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

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Buse, John B., Henry, Robert R., Han, Jenny, Kim, Dennis D., Fineman, Mark S., Baron, Alain D., for the Exenatide-113 Clinical Study Group·2004·Diabetes Care

DOI 10.2337/diacare.27.11.2628

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OBJECTIVE—This study evaluated the ability of the incretin mimetic exenatide (exendin-4) to improve glycemic control in patients with type 2 diabetes failing maximally effective doses of a sulfonylurea as monotherapy. RESEARCH DESIGN AND METHODS—This was a triple-blind, placebo-controlled, 30-week study conducted at 101 sites in the U.S. After a 4-week, single-blind, placebo lead-in period, 377 subjects were randomized (60% men, age 55 ± 11 years, BMI 33 ± 6 kg/m2, HbA1c 8.6 ± 1.2% [±SD]) and began 4 weeks at 5 μg subcutaneous exenatide twice daily (before breakfast and dinner; arms A and B) or placebo. Subsequently, subjects in arm B were escalated to 10 μg b.i.d. exenatide. All subjects continued sulfonylurea therapy. RESULTS—At week 30, HbA1c changes from baseline were −0.86 ± 0.11, −0.46 ± 0.12, and 0.12 ± 0.09% (±SE) in the 10-μg, 5-μg, and placebo arms, respectively (adjusted P < 0.001). Of evaluable subjects with baseline HbA1c > 7% (n = 237), 41% (10 μg), 33% (5 μg), and 9% (placebo) achieved HbA1c ≤ 7% (P < 0.001). Fasting plasma glucose concentrations decreased in the 10-μg arm compared with placebo (P < 0.05). Subjects in the exenatide arms had dose-dependent progressive weight loss, with an end-of-study loss in the 10-μg exenatide arm of −1.6 ± 0.3 kg from baseline (P < 0.05 vs. placebo). The most frequent adverse events were generally mild or moderate and gastrointestinal in nature. No severe hypoglycemia was observed. CONCLUSIONS—Exenatide significantly reduced HbA1c in patients with type 2 diabetes failing maximally effective doses of a sulfonylurea. Exenatide was generally well tolerated and was associated with weight loss.

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Authors: Buse, J. B., Henry, R. R., Han, J., Kim, D. D., Fineman, M. S., Baron, A. D., & for the Exenatide-113 Clinical Study Group
Affiliations: University of North Carolina at Chapel Hill (US)
University of California San Diego (US)
Amylin Pharmaceuticals, San Diego, California
ORCID: Buse, John B.
Henry, Robert R.
Kim, Dennis D.
Fineman, Mark S.
Venue: Diabetes Care
Publisher: American Diabetes Association
Published: 2004-11-01
Volume: 27
Issue: 11
Pages: 2628-2635
ISSN: 0149-5992 (ISSN-L)
1935-5548
DOI: 10.2337/diacare.27.11.2628
OpenAlex: W1986085856
Cited by: 1,346
References: 38
Citations by year: 2026: 18 · 2025: 22 · 2024: 17 · 2023: 7 · 2022: 13 · 2021: 24 · 2020: 20 · 2019: 16 · 2018: 19 · 2017: 30 · 2016: 53 · 2015: 46 · 2014: 76 · 2013: 79 · 2012: 120
FWCI: 56.01
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Diabetes Care (publishedVersion)
PubMed (publishedVersion)
Funders: Eli Lilly and Company
Amylin Pharmaceuticals
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
Keywords: exenatide, exendin-4, type 2 diabetes, sulfonylureas, glycemic control, HbA1c, incretin mimetics, dose escalation, weight loss, fasting blood glucose, gastrointestinal adverse effects, hypoglycemia, combination therapy, long-term efficacy and safety
MeSH terms: Exenatide, Adult, Aged, Blood Glucose, Body Weight, Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug, Fasting, Female, Glycated Hemoglobin, Humans, Insulin, Male, Middle Aged, Peptides, Proinsulin, Sulfonylurea Compounds, Venoms, Weight Loss, Treatment Failure, Retreatment

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

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