg/m2 and 30 kg/m2; TC - 5 mmol/l; LDL - 2.6 mmol/l; TG - 1.7 mmol/l; SBP - 140 mmHg and DBP - 90 mmHg. Total number of insulin-treated pts in RoM was 37,011 out of 84,568 diagnosed pts (43.8%). Of those, 6.204 (16.8%), mean age 63.8 ± 11.7 years, 54.7% women, were identified as having data in EHR for any metabolic parameter. Mean HbA1c was 7.8 ± 1.8% (n=6,204); 2,346 pts (37.8%) ≤ 7%, 1,607 (25.9%) >7% and ≤ 8%; and 2,251 (36.3%) >8%. Mean BMI was 30.4 ± 5.2 kg/m2 (n=1,920); 273 pts (14.2%) ≤ 25 kg/m2, 739 (38.5%) >25 and ≤ 30 kg/m2, and 908 (47.3%) >30 kg/m2. Mean TC was 5.3 ± 1.4 mmol/l (n=1,838); 988 pts (53.8%) >5 mmol/l. Mean LDL was 3.2 ± 1.1 mmol/l (n=433); 290 pts (67.0%) >2.6 mmol/l. Mean TG was 2.3 ± 1.6 mmol/l (n=1,588); 938 pts (59.1%) >1.7 mmol/l. Mean SBP was 134.5 ± 17.3 mmHg (n=1,055); 232 pts (22.0%) >140 mmHg. Mean DBP was 81.1 ± 8.5 mmHg (n=1,055); 65 pts (6.2%) >90 mmHg. These are the first metabolic control results in insulin-treated pts from RoM, derived from NeHS. There is a need for improvement of glycemic control (36.3% of pts with HbA1c >8%), weight and lipid management. Since 16.8% of pts have any metabolic data in EHR, change from optional to mandatory recording is necessary to improve individual and national metabolic control.

Disclosure

I. Smokovski: Advisory Panel; Self; Sanofi. T. Milenkovic: None.
2408-PUB: Benchmarking Care Outcomes for Youth with Diabetes after Transition to Adult Care in Australia
Authors: HOLMES-WALKER JANE , RUETER PHIDIAS , FARRELL KAYE
Published: June 2019

In 2001 a model of care for transition of youth with diabetes (YWD) was implemented at Westmead Hospital and published in 2007. In 2017, Australian National Diabetes audit (ANDA) conducted a month survey of all people with diabetes attending participating centers. The Australian Diabetes Data Network (ADDN) is a newly established national database.

Aim: To determine if benefits are conferred by a youth specific transition care model as compared with other Australian adult health care settings for YWD age 16-25.

Methods: An audit of all T1D Westmead clinic attendees aged 16-25 in 2017 including age, duration diabetes, HbA1c, urine microalbumin/creatinine ratio in the last 12 months, BP, most recent retinal review and results compared with the ANDA outcomes for youth attending adult health care settings for management of diabetes. Subjects within 1 year diagnosis and pregnancy excluded.

Results: Key: HbA1c median (25th-75th centile), [n] missing * p<0.05. HbA1c did not differ across all adult centers. In subgroup analysis only MDI treated were lower in the ANDA centers. A significantly greater proportion had urine microalbumin screening and BP screening, in the Westmead cohort.

Conclusion: Similar levels of diabetes control were achieved regardless of center indicating importance of follow-up in this age group although control was suboptimal. Complications screening was more effective with a dedicated transition.

Disclosure

J. Holmes-Walker: None. P. Rueter: None. K. Farrell: None.
2409-PUB: Assessment of Oral Microbiota in Adolescents with Type 1 Diabetes Mellitus and Periodontal Disease
Authors: CHAKRABORTY PAMPITA , GHOSH SUJOY
Published: June 2019

Background and Aims: Periodontal disease (PD) is a complex chronic inflammatory disease in which inflammation in the periodontal tissues is stimulated by the long-term presence of the subgingival biofilm. Various studies have investigated the role of inflammatory mechanisms in the link between PD and diabetes (DM), relatively few have investigated relationships between the oral microbiota and DM. Thus, qualitative and quantitative analyses of biofilms in diabetic cases are important to find the exact association between them. Here our aim was to elucidate the role of the microbiome in PD and its association with type 1 diabetes (T1D).

Methods: Age matched individuals was selected. The cohort for plaque was stratified into 3 groups- those having T1D (n = 9), periodontal disease (PD) (n = 8) and both T1D and PD (DP) (n=11).

Results: Detailed analysis of the taxonomic differences revealed seven statistically significant genera and one phylum. The phylum of Firmicutes was significantly over expressed in PD group (p = 0.009). The genera of Abiotrophia, Actinomyces, Peptostreptococcusand Streptococcuswere over abundant in the PD group (p < 0.05). Similarly, Aggregatibacter was significantly over abundant in only T1D and Campylobacter in only DP. Comparison between T1D and PD also revealed Proteobacteriato be significantly abundant in T1D (p = 0.042) but not in PD samples. Also, culture-based biofilm study showed significant growth in periodontal cases with poorly controlled glycemia as compared to the T1D with good glycemic control and healthy controls. Biofilm forming bacteria was commonly isolated and identified from the oral sample by the standard bacteria culture and metagenome sequencing.

Conclusion: Our study enriches the understanding of oral microbiota and sheds light on the identification of certain microorganism and glycaemic control in the pathogenesis of PD in T1D, which may have implication in treatment and management of PD in T1D.

Disclosure

P. Chakraborty: None. S. Ghosh: None.

Funding

Department of Science & Technology, Government of India, West Bengal; Research Society for the Study of Diabetes in India
2418-PUB: Incident Diabetes Complications among Women with T1D Based on Parity
Authors: POLSKY SARIT , FOSTER NICOLE C. , DUBOSE STEPHANIE , AGARWAL SHIVANI , LYONS SARAH , PETERS ANNE L. , UWAIFO GABRIEL I. , DIMEGLIO LINDA , SHERR JENNIFER , LEVY CAROL J.
Published: June 2019

We aimed to assess the association between pregnancy and occurrence of diabetes-related complications in women with type 1 diabetes (T1D). Females 16-40 years old in the T1D Exchange clinic registry completing an initial questionnaire during 2011-13 and repeating it between 2016-18 (N=497; age 22±5 years, duration 12 [6,17] years, 87% non-Hispanic White) were categorized into 2 cohorts: first pregnancy during 2011-13 (preg; n=28) and never pregnant (never; n=469). No participants had complications reported at baseline. Funduscopic exam data were not uniformly available. There was a trend for lower HbA1c 5 years after study enrollment in the preg group (7.3%±1.3%) compared with the never group (7.9%±1.4%), P=0.14 adjusted for age, race/ethnicity, and body mass index. Both albuminuria and nephropathy within 5 years of study enrollment were found at higher frequency in the women who had never been pregnant (Table). Rates of neuropathy within 5 years of enrollment were similar between the groups. While rates of cardiovascular disease within 5 years of study enrollment were low for both groups (0 in preg group and 2 participants in never group), the pregnant cohort despite having lower A1c had higher frequency of some cardiovascular disease risk factors (e.g., obesity). In persons with T1D without reported complications at enrollment, pregnancy was not associated with new complication development 5 years after delivery.

Disclosure

S. Polsky: Consultant; Self; Jaeb Center for Health Research. Research Support; Self; Barbara Davis Center for Diabetes, Children's Diabetes Foundation, Dexcom, Inc., Eli Lilly and Company, JDRF, Leona & Harry Helmsley Charitable Trust, National Institute of Diabetes and Digestive and Kidney Diseases, Sanofi US. N.C. Foster: None. S. DuBose: None. S. Agarwal: None. S. Lyons: None. A.L. Peters: Advisory Panel; Self; Abbott, Becton, Dickinson and Company, Bigfoot Biomedical, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Livongo Health, MannKind Corporation, Medscape, Merck & Co., Inc., Omada Health, Inc., OptumRx, Inc., Sanofi US, Zafgen, Inc. Research Support; Self; AstraZeneca, Dexcom, Inc., Jaeb Center for Health Research, MannKind Corporation, National Institute of Diabetes and Digestive and Kidney Diseases. Speaker's Bureau; Self; Novo Nordisk Inc. G.I. Uwaifo: None. L. DiMeglio: Research Support; Self; Amgen Inc., Caladrius Biosciences, Inc., Janssen Research & Development, Medtronic, Sanofi. Other Relationship; Self; Dexcom, Inc. J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Eli Lilly and Company, Insulet Corporation. Consultant; Self; Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi. Research Support; Self; Dexcom, Inc., Insulet Corporation. C.J. Levy: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Allergan.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust
2427-PUB: Role of Cardiac Autonomic Alterations and of Free Fatty Acids (FFA) on Hypertension in Overweight Patients
Authors: REZKI AMEL , FYSEKIDIS MARINOS , COSSON EMMANUEL , VALENSI PAUL
Published: June 2019

Objective: In diabetic patients, autonomic alterations are associated with hypertension. In healthy individuals, FFAs were shown to enhance sympathetic activity. We aimed to examine the influence of autonomic function alterations and FFA on hypertension and artery stiffness (pulse wave velocity, PWV) in overweight patients with normal or impaired glucose intolerance (NGT orIGT) or orally-treated type 2 diabetes.

Patients and Methods: We included 122 normotensive or well-controlled hypertensive patients;38 NGTs, 28 IGTs, 15 well-controlled T2Ds, 41 poorly-controlled T2Ds; meanage 41.1/41.7/53.8/54.2 years BMI 38.4/36.6/28.7/29.3 kg/m²; HbA1c 5.2/5.5/6.7/9.1% respectively. At fasting, cardiac vagal (HFnu-HR) and sympathetic (LFnu-HR) activity and sympatho-vagal balance (LF/HF-HR) were measured by spectral analysis of heart rate variations, PWV by applanation tonometry;FFA measured in IGTs and poorly-controlled T2Ds.

Results: Spectral indexes were similar in NGT, IGT and well-controlled T2D patients (meanHF-HRnu 68% andLF-HRnu 32%), but different vs. poorly-controlled T2Ds (37% and63%, respectively). Comparedto patients with HF-HR>median value, those with HF-HR<median were older (p<0.01), had lower BMI (p<0.05); similar glycemic status, HbA1c, PWV; higher LF/HF-HR(p<0.001) and more of them were hypertensive (40% vs. 20%, p<0.04), these differences remaining significant after adjustment for age, BMI, glycemic status. FFA correlated positively with LF-HR and negatively with HF-HR (p<0.04), also after multiple adjustment, in IGTs but not in poorly-controlled T2Ds (of whom49% were hypertensive).

Conclusion: In NGT, IGT orwell-controlled T2D overweight patients, lower vagal activity may contribute to hypertension independently from glycemic status, and FFA may reduce vagal activity and enhance sympathetic activity and thus promote hypertension while in poorly-controlled T2Ds this profile is more likely related to long-term hyperglycemia.

Disclosure

A. Rezki: None. M. Fysekidis: None. E. Cosson: Board Member; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., LifeScan, Inc., Lilly Diabetes, Medtronic, Merck Sharp & Dohme Corp., Novartis France, Novo Nordisk A/S, Roche Diagnostics France, Sanofi. Research Support; Self; Air Liquide, Lilly Diabetes, Novo Nordisk A/S, Roche Diagnostics France, Roche Foundation, Sanofi. P. Valensi: None.
2440-PUB: Characterization of Cardiometabolic Risk Profiles of Individuals Presenting to an Urban Medical Center in Cambodia with Prediabetes and T2DM
Authors: HAAS ANDREA , PENG SOVANN , MENH PHANAVARINE , CURRAN PETER G. , HUDSON MARGO
Published: June 2019

Introduction: The prevalence of prediabetes and T2DM is increasing globally, and especially in developing countries like Cambodia. Comparisons between metabolic risk profiles of patients with prediabetes and T2DM in Cambodia have not previously been reported.

Aims: To compare the clinical characteristics of patients with newly diagnosed prediabetes and T2DM who presented to the Community Medical Center in Phnom Penh, Cambodia. A secondary aim was to determine if any sex differences exist among individuals with T2DM.

Methods: A retrospective study of 763 patients diagnosed with prediabetes or T2DM from July 2015 to July 2018 who had a complete biophysical profile. Comparisons were performed between groups using unpaired Student’s t-test.

Results: Results are summarized in Table 1. Individuals with prediabetes had lower TG levels but otherwise had similar cardiometabolic risk profiles to those with T2DM. Females compared to males with T2DM presented with lower HbA1c levels, but with higher corrected waist circumferences, higher LDL, and a greater number of cardiometabolic risk factors.

Conclusion: Cardiometabolic risk profiles were nearly indistinguishable in those with newly diagnosed prediabetes and T2DM. While females with T2DM presented with lower HbA1c values, they had a greater number of cardiometabolic risk factors compared to males.

Disclosure

A. Haas: None. S. Peng: None. P. Menh: None. P.G. Curran: None. M. Hudson: None.

Funding

National Institutes of Health