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  • 1
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    Online Resource
    Semaglutide and NYHA Functional Class in Obesity-Related Heart Failure With Preserved Ejection Fraction
    Elsevier BV ; 2024
    In:  Journal of the American College of Cardiology Vol. 84, No. 3 ( 2024-07), p. 247-257
    Details
    In: Journal of the American College of Cardiology, Elsevier BV, Vol. 84, No. 3 ( 2024-07), p. 247-257
    Type of Medium: Online Resource
    ISSN: 0735-1097
    URL: Article
    DOI: 10.1016/j.jacc.2024.04.038
    RVK:
    XA 17760
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2024
    detail.hit.zdb_id: 605507-2
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  • 2
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    Postprandial incretin and islet hormone responses and dipeptidyl-peptidase 4 enzymatic activity in patients with maturity onset diabetes of the young
    Oxford University Press (OUP) ; 2015
    In:  European Journal of Endocrinology Vol. 173, No. 2 ( 2015-08), p. 205-215
    Details
    In: European Journal of Endocrinology, Oxford University Press (OUP), Vol. 173, No. 2 ( 2015-08), p. 205-215
    Abstract: The role of the incretin hormones in the pathophysiology of maturity onset diabetes of the young (MODY) is unclear. Design We studied the postprandial plasma responses of glucagon, incretin hormones (glucagon-like peptide 1 (GLP1) and glucose-dependent insulinotropic polypeptide (GIP)) and dipeptidyl-peptidase 4 (DPP4) enzymatic activity in patients with glucokinase (GCK) diabetes (MODY2) and hepatocyte nuclear factor 1α (HNF1A) diabetes (MODY3) as well as in matched healthy individuals (CTRLs). Subjects and methods Ten patients with MODY2 (mean age± s.e.m. 43±5 years; BMI 24±2 kg/m 2 ; fasting plasma glucose (FPG) 7.1±0.3 mmol/l: HbA1c 6.6±0.2%), ten patients with MODY3 (age 31±3 years; BMI 24±1 kg/m 2 ; FPG 8.9±0.8 mmol/l; HbA1c 7.0±0.3%) and ten CTRLs (age 40±5 years; BMI 24±1 kg/m 2 ; FPG 5.1±0.1 mmol/l; HbA1c 5.3±0.1%) were examined with a liquid test meal. Results All of the groups exhibited similar baseline values of glucagon (MODY2: 7±1 pmol/l; MODY3: 6±1 pmol/l; CTRLs: 8±2 pmol/l, P =0.787), but patients with MODY3 exhibited postprandial hyperglucagonaemia (area under the curve (AUC) 838±108 min×pmol/l) as compared to CTRLs (182±176 min×pmol/l, P =0.005) and tended to have a greater response than did patients with MODY2 (410±154 min×pmol/l, P =0.063). Similar peak concentrations and AUCs for plasma GIP and plasma GLP1 were observed across the groups. Increased fasting DPP4 activity was seen in patients with MODY3 (17.7±1.2 mU/ml) vs CTRLs (13.6±0.8 mU/ml, P =0.011), but the amount of activity was similar to that in patients with MODY2 (15.0±0.7 mU/ml, P =0.133). Conclusion The pathophysiology of MODY3 includes exaggerated postprandial glucagon responses and increased fasting DPP4 enzymatic activity but normal postprandial incretin responses both in patients with MODY2 and in patients with MODY3.
    Type of Medium: Online Resource
    ISSN: 0804-4643 , 1479-683X
    URL: Article
    DOI: 10.1530/EJE-15-0070
    RVK:
    WA 15000
    Language: Unknown
    Publisher: Oxford University Press (OUP)
    Publication Date: 2015
    detail.hit.zdb_id: 1183856-5
    detail.hit.zdb_id: 1485160-X
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  • 3
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    2187-PUB: Identifying Risk Predictors for Gastrointestinal Adverse Events with Once-Weekly Semaglutide
    American Diabetes Association ; 2020
    In:  Diabetes Vol. 69, No. Supplement_1 ( 2020-06-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 69, No. Supplement_1 ( 2020-06-01)
    Abstract: Gastrointestinal adverse events (GI AEs) are common with glucagon-like peptide-1 receptor agonists (GLP-1RAs). We aimed to identify risk predictors for GI AEs with once-weekly semaglutide to support clinicians identify high-risk patients. Data from SUSTAIN 1-10 and two SUSTAIN Japanese trials were used to assess the effects of age, region, ethnicity, diabetes duration, gender, renal function, smoking status, HbA1c, body weight (BW), alanine aminotransferase and bilirubin on the incidence of GI AEs with semaglutide vs. non-GLP-1RA comparators (exenatide extended release, dulaglutide and liraglutide were excluded). Changes in HbA1c and BW were assessed by GI AE status. Frailty (age, renal impairment, smoking) and female gender were associated with marginally higher risk of GI AEs than non-frailty and male gender, regardless of treatment. With semaglutide, patients with lower baseline BW were at higher risk of GI AEs vs. those with higher BW. With comparators, lower baseline BW was associated with lower risk than higher BW. These results were confirmed by formal statistical analysis (data not shown). Semaglutide reduced HbA1c and BW across the trials, regardless of GI AEs (Figure). In conclusion, GI AEs are hard to predict although they tend to be more common in frail vs. non-frail patients and females vs. males, regardless of treatment. Semaglutide reduced HbA1c and BW regardless of the presence/absence of GI AEs. Disclosure 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. S. Harring: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. I. Holst: Employee; Self; Novo Nordisk A/S. 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. K. Kvist: Employee; Self; Novo Nordisk A/S. I. Lingvay: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., MannKind Corporation, Novo Nordisk A/S, Sanofi, TARGET PharmaSolutions, Valeritas, Inc. Other Relationship; Self; Novo Nordisk A/S. Funding Novo Nordisk A/S
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db20-2187-PUB
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
    detail.hit.zdb_id: 80085-5
    detail.hit.zdb_id: 1501252-9
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  • 4
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    2160-PUB: Development of an Evidence-Based Tool to Facilitate Individualized Treatment in the Clinic for Patients with Type 2 Diabetes
    American Diabetes Association ; 2020
    In:  Diabetes Vol. 69, No. Supplement_1 ( 2020-06-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 69, No. Supplement_1 ( 2020-06-01)
    Abstract: Type 2 diabetes (T2D) is a heterogeneous disease with many therapies available. Current guidelines recommend individualized therapy, and this could be facilitated by using estimates of outcomes based on individual characteristics instead of population-level outcomes. There are challenges to defining and implementing individualized therapy in a data-driven and patient-oriented way. We propose criteria to aid implementation of individualized medicine, including: 1) robust insights based on high-quality clinical data, to guide treatment selection; 2) integration of patient-oriented outcomes with engagement of providers and patients; 3) provision of a user-friendly, efficient tool for use in the clinic. We are developing an interactive tool that draws on data from a wide range of randomized controlled trials, e.g., all treatment arms from the full phase 3a program for once-weekly semaglutide. The tool selects the appropriate trial from a database and shows the predicted change in outcomes on initiation/continuation with different therapies over 26-30 weeks. Estimates are based on characteristics such as age, BMI, and T2D duration (Figure). In conclusion, a tool such as this could help clinicians and patients use high-quality, large-scale data from contemporary trials to select individualized treatment regimens. Disclosure A.R. Kahkoska: Other Relationship; Self; Novo Nordisk A/S. J.B. Buse: Consultant; Self; Cirius Therapeutics, CSL Behring, Neurimmune. Research Support; Self; American Diabetes Association, National Institutes of Health, Novo Nordisk A/S, Patient-Centered Outcomes Research Institute, Sanofi, Tolerion, Inc., vTv Therapeutics. Stock/Shareholder; Self; Mellitus Health, Pendulum Therapeutics, PhaseBio Pharmaceuticals, Inc., Stability Health. Other Relationship; Self; ADOCIA, AstraZeneca, Dance Biopharm Holdings, Inc., Eli Lilly and Company, MannKind Corporation, NovaTarg Therapeutics, Novo Nordisk A/S, Senseonics, Inc, vTv Therapeutics, Zafgen, Inc. S. Harring: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. I. Holst: Employee; Self; Novo Nordisk A/S. 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. K. Kvist: Employee; Self; Novo Nordisk A/S. R.E. Pratley: Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Glytec, Janssen Scientific Affairs, LLC., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals Incorporated, Merck & Co., Inc., Novo Nordisk Inc., Sanofi. Funding Novo Nordisk A/S
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db20-2160-PUB
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
    detail.hit.zdb_id: 80085-5
    detail.hit.zdb_id: 1501252-9
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  • 5
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    Online Resource
    1003-P: Clinical Response (HbA1c ≥1% and/or Body Weight ≥5% Reduction) to Semaglutide by Baseline HbA1c and Body Weight in the SUSTAIN Program
    American Diabetes Association ; 2019
    In:  Diabetes Vol. 68, No. Supplement_1 ( 2019-06-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: The SUSTAIN clinical development program assessed semaglutide once weekly, a glucagon-like peptide-1 (GLP-1) analog, across the continuum of type 2 diabetes (T2D) care, including in drug-naïve subjects and those on a background of oral antidiabetic drugs and/or insulin. Semaglutide demonstrated superior reductions in HbA1c and body weight (BW) vs. placebo and comparators (sitagliptin, exenatide extended release, insulin glargine, dulaglutide). This post hoc analysis assessed the proportion of semaglutide-treated subjects achieving clinically relevant responses (composite endpoint: ≥1% HbA1c reduction and ≥5% BW loss; individual components: ≥1% HbA1c or ≥5% BW loss) by baseline HbA1c and BW across SUSTAIN 1-5 and 7. A consistently high proportion of semaglutide-treated subjects achieved clinically relevant responses (composite, 42.0%; ≥1% HbA1c reduction, 76.6%; ≥5% BW loss, 49.9%), regardless of baseline HbA1c and BW (Figure). Baseline HbA1c and BW did not affect the likelihood of achieving the composite and ≥5% BW endpoints. A ≥1% HbA1c reduction was significantly more likely to be achieved with higher baseline HbA1c (143% increased odds per 1% unit higher baseline HbA1c;p & lt;0.0001). Semaglutide provides meaningful reductions in HbA1c and BW across a range of HbA1c and BW. Individuals with poorly controlled HbA1c were more likely to achieve a ≥1% HbA1c reduction. Disclosure V.R. Aroda: Consultant; Self; ADOCIA, AstraZeneca, Becton, Dickinson and Company, Novo Nordisk Inc., Sanofi, Zafgen, Inc. Employee; Spouse/Partner; Merck & Co., Inc. Research Support; Self; AstraZeneca, Calibra Medical, Eisai Inc., Janssen Research & Development, Novo Nordisk Inc., Sanofi, Theracos, Inc. J.F. Larsen: Employee; Self; Novo Nordisk A/S. S.H. Østoft: Employee; Self; Novo Nordisk A/S. R.R. Rea: Other Relationship; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk A/S, Sanofi. D. Sugimoto: Research Support; Self; Gan & Lee Pharmaceuticals, Novo Nordisk A/S, Sanofi. U. Ziegler: Employee; Self; KOEHLER eClinical GmbH, Freiburg im Breisgau, Germany. T. Vilsbøll: None. Funding Novo Nordisk A/S
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db19-1003-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
    detail.hit.zdb_id: 80085-5
    detail.hit.zdb_id: 1501252-9
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  • 6
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    The relationship between HbA1c and hypoglycaemia in patients with diabetes treated with insulin degludec versus insulin glargine 100 units/mL
    Wiley ; 2020
    In:  Diabetes, Obesity and Metabolism Vol. 22, No. 5 ( 2020-05), p. 779-787
    Details
    In: Diabetes, Obesity and Metabolism, Wiley, Vol. 22, No. 5 ( 2020-05), p. 779-787
    Abstract: Treat‐to‐target, randomized controlled trials have confirmed lower rates of hypoglycaemia at equivalent glycaemic control with insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100) in patients with type 1 (T1D) or type 2 diabetes (T2D). Treat‐to‐target trials are designed to enable comparisons of safety and tolerability at a similar HbA1c level. In this post hoc analysis of the SWITCH 1 and 2 trials, we utilised a patient‐level modelling approach to compare how glycaemic control might differ between basal insulins at a similar rate of hypoglycaemia. Materials and Methods Data for HbA1c and symptomatic hypoglycaemia from the SWITCH 1 and SWITCH 2 trials were analyzed separately for patients with type 1 diabetes and type 2 diabetes, respectively. The association between the individual patient‐level risk of hypoglycaemia and HbA1c was investigated using a Poisson regression model and used to estimate potential differences in glycaemic control with degludec versus glargine U100, at the same rate of hypoglycaemia. Results Improvements in glycaemic control increased the incidence of hypoglycaemia with both basal insulins across diabetes types. Our analysis suggests that patients could achieve a mean HbA1c reduction of 0.70 [0.05; 2.20] 95% CI (for type 1 diabetes) or 0.96 [0.39; 1.99] 95% CI (for type 2 diabetes) percentage points (8 [1; 24] 95% CI or 10 [4; 22] 95% CI mmol/mol, respectively) further with degludec than with glargine U100 before incurring an equivalent risk of hypoglycaemia. Conclusion Our findings suggest that patients in clinical practice may be able to achieve lower glycaemia targets with degludec versus glargine U100, before incurring an equivalent risk of hypoglycaemia.
    Type of Medium: Online Resource
    ISSN: 1462-8902 , 1463-1326
    URL: Issue
    URL: Article
    DOI: 10.1111/dom.v22.5
    DOI: 10.1111/dom.13954
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 2004918-3
    detail.hit.zdb_id: 1454944-X
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  • 7
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    Online Resource
    Semaglutide improves health‐related quality of life versus placebo when added to standard of care in patients with type 2 diabetes at high cardiovascular risk ( SUSTAIN 6)
    Wiley ; 2020
    In:  Diabetes, Obesity and Metabolism Vol. 22, No. 8 ( 2020-08), p. 1339-1347
    Details
    In: Diabetes, Obesity and Metabolism, Wiley, Vol. 22, No. 8 ( 2020-08), p. 1339-1347
    Abstract: To assess what drives change in health‐related quality of life (HRQoL) in type 2 diabetes in the SUSTAIN 6 trial and identify potential mediators of the treatment effect of semaglutide on HRQoL scores. Materials and Methods The Short Form (SF)‐36v2® questionnaire [comprising physical component summary (PCS) and mental component summary (MCS)] was used to assess changes in HRQoL from baseline to week 104, by treatment, in a prespecified analysis. This post‐hoc analysis assessed change in PCS and MCS using the following factors as parameter/covariate, using descriptive statistics and linear regressions: major adverse cardiac events, hypoglycaemia, gastrointestinal adverse events, at least one episode of nausea, vomiting or diarrhoea, and change in glycated haemoglobin (HbA1c), body weight, blood pressure, heart rate and estimated glomerular filtration rate. Results Mean change in overall PCS score was +1.0 with semaglutide versus +0.4 with placebo, and +0.5 versus −0.2 for MCS. The treatment effect of semaglutide versus placebo (unadjusted estimate) was 0.7 [(95% confidence interval 0.1, 1.2); P = 0.018] on PCS and this was reduced when adjusted for change in HbA1c [0.4 (−0.2, 1.0), P = .167] and body weight [0.3 (−0.3, 0.9), P = .314]. The unadjusted treatment effect on MCS [0.7 (−0.0, 1.5), P = .054] was only reduced when adjusted for change in HbA1c [0.3 (−0.4, 1.1), P = .397]. When adjusting for all other parameters separately, the estimated effect of semaglutide on PCS and MCS qualitatively did not change. Conclusions Semaglutide improved HRQoL versus placebo; greater improvements with semaglutide versus placebo were possibly mediated, in part, by change in HbA1c and body weight. Clinicaltrials.gov : NCT01720446 (SUSTAIN 6).
    Type of Medium: Online Resource
    ISSN: 1462-8902 , 1463-1326
    URL: Issue
    URL: Article
    DOI: 10.1111/dom.v22.8
    DOI: 10.1111/dom.14039
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 2004918-3
    detail.hit.zdb_id: 1454944-X
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  • 8
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    86 - Clinical Response (HbA1C ≥1% and/or Body Weight ≥5% Reduction) to Semaglutide by Baseline HbA1C and Body Weight in the SUSTAIN Program
    Elsevier BV ; 2019
    In:  Canadian Journal of Diabetes Vol. 43, No. 7 ( 2019-10), p. S31-S32
    Details
    In: Canadian Journal of Diabetes, Elsevier BV, Vol. 43, No. 7 ( 2019-10), p. S31-S32
    Type of Medium: Online Resource
    ISSN: 1499-2671
    URL: Article
    DOI: 10.1016/j.jcjd.2019.07.095
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
    detail.hit.zdb_id: 2205004-8
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  • 9
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    Online Resource
    No detectable effect of a type 2 diabetes-associated TCF7L2 genotype on the incretin effect
    Bioscientifica ; 2020
    In:  Endocrine Connections Vol. 9, No. 12 ( 2020-12), p. 1221-1232
    Details
    In: Endocrine Connections, Bioscientifica, Vol. 9, No. 12 ( 2020-12), p. 1221-1232
    Abstract: The T allele of TCF7L2 rs7903146 is a common genetic variant associated with type 2 diabetes (T2D), possibly by modulation of incretin action. In this study, we evaluated the effect of the TCF7L2 rs7903146 T allele on the incretin effect and other glucometabolic parameters in normal glucose tolerant individuals (NGT) and participants with T2D. The rs7903146 variant was genotyped in cohorts of 61 NGT individuals (23 were heterozygous (CT) or homozygous (TT) T allele carriers) and 43 participants with T2D (20 with CT/TT). Participants were previously examined by an oral glucose tolerance test (OGTT) and a subsequent isoglycemic intravenous glucose infusion (IIGI). The incretin effect was assessed by quantification of the difference in integrated beta cell secretory responses during the OGTT and IIGI. Glucose and hormonal levels were measured during experimental days, and from these, indices of beta cell function and insulin sensitivity were calculated. No genotype-specific differences in the incretin effect were observed in the NGT group ( P  = 0.70) or the T2D group ( P =  0.68). NGT T allele carriers displayed diminished glucose-dependent insulinotropic polypeptide response during OGTT ( P  = 0.01) while T allele carriers with T2D were characterized by lower C-peptide AUC after OGTT ( P  = 0.04) and elevated glucose AUC after OGTT ( P  = 0.04). In conclusion, our findings do not exclude that this specific TCF7L2 variant increases the risk of developing T2D via diminished incretin effect, but genotype-related defects were not detectable in these cohorts.
    Type of Medium: Online Resource
    ISSN: 2049-3614
    URL: Article
    DOI: 10.1530/EC-20-0471
    Language: Unknown
    Publisher: Bioscientifica
    Publication Date: 2020
    detail.hit.zdb_id: 2668428-7
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