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1

Pharmacokinetics and Pharmacodynamics of Exenatide Extended-Release After Single and Multiple Dosing

Mark Fineman, Shawn Flanagan, Kristin Taylor, Maria Aisporna, Larry Z. Shen, Kenneth F. Mace, Brandon Walsh, Michaela Diamant, Brenda Cirincione, Prajakti Kothare, Wen-I Li, Leigh MacConell

Journal:

Clinical Pharmacokinetics

Year:

2011

Language:

english

File:

PDF, 196 KB

english, 2011

2

GLOBAL COMPETITION IN THE'90s

Costa, Maria Cristina Monteiro S., Carvalho, Luciana, Leal, Cintia Dutra, Dias, Marcela França, Martins, Karoline L., Garcia, Guilherme Brugger, Mancuelo, Isabella Daldegan, Hipólito, Thais, MacConell

Journal:

Journal of Applied Corporate Finance

Year:

1993

Language:

english

File:

PDF, 960 KB

english, 1993

3

Effect of exenatide on heart rate and blood pressure in subjects with type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study

Anne Gill, Byron J Hoogwerf, Jude Burger, Simon Bruce, Leigh MacConell, Ping Yan, Daniel Braun, Joseph Giaconia, James Malone

Journal:

Cardiovascular Diabetology

Year:

2010

Language:

english

File:

PDF, 403 KB

english, 2010

4

Effects of haloperidol in a response-reinstatement model of heroin relapse

A. Ettenberg, L. A. MacConell, T. D. Geist

Journal:

Psychopharmacology

Year:

1996

Language:

english

File:

PDF, 922 KB

english, 1996

5

Betaglycan binds inhibin and can mediate functional antagonism of activin signalling

Lewis, Kathy A., Gray, Peter C., Blount, Amy L., MacConell, Leigh A., Wiater, Ezra, Bilezikjian, Louise M., Vale, Wylie

Journal:

Year:

2000

Language:

english

File:

PDF, 288 KB

english, 2000

6

Expression of activin and follistatin in the rat hypothalamus

Leigh A. MacConell, Amy E. Widger, Sara Barth-Hall, Veronica J. Roberts

Journal:

Endocrine (Springer)

Year:

1998

Language:

english

File:

PDF, 450 KB

english, 1998

7

Effects of exenatide versus sitagliptin on postprandial glucose, insulin and glucagon secretion, gastric emptying, and caloric intake: a randomized, cross-over study

MacConell, Leigh, DeFronzo, Ralph A., Okerson, Ted, Viswanathan, Prabhakar, Guan, Xuesong, Holcombe, John H.

Journal:

Current Medical Research and Opinion

Year:

2008

Language:

english

File:

PDF, 172 KB

english, 2008

8

Adenovirus-mediated overexpression of follistatin enlarges intact liver of adult rats

Kazuaki Takabe, Lili Wang, Angela M.O. Leal, Leigh A. MacConell, Ezra Wiater, Tomoaki Tomiya, Akihiko Ohno, Inder M. Verma, Wylie Vale

Journal:

Year:

2003

Language:

english

File:

PDF, 279 KB

english, 2003

9

Effects of Once-Weekly Dosing of a Long-Acting Release Formulation of Exenatide on Glucose Control and Body Weight in Subjects With Type 2 Diabetes

Kim, D., MacConell, L., Zhuang, D., Kothare, P. A., Trautmann, M., Fineman, M., Taylor, K.

Journal:

Year:

2007

Language:

english

File:

PDF, 388 KB

english, 2007

10

Safety and Efficacy of Once-Weekly Exenatide Compared With Insulin Glargine Titrated to Target in Patients With Type 2 Diabetes Over 84 Weeks

Diamant, M., Van Gaal, L., Stranks, S., Guerci, B., MacConell, L., Haber, H., Scism-Bacon, J., Trautmann, M.

Journal:

Year:

2012

Language:

english

File:

PDF, 740 KB

english, 2012

11

Long-Term Effects of Adding Exenatide to a Regimen of Metformin and/or Sulfonylurea in Type 2 Diabetes: An Uncontrolled, Open-Label Trial in Hungary

Tibor Iványi, József Fövényi, Péter Faludi, Jenny Han, Leigh MacConell, Simone Wille, Jacek Kiljanski

Journal:

Clinical Therapeutics

Year:

2012

Language:

english

File:

PDF, 566 KB

english, 2012

12

Comparison of safety and tolerability with continuous (exenatide once weekly) or intermittent (exenatide twice daily) GLP-1 receptor agonism in patients with type 2 diabetes

T. Ridge, T. Moretto, L. MacConell, R. Pencek, J. Han, C. Schulteis, L. Porter

Journal:

Diabetes, Obesity and Metabolism

Year:

2012

Language:

english

File:

PDF, 553 KB

english, 2012

13

Opposite effects of prefrontal cortex and nucleus accumbens infusions of flupenthixol on stimulant-induced locomotion and brain stimulation reward

Christine L. Duvauchelle, Mark Levitin, Leigh A. MacConell, Linda K. Lee, Aaron Ettenberg

Journal:

Year:

1992

Language:

english

File:

PDF, 734 KB

english, 1992

14

Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug—naive patients with type 2 diabetes: A randomized, double-blind, placebo-controlled, parallel-group study

Thomas J. Moretto, Denái R. Milton, Terry D. Ridge, Leigh A. MacConell, Ted Okerson, Anne M. Wolka, Robert G. Brodows

Journal:

Clinical Therapeutics

Year:

2008

Language:

english

File:

PDF, 908 KB

english, 2008

15

Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial

Richard M Bergenstal, Carol Wysham, Leigh MacConell, Jaret Malloy, Brandon Walsh, Ping Yan, Ken Wilhelm, Jim Malone, Lisa E Porter

Journal:

Year:

2010

Language:

english

File:

PDF, 399 KB

english, 2010

16

PO33 Tolérance et sécurité de l’exénatide administré 2x/j chez des patients diabétiques de type 2 : analyse de 3 854 patients issus de 11 études cliniques contrôlées vs comparateurs

S. Bruce, L. Macconell, C. Brown, C. Bonnard, C. Salaun-Martin, J. Han, D. Nicewarner, T. Okerson, D.K. Braun, G. Bloomgren

Journal:

Diabetes & Metabolism

Year:

2010

Language:

french

File:

PDF, 72 KB

french, 2010

17

P300 DURATION-3 : Modifications des facteurs de risque cardiovasculaires chez des patients diabétiques de type 2, après 84 semaines de traitement par exénatide hebdomadaire ou insuline glargine

M. Diamant, L. VanGaal, S. Stranks, B. Guerci, L. MacConell, M. Chan, M. Trautmann

Journal:

Diabetes & Metabolism

Year:

2012

Language:

french

File:

PDF, 66 KB

french, 2012

18

Pimozide prevents the development of conditioned place preferences induced by rewarding locus coeruleus stimulation

Christine L. Duvauchelle, Leigh A. MacConell, Alex D. Eremia, Aaron Ettenberg

Journal:

Behavioural Brain Research

Year:

1992

Language:

english

File:

PDF, 675 KB

english, 1992

19

Addition of exenatide BID to insulin glargine: a post-hoc analysis of the effect on glycemia and weight across a range of insulin titration

Buse, John B., Han, Jenny, Miller, Stephan, MacConell, Leigh, Pencek, Richard, Wintle, Matthew

Journal:

Current Medical Research and Opinion

Year:

2014

Language:

english

File:

PDF, 411 KB

english, 2014

20

P377 THE FXR AGONIST OBETICHOLIC ACID IMPROVES A TRANSPLANT-FREE SURVIVAL-PROVEN BIOCHEMICAL RESPONSE CRITERION IN PLACEBO CONTROLLED PRIMARY BILIARY CIRRHOSIS STUDIES

Luketic, V., Gordon, S.G., Vincent, C., Chapman, R., Mayo, M., Kowdley, K., Hirschfield, G., Mason, A., Lindor, K., Macconell, L., Marmon, T., Hooshmand-Rad, R., Shapiro, D.

Journal:

Journal of Hepatology

Year:

2014

Language:

english

File:

PDF, 122 KB

english, 2014

21

Encapsulation of Exenatide in Poly-( d,l -Lactide-Co-Glycolide) Microspheres Produced an Investigational Long-Acting Once-Weekly Formulation for Type 2 Diabetes

DeYoung, Mary Beth, MacConell, Leigh, Sarin, Viren, Trautmann, Michael, Herbert, Paul

Journal:

Diabetes Technology & Therapeutics

Year:

2011

Language:

english

File:

PDF, 738 KB

english, 2011

22

Is insulin the most effective injectable antihyperglycaemic therapy?

Buse, J. B., Peters, A., Russell-Jones, D., Furber, S., Donsmark, M., Han, J., MacConell, L., Maggs, D., Diamant, M.

Journal:

Diabetes, Obesity and Metabolism

Year:

2015

Language:

english

File:

PDF, 1.17 MB

english, 2015

23

Exenatide at therapeutic and supratherapeutic concentrations does not prolong the QT c interval in healthy subjects

Darpö, Börje, Philip, Sager, MacConell, Leigh, Cirincione, Brenda, Mitchell, Malcolm, Han, Jenny, Huang, Wenying, Malloy, Jaret, Schulteis, Christine, Shen, Larry, Porter, Lisa

Journal:

British Journal of Clinical Pharmacology

Year:

2013

Language:

english

File:

PDF, 1.63 MB

english, 2013

24

Impact of inocula and operating conditions on the microbial community structure of two anammox reactors

Costa, Maria Cristina Monteiro S., Carvalho, Luciana, Leal, Cintia Dutra, Dias, Marcela França, Martins, Karoline L., Garcia, Guilherme Brugger, Mancuelo, Isabella Daldegan, Hipólito, Thais, MacConell

Journal:

Environmental Technology

Year:

2014

Language:

english

File:

PDF, 570 KB

english, 2014

25

Five-Year Efficacy and Safety Data of Exenatide Once Weekly

Wysham, Carol H., MacConell, Leigh A., Maggs, David G., Zhou, Ming, Griffin, Peter S., Trautmann, Michael E.

Journal:

Mayo Clinic Proceedings

Year:

2015

Language:

english

File:

PDF, 500 KB

english, 2015

26

Glucagon-Like Peptide 1 Receptor Agonist or Bolus Insulin With Optimized Basal Insulin in Type 2 Diabetes

Diamant, Michaela, Nauck, Michael A., Shaginian, Rimma, Malone, James K., Cleall, Simon, Reaney, Matthew, de Vries, Danielle, Hoogwerf, Byron J., MacConell, Leigh, Wolffenbuttel, Bruce H.R.

Journal:

Year:

2014

Language:

english

File:

PDF, 1.17 MB

english, 2014

27

1.6 Exenatide BID vs. Insulin Lispro TIDM Added to Titrated Insulin Glargine QD in Metformin-Treated T2DM Patients Resulted in Similar Glycemic Control but Weight Loss and Less Hypoglycemia: The 4B Study (70-OR)

Diamant, Michaela, Nauck, Michael, Shaginian, Rimma, Malone, James, Cleall, Simon, de Vries, Daniëlle, Hoogwerf, Byron J., Macconell, Leigh, Wolffenbuttel, Bruce

Journal:

Nederlands Tijdschrift voor Diabetologie

Year:

2013

File:

PDF, 87 KB

2013

28

Association among weight change, glycemic control, and markers of cardiovascular risk with exenatide once weekly: a pooled analysis of patients with type 2 diabetes

Blonde, Lawrence, Pencek, Richard, MacConell, Leigh

Journal:

Cardiovascular Diabetology

Year:

2015

Language:

english

File:

PDF, 684 KB

english, 2015

29

Baseline Factors Associated With Glycemic Control and Weight Loss When Exenatide Twice Daily Is Added to Optimized Insulin Glargine in Patients With Type 2 Diabetes

Rosenstock, J., Shenouda, S. K., Bergenstal, R. M., Buse, J. B., Glass, L. C., Heilmann, C. R., Kwan, A. Y. M., MacConell, L. A., Hoogwerf, B. J.

Journal:

Year:

2012

Language:

english

File:

PDF, 412 KB

english, 2012

30

P1155 : FXR Agonism with obeticholic acid may attenuate bone mineral density decrease in subjects with primary biliary cirrhosis

Pares, A., Pencek, R., Peters, Y., Marmon, T., MacConell, L., Adorini, L., Shapiro, D., Trauner, M., Jones, D.

Journal:

Journal of Hepatology

Year:

2015

Language:

english

File:

PDF, 43 KB

english, 2015

31

Neuron-Specific Expression in Vivo by Defined Transcription Regulatory Elements of the GnRH Gene

Lawson, Mark A., Macconell, Leigh A., Kim, Jinah, Powl, Brian T., Nelson, Shelley B., Mellon, Pamela L.

Journal:

Year:

2002

Language:

english

File:

PDF, 395 KB

english, 2002

32

The Distribution of Betaglycan Protein and mRNA in Rat Brain, Pituitary, and Gonads: Implications for a Role for Betaglycan in Inhibin-Mediated Reproductive Functions

MacConell, Leigh A., Leal, Angela M. O., Vale, Wylie W.

Journal:

Year:

2002

Language:

english

File:

PDF, 1.26 MB

english, 2002

33

Effect of Adenovirus-Mediated Overexpression of Follistatin and Extracellular Domain of Activin Receptor Type II on Gonadotropin Secretion in Vitro and in Vivo

Leal, Angela M. O., Takabe, Kazuaki, Wang, Lili, Donaldson, Cynthia J., MacConell, Leigh A., Bilezikjian, Louise M., Verma, Inder M., Vale, Wylie

Journal:

Year:

2002

Language:

english

File:

PDF, 244 KB

english, 2002

34

OC.06.8 INTEGRATED ANALYSIS OF EFFICACY OF PHASE II AND III DATA OF OBETICHOLIC ACID IN PBC SUBPOPULATIONS BASED ON AGE AND SEX

Pencek, R., Lutz, K., Marmon, T., Macconell, L., Picaro, L.A., Adorini, L., Shapiro, D.

Journal:

Digestive and Liver Disease

Year:

2016

Language:

english

File:

PDF, 331 KB

english, 2016

35

OC.12.8 LONG-TERM SAFETY OF OBETICHOLIC ACID IN PATIENTS WITH PRIMARY BILIARY CIRRHOSIS

Peters, Y., Hooshmand-rad, R., Pencek, R., Owens-grillo, J., Marmon, T., Macconell, L., Picaro, L.A., Adorini, L., Shapiro, D.

Journal:

Digestive and Liver Disease

Year:

2016

Language:

english

File:

PDF, 63 KB

english, 2016

36

P1321 : A phase 3B, double blind, placebo controlled study evaluating the effect of obeticholic acid on clinical outcomes in subjects with primary biliary cirrhosis at elevated risk of progression to liver transplant or death

Lindor, K., Hansen, B., Pencek, R., Hooshmand-Rad, R., Marmon, T., MacConell, L., Shapiro, D., Jones, D.

Journal:

Journal of Hepatology

Year:

2015

Language:

english

File:

PDF, 464 KB

english, 2015

37

OC.06.1 ANALYSIS OF THE EFFICACY OF OCA IN PRIMARY BILIARY CIRRHOSIS BY VARYING PATIENT DISEASE SEVERITY ACROSS THREE RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIALS

Lutz, K., Pencek, R., Marmon, T., Macconell, L., Picaro, L.A., Adorini, L., Shapiro, D.

Journal:

Digestive and Liver Disease

Year:

2016

Language:

english

File:

PDF, 240 KB

english, 2016

38

P1137 : Integrated efficacy summary for obeticholic acid in subjects with primary biliary cirrhosis

Invernizzi, P., Pencek, R., Marmon, T., MacConell, L., Shapiro, D.

Journal:

Journal of Hepatology

Year:

2015

Language:

english

File:

PDF, 43 KB

english, 2015

39

Efficacy and Safety of Multiple Doses of Exenatide Once-Monthly Suspension in Patients With Type 2 Diabetes: A Phase 2 Randomized Clinical Trial

Wysham, Carol H., MacConell, Leigh, Hardy, Elise

Journal:

Year:

2016

Language:

english

File:

PDF, 1.15 MB

english, 2016

40

A Multicenter, Randomized, Open Label, Single- and Multiple-Dose, Dose Finding Study and Open-Label Extension to Assess the Effects of Obeticholic Acid in Pediatric Patients with Biliary Atresia

Karpen, S., Eliot, L., Scholz, B., Joshi, M.M., Merrigan, M.M., Sciacca, C., Marmon, T., Hooshmand-Rad, R., MacConell, L., Shapiro, D.

Journal:

Journal of Hepatology

Year:

2016

Language:

english

File:

PDF, 75 KB

english, 2016

41

Regenerate: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Multicenter Study of Obeticholic Acid Therapy for Nonalcoholic Steatohepatitis

Ratziu, V., Sanyal, A.J., MacConell, L., Shringarpure, R., Marmon, T., Shapiro, D., Younossi, Z.M.

Journal:

Journal of Hepatology

Year:

2016

Language:

english

File:

PDF, 125 KB

english, 2016

42

Distribution of follistatin messenger ribonucleic acid in the rat brain: implications for a role in the regulation of central reproductive functions.

Macconell, L A, Barth, S, Roberts, V J

Journal:

Year:

1996

Language:

english

File:

PDF, 4.94 MB

english, 1996

43

Durable response in the markers of cholestasis through 24 months of open-label extension with obeticholic acid in Italian patients with primary biliary cholangitis

Andreone, P., Floreani, A., Invernizzi, P., Mazzella, G., Owens-Grillo, J., Smoot Malecha, E., MacConell, L.

Journal:

Digestive and Liver Disease

Year:

2017

Language:

english

File:

PDF, 50 KB

english, 2017

44

PC.01.3: Efficacy and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis: An Analysis of the Italian Patients from a Phase 3, Randomized, Placebo-Controlled Study

Floreani, A., Andreone, P., Invernizzi, P., Mazzella, G., Owens-Grillo, J., Smoot Malecha, E., Macconell, L.

Journal:

Digestive and Liver Disease

Year:

2017

Language:

english

File:

PDF, 829 KB

english, 2017

45

Risk reduction with obeticholic acid in patients not achieving the POISE primary endpoint

Harms, M., Carbone, M., Hansen, B., Mells, G., Pencek, R., Smoot-Malecha, E., MacConell, L.

Journal:

Journal of Hepatology

Year:

2017

Language:

english

File:

PDF, 78 KB

english, 2017

46

Assessment of Pharmacokinetic Interactions Between Obeticholic Acid and Caffeine, Midazolam, Warfarin, Dextromethorphan, Omeprazole, Rosuvastatin, and Digoxin in Phase 1 Studies in Healthy Subjects

Edwards, Jeffrey E., Eliot, Lise, Parkinson, Andrew, Karan, Sharon, MacConell, Leigh

Journal:

Advances in Therapy

Year:

2017

Language:

english

File:

PDF, 1.77 MB

english, 2017

47

[BMJ Publishing Group Ltd and British Society of Gastroenterology British Society of Gastroenterology, Annual General Meeting, 19–22 June 2017, Abstracts - ()] Liver - PTU-100 Efficacy of obeticholic acid treatment in patients with primary biliary cholangitis with cirrhosis

Vierling, JM, Hirschfield, G, Jones, DE, Groszmann, R, Kowdley, KV, Pencek, R, Marmon, T, MacConell, L

Language:

english

File:

PDF, 122 KB

english

48

Durable response in the markers of cholestasis through 36 months of open-label extension with obeticholic acid in Italian patients with primary biliary cholangitis

Andreone, P., Floreani, A., Invernizzi, P., Mazzella, G., Owens-Grillo, J., Malecha, E. Smoot, MacConell, L.

Journal:

Digestive and Liver Disease

Year:

2018

Language:

english

File:

PDF, 48 KB

english, 2018

49

PC.01.8 THE AESOP TRIAL: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY OF OBETICHOLIC ACID IN PATIENTS WITH PRIMARY SCLEROSING CHOLANGITIS

Larusso, N.F., Bowlus, C.L., Levy, C., Vuppalanchi, R., Floreani, A., Andreone, P., Srestha, R., Trotter, J., Goldberg, D., Rushbrook, S., Hirschfield, G.M., Van Biene, C., Penceck, R., Macconell, L.,

Journal:

Digestive and Liver Disease

Year:

2018

Language:

english

File:

PDF, 317 KB

english, 2018

50

Clinical application of the GLOBE and United Kingdom-primary biliary cholangitis risk scores in a trial cohort of patients with primary biliary cholangitis

Carbone, Marco, Harms, Maren H., Lammers, Willem J., Marmon, Tonya, Pencek, Richard, MacConell, Leigh, Shapiro, David, Jones, David E., Mells, George F., Hansen, Bettina E.

Journal:

Hepatology Communications

Year:

2018

Language:

english

File:

PDF, 497 KB

english, 2018