Effects of exenatide (Exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes

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

doi:10.2337/diacare.27.11.2628

Cited by 1,346Diabetes Treatment and ManagementDiabetes Management and ResearchPharmacology and Obesity Treatment

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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Abstract

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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In a triple-blind placebo-controlled 30-week study of T2DM patients with BMI 33±6 kg/m2, weight loss in EX treatment group was significantly higher than control; primary adverse reaction was nausea, suggesting nausea may be primary mechanism of weight loss.
“In a triple-blind, placebo-controlled 30-week clinical study involving patients with T2DM with a BMI of 33 ± 6 kg/m2, it was found that the weight loss in the EX treatment group was significantly higher than that in the control group. The primary adverse reaction to EX is nausea, suggesting that nausea may be the primary mechanism of weight loss (52).”
From GLP−1 receptor agonists for the treatment of obesity: Role as a promising approach (2023) · cites this paper as [52]
Exendin-4 appears to lower A1C levels by 0.5-1 percentage points, mainly by lowering postprandial blood glucose levels.
“exendin-4 appears to lower A1C levels by 0.5–1 percentage points, mainly by lowering postprandial blood glucose levels (78–81).”
From Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy (2009) · cites this paper as [80]
Exenatide is not associated with hypoglycemia but causes a relatively high frequency of gastrointestinal disturbances, with 30-45% of treated patients experiencing one or more episodes of nausea, vomiting, or diarrhea.
“It is not associated with hypoglycemia but causes a relatively high frequency of gastrointestinal disturbances, with 30–45% of treated patients experiencing one or more episodes of nausea, vomiting, or diarrhea (78–81).”
From Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy (2009) · cites this paper as [80]
Multiple trials of exenatide have demonstrated statistically significant reductions in weight and BP over a prolonged period, but the changes in BP were small.
“Multiple trials assessing the efficacy of exenatide have demonstrated statistically significant reductions in weight and BP [202][203][204][205] over a prolonged period but the changes in BP were small.206,207”
From Obesity‐Related Hypertension: Pathogenesis, Cardiovascular Risk, and Treatment: A Position Paper of The Obesity Society and the American Society of Hypertension (2013) · cites this paper as [204]

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A 2004 Effect of exenatide (exendin-4) on glycemic control and safety over 30 weeks in sulfonylureatreated patients with type 2 diabetes. Diabetes 53(Suppl 2):A82 (Abstract 352-OR) Endocrinology is published monthly by The Endocrine Society (http://www.en
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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 › 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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