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From the Samuel Lunenfeld Research Institute, Mount Sinai Hospital, and University of Toronto, Toronto, Ontario, Canada; The Cleveland Clinic, Cleveland, Ohio; Hospital Universitario Nuestra Señora de Valme, Seville, Spain; Eli Lilly and Company, Indianapolis, Indiana; Amylin Pharmaceuticals, San Diego, California; and Eli Lilly and Company, Hamburg, Germany.
Acknowledgments: The authors thank David Kendall, Michael Mihm, Jill Beach, Margaret Perry, and William Gurdian for their contributions to the conduct of the study and the development of the manuscript.
Grant Support: By Eli Lilly and Company, Indianapolis, Indiana, and Amylin Pharmaceuticals, San Diego, California.
Potential Financial Conflicts of Interest: Employment: D.R. Milton (Eli Lilly and Company), J.M. Giaconia (Eli Lilly and Company), D.D. Kim (Amylin Pharmaceuticals Inc.), M.E. Trautmann (Eli Lilly and Company), R.G. Brodows (Eli Lilly and Company); Consultancies: B. Zinman (Amylin Pharmaceuticals Inc., Eli Lilly and Company), B.J. Hoogwerf (Amylin Pharmaceuticals Inc.); Honoraria: B. Zinman (Eli Lilly and Company), B.J. Hoogwerf (Amylin Pharmaceuticals Inc., Eli Lilly and Company), S. Durán García (Eli Lilly and Company); Stock ownership or options (other than mutual funds): D.R. Milton (Eli Lilly and Company), J.M. Giaconia (Eli Lilly and Company), D.D. Kim (Amylin Pharmaceuticals Inc.), M.E. Trautmann (Eli Lilly and Company), R.G. Brodows (Eli Lilly and Company); Grants received: B. Zinman (Eli Lilly and Company); Patents pending: M.E. Trautmann (Eli Lilly and Company).
Requests for Single Reprints: Bernard Zinman, MD, Mount Sinai Hospital, 60 Murray Street, Suite L 5-024, Mail Box 17, Toronto, M5T 3L9 Ontario, Canada; e-mail, email@example.com.
Current Author Addresses: Dr. Zinman: Mount Sinai Hospital, 60 Murray Street, Suite L 5-024, Mail Box 17, Toronto, M5T 3L9 Ontario, Canada.
Dr. Hoogwerf: Desk A-53, Endocrinology, Diabetes and Metabolism, The Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195.
Dr. Durán García: Department of Endocrinology, Valme Hospital, 41018 Seville, Spain.
Ms. Milton, Mr. Giaconia, and Dr. Brodows: Eli Lilly and Company, Lilly Corporate Center, DC 6015, Indianapolis, IN 46285.
Dr. Kim: Amylin Pharmaceuticals, 9360 Towne Centre Drive, San Diego, CA 92121.
Dr. Trautmann: Lilly Research, Essener Bogen 7, Hamburg, D-22419, Germany.
Author Contributions: Conception and design: B. Zinman, D.D. Kim, M.E. Trautmann, R.G. Brodows.
Analysis and interpretation of the data: B. Zinman, B.J. Hoogwerf, S. Durán García, D.R. Milton, J.M. Giaconia, D.D. Kim, M.E. Trautmann, R.G. Brodows.
Drafting of the article: B. Zinman, B.J. Hoogwerf, S. Durán García, D.R. Milton, J.M. Giaconia, D.D. Kim, M.E. Trautmann, R.G. Brodows.
Critical revision of the article for important intellectual content: B. Zinman, B.J. Hoogwerf, S. Durán García, D.R. Milton, J.M. Giaconia, D.D. Kim, R.G. Brodows.
Final approval of the article: B. Zinman, B.J. Hoogwerf, S. Durán García, D.R. Milton, J.M. Giaconia, D.D. Kim, M.E. Trautmann, R.G. Brodows.
Provision of study materials or patients: B. Zinman, S. Durán García.
Statistical expertise: D.R. Milton.
Administrative, technical, or logistic support: B. Zinman, J.M. Giaconia, R.G. Brodows.
Our study demonstrates that exenatide in combination with a TZD improves glycemic control in patients with type 2 diabetes that is suboptimally controlled with a TZD, either alone or in combination with metformin. Exenatide therapy, in combination with TZD therapy, improved hemoglobin A1c levels, fasting blood glucose levels, and postprandial glucose excursions and reduced body weight over 16 weeks. Exenatide treatment also improved clinical measures of β-cell function. The most commonly reported adverse event associated with exenatide treatment was mild to moderate nausea that diminished with time and continued use of exenatide. Nonetheless, some individuals did not tolerate these side effects well (9% and 5% of patients discontinued the study because of nausea and vomiting, respectively). No clinically significant episodes of hypoglycemia were reported.
Effects of exenatide (top) and placebo (bottom) on 7-point, self-monitored blood glucose profiles at baseline (open symbols) and week 16 (closed symbols) are shown. All results (reported as means [±SE]) were obtained from the mixed-effects model analyses of the intention-to-treat sample. Numbers of exenatide patients at each point were 115 at prebreakfast, 111 at postbreakfast, 113 at prelunch, 111 at postlunch, 114 at predinner, 109 at postdinner, and 99 at bedtime. Corresponding numbers of patients in the placebo group were 110, 109, 108, 108, 109, 109, and 94, respectively. To convert glucose values from mmol/L to mg/dL, divide by 0.0555. *P < 0.001.
All results were obtained from the mixed-effects model of 121 patients who received exenatide (circles) and 110 patients who received placebo (triangles) in the intention-to-treat analysis. Mean (±SE) body weight changes at week 16 were −1.75 kg ± 0.25 kg for exenatide recipients and −0.24 kg ± 0.26 kg for placebo recipients. *P < 0.01. †P < 0.001.
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Exenatide Therapy for Type 2 Diabetes
The summary below is from the full report titled “The Effect of Adding Exenatide to a Thiazolidinedione in Suboptimally Controlled Type 2 Diabetes. A Randomized Trial.” It is in the 3 April 2007 issue of Annals of Internal Medicine (volume 146, pages 477-485). The authors are B. Zinman, B.J. Hoogwerf, S. Durán García, D.R. Milton, J.M. Giaconia, D.D. Kim, M.E. Trautmann, and R.G. Brodows.
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