Skip to main content
  • More from ADA
    • Diabetes
    • Clinical Diabetes
    • Diabetes Spectrum
    • ADA Standards of Medical Care
    • ADA Scientific Sessions Abstracts
    • BMJ Open Diabetes Research & Care
  • Subscribe
  • Log in
  • My Cart
  • Follow ada on Twitter
  • RSS
  • Visit ada on Facebook
Diabetes Care

Advanced Search

Main menu

  • Home
  • Current
    • Current Issue
    • Online Ahead of Print
    • Special Article Collections
    • ADA Standards of Medical Care
  • Browse
    • By Topic
    • Issue Archive
    • Saved Searches
    • Special Article Collections
    • ADA Standards of Medical Care
  • Info
    • About the Journal
    • About the Editors
    • ADA Journal Policies
    • Instructions for Authors
    • Guidance for Reviewers
  • Reprints/Reuse
  • Advertising
  • Subscriptions
    • Individual Subscriptions
    • Institutional Subscriptions and Site Licenses
    • Access Institutional Usage Reports
    • Purchase Single Issues
  • Alerts
    • E­mail Alerts
    • RSS Feeds
  • Podcasts
    • Diabetes Core Update
    • Special Podcast Series: Therapeutic Inertia
    • Special Podcast Series: Influenza Podcasts
    • Special Podcast Series: SGLT2 Inhibitors
    • Special Podcast Series: COVID-19
  • Submit
    • Submit a Manuscript
    • Journal Policies
    • Instructions for Authors
    • ADA Peer Review
  • More from ADA
    • Diabetes
    • Clinical Diabetes
    • Diabetes Spectrum
    • ADA Standards of Medical Care
    • ADA Scientific Sessions Abstracts
    • BMJ Open Diabetes Research & Care

User menu

  • Subscribe
  • Log in
  • My Cart

Search

  • Advanced search
Diabetes Care
  • Home
  • Current
    • Current Issue
    • Online Ahead of Print
    • Special Article Collections
    • ADA Standards of Medical Care
  • Browse
    • By Topic
    • Issue Archive
    • Saved Searches
    • Special Article Collections
    • ADA Standards of Medical Care
  • Info
    • About the Journal
    • About the Editors
    • ADA Journal Policies
    • Instructions for Authors
    • Guidance for Reviewers
  • Reprints/Reuse
  • Advertising
  • Subscriptions
    • Individual Subscriptions
    • Institutional Subscriptions and Site Licenses
    • Access Institutional Usage Reports
    • Purchase Single Issues
  • Alerts
    • E­mail Alerts
    • RSS Feeds
  • Podcasts
    • Diabetes Core Update
    • Special Podcast Series: Therapeutic Inertia
    • Special Podcast Series: Influenza Podcasts
    • Special Podcast Series: SGLT2 Inhibitors
    • Special Podcast Series: COVID-19
  • Submit
    • Submit a Manuscript
    • Journal Policies
    • Instructions for Authors
    • ADA Peer Review
Emerging Treatments and Technologies

Effects of Exenatide (Exendin-4) on Glycemic Control Over 30 Weeks in Patients With Type 2 Diabetes Treated With Metformin and a Sulfonylurea

  1. David M. Kendall, MD1,
  2. Matthew C. Riddle, MD2,
  3. Julio Rosenstock, MD3,
  4. Dongliang Zhuang, PHD4,
  5. Dennis D. Kim, MD4,
  6. Mark S. Fineman, BS4 and
  7. Alain D. Baron, MD4
  1. 1International Diabetes Center and University of Minnesota, Minneapolis, Minnesota
  2. 2Section of Diabetes, Oregon Health & Science University, Portland, Oregon
  3. 3Dallas Diabetes and Endocrine Center, Dallas, Texas
  4. 4Amylin Pharmaceuticals, San Diego, California
  1. Address correspondence and reprint requests to Alain D. Baron, MD, Senior Vice President, Research, Amylin Pharmaceuticals, 9360 Towne Centre Dr., Suite 110, San Diego, CA 92121. E-mail: abaron{at}amylin.com
Diabetes Care 2005 May; 28(5): 1083-1091. https://doi.org/10.2337/diacare.28.5.1083
PreviousNext
  • Article
  • Figures & Tables
  • Info & Metrics
  • PDF
Loading

Article Figures & Tables

Figures

  • Tables
  • Figure 1—
    • Download figure
    • Open in new tab
    • Download powerpoint
    Figure 1—

    Protocol flow chart. One subject was randomized twice. Both screening numbers were counted in the randomized population, but only one was counted in the ITT population. Subjects in the 10-μg exenatide b.i.d. arm received 5 μg exenatide b.i.d. during weeks 0–4. Subjects in all treatment arms were maintained on metformin and a sulfonylurea. Data are means ± SD.

  • Figure 2—
    • Download figure
    • Open in new tab
    • Download powerpoint
    Figure 2—

    Glycemic control in subjects with type 2 diabetes treated with metformin and a sulfonylurea plus exenatide or placebo (ITT population) A: A1C values over the course of the study (raw data). B: Change in A1C over 30 weeks. *Adjusted P < 0.0001 compared with placebo. Week 30 changes in A1C values from baseline were −0.77 ± 0.08% (10-μg arm; adjusted P < 0.0001 vs. placebo), −0.55 ± 0.07% (5-μg arm; adjusted P < 0.0001 vs. placebo), and +0.23 ± 0.07% (placebo arm). C: Week 30 change in A1C stratified by baseline A1C. For subjects with baseline A1C <9%, baseline A1C values were 7.92 ± 0.04% (n = 169), 7.91 ± 0.04% (n = 172), and 7.94 ± 0.04% (n = 172) for the 10-μg exenatide, 5-μg exenatide, and placebo arms, respectively. The corresponding values for subjects with baseline A1C ≥9% were 9.86 ± 0.07% (n = 72), 9.75 ± 0.07% (n = 73), and 9.75 ± 0.07% (n = 75). D: Effects of exenatide on body weight. Subjects in the 10-μg exenatide b.i.d. treatment arm received 5 μg exenatide b.i.d. during weeks 0–4. Subjects in all treatment arms were maintained on metformin-sulfonylurea therapy. *P ≤ 0.001 compared with placebo treatment. Data are means ± SE.

  • Figure 3—
    • Download figure
    • Open in new tab
    • Download powerpoint
    Figure 3—

    Postprandial plasma glucose concentrations in the meal tolerance test subpopulation. A: Postprandial plasma glucose concentrations after a standardized meal at day 1. Subjects in all treatment arms received placebo. Postprandial plasma glucose geometric mean AUC(15–180 min) values were 2,033 mmol · min · l−1 in the 10-μg exenatide arm, 2,089 mmol · min · l−1 in the 5-μg exenatide arm, and 2,090 mmol · min · l−1 in the placebo arm. B: Postprandial plasma glucose concentrations after a standardized meal at week 30. Geometric mean AUC(15–180 min) values were 1,539 mmol · min · l−1 in the 10-μg exenatide arm (P = 0.0004 vs. placebo), 1,584 mmol · min · l−1 in the 5-μg exenatide arm (P = 0.0009 vs. placebo), and 2,087 mmol · min · l−1 in the placebo arm. Exenatide or placebo were administered at time zero. Evaluable population: 10 μg exenatide, n = 27; 5 μg exenatide, n = 27; placebo, n = 23. Subjects in the 10-μg exenatide b.i.d. arm received 5 μg exenatide b.i.d. during weeks 0–4. Subjects in all treatment arms were maintained on metformin-sulfonylurea therapy. Data are means ± SE.

  • Figure 4—
    • Download figure
    • Open in new tab
    • Download powerpoint
    Figure 4—

    Time-dependent incidence of subjects experiencing treatment-emergent nausea (ITT population).

Tables

  • Figures
  • Table 1—

    Most frequent adverse events with incidence ≥10% in any treatment arm (ITT)*

    Preferred termPlacebo5 μg exenatide10 μg exenatide
    n247245241
    Nausea51 (20.6)96 (39.2)117 (48.5)
    Hypoglycemia31 (12.6)47 (19.2)67 (27.8)
    Upper respiratory tract infection48 (19.4)28 (11.4)42 (17.4)
    Vomiting11 (4.5)36 (14.7)33 (13.7)
    Diarrhea16 (6.5)25 (10.2)42 (17.4)
    Feeling jittery17 (6.9)21 (8.6)28 (11.6)
    Headache12 (4.9)27 (11.0)18 (7.5)
    • Data are n (%).

    • *

      ↵* Treatment emergent.

  • Table 2—

    Change in A1C from baseline to week 30 and incidence of hypoglycemia stratified by sulfonylurea management group (ITT)

    Sulfonylurea management groupChange in A1C (%)
    Incidence of hypoglycemia (%)
    Placebo5 μg exenatide10 μg exenatidePlacebo5 μg exenatide10 μg exenatide
    MAX+0.2 ± 0.1−0.7 ± 0.1; P < 0.0001*−0.9 ± 0.1; P < 0.0001*15%22%35%
    MIN+0.3 ± 0.1−0.4 ± 0.1; P < 0.0001*−0.6 ± 0.1; P < 0.0001*10%16%21%
    • Data are means ± SE, unless otherwise noted.

    • *

      ↵* A1C change comparison for exenatide treatment versus placebo.

PreviousNext
Back to top
Diabetes Care: 28 (5)

In this Issue

May 2005, 28(5)
  • Table of Contents
  • About the Cover
  • Index by Author
Sign up to receive current issue alerts
View Selected Citations (0)
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word about Diabetes Care.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Effects of Exenatide (Exendin-4) on Glycemic Control Over 30 Weeks in Patients With Type 2 Diabetes Treated With Metformin and a Sulfonylurea
(Your Name) has forwarded a page to you from Diabetes Care
(Your Name) thought you would like to see this page from the Diabetes Care web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
Effects of Exenatide (Exendin-4) on Glycemic Control Over 30 Weeks in Patients With Type 2 Diabetes Treated With Metformin and a Sulfonylurea
David M. Kendall, Matthew C. Riddle, Julio Rosenstock, Dongliang Zhuang, Dennis D. Kim, Mark S. Fineman, Alain D. Baron
Diabetes Care May 2005, 28 (5) 1083-1091; DOI: 10.2337/diacare.28.5.1083

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Add to Selected Citations
Share

Effects of Exenatide (Exendin-4) on Glycemic Control Over 30 Weeks in Patients With Type 2 Diabetes Treated With Metformin and a Sulfonylurea
David M. Kendall, Matthew C. Riddle, Julio Rosenstock, Dongliang Zhuang, Dennis D. Kim, Mark S. Fineman, Alain D. Baron
Diabetes Care May 2005, 28 (5) 1083-1091; DOI: 10.2337/diacare.28.5.1083
del.icio.us logo Digg logo Reddit logo Twitter logo CiteULike logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • RESEARCH DESIGN AND METHODS
    • RESULTS
    • CONCLUSIONS
    • APPENDIX
    • Acknowledgments
    • Footnotes
    • References
  • Figures & Tables
  • Info & Metrics
  • PDF

Related Articles

Cited By...

More in this TOC Section

  • Autologous Umbilical Cord Blood Transfusion in Young Children With Type 1 Diabetes Fails to Preserve C-Peptide
  • Effects of MK-0941, a Novel Glucokinase Activator, on Glycemic Control in Insulin-Treated Patients With Type 2 Diabetes
  • Diabetes Antibody Standardization Program
Show more Emerging Treatments and Technologies

Similar Articles

Navigate

  • Current Issue
  • Standards of Care Guidelines
  • Online Ahead of Print
  • Archives
  • Submit
  • Subscribe
  • Email Alerts
  • RSS Feeds

More Information

  • About the Journal
  • Instructions for Authors
  • Journal Policies
  • Reprints and Permissions
  • Advertising
  • Privacy Policy: ADA Journals
  • Copyright Notice/Public Access Policy
  • Contact Us

Other ADA Resources

  • Diabetes
  • Clinical Diabetes
  • Diabetes Spectrum
  • Scientific Sessions Abstracts
  • Standards of Medical Care in Diabetes
  • BMJ Open - Diabetes Research & Care
  • Professional Books
  • Diabetes Forecast

 

  • DiabetesJournals.org
  • Diabetes Core Update
  • ADA's DiabetesPro
  • ADA Member Directory
  • Diabetes.org

© 2021 by the American Diabetes Association. Diabetes Care Print ISSN: 0149-5992, Online ISSN: 1935-5548.