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Cited by 796Diabetes Treatment and ManagementDiabetes Management and ResearchDiabetes, Cardiovascular Risks, and Lipoproteins

The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.

Exenatide versus Insulin Glargine in Patients with Suboptimally Controlled Type 2 Diabetes: A Randomized Trial

Heine, Robert J., Van Gaal, Luc F., Johns, Don, Mihm, Michael J., Widel, Mario H., Brodows, Robert G., for the GWAA Study Group*·2005·Annals of Internal Medicine
DOI 10.7326/0003-4819-143-8-200510180-00006
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Abstract

BACKGROUND: Physicians may use either insulin or exenatide injections for patients with type 2 diabetes mellitus who have poor glycemic control despite taking oral blood glucose-lowering drugs. OBJECTIVE: To compare effects of exenatide and insulin glargine on glycemic control in patients with type 2 diabetes mellitus that is suboptimally controlled with metformin and a sulfonylurea. DESIGN: 26-week multicenter, open-label, randomized, controlled trial. SETTING: 82 outpatient study centers in 13 countries. PATIENTS: 551 patients with type 2 diabetes and inadequate glycemic control (defined as hemoglobin A1c level ranging from 7.0% to 10.0%) despite combination metformin and sulfonylurea therapy. INTERVENTION: Exenatide, 10 microg twice daily, or insulin glargine, 1 daily dose titrated to maintain fasting blood glucose levels of less than 5.6 mmol/L (<100 mg/dL). MEASUREMENTS: Hemoglobin A1c level, fasting plasma glucose level, body weight, 7-point self-monitored blood glucose, standardized test-meal challenge, safety, and tolerability. RESULTS: Baseline mean hemoglobin A1c level was 8.2% for patients receiving exenatide and 8.3% for those receiving insulin glargine. At week 26, both exenatide and insulin glargine reduced hemoglobin A1c levels by 1.11% (difference, 0.017 percentage point [95% CI, -0.123 to 0.157 percentage point]). Exenatide reduced postprandial glucose excursions more than insulin glargine, while insulin glargine reduced fasting glucose concentrations more than exenatide. Body weight decreased 2.3 kg with exenatide and increased 1.8 kg with insulin glargine (difference, -4.1 kg [CI, -4.6 to -3.5 kg]). Rates of symptomatic hypoglycemia were similar, but nocturnal hypoglycemia occurred less frequently with exenatide (0.9 event/patient-year versus 2.4 events/patient-year; difference, -1.6 events/patient-year [CI, -2.3 to -0.9 event/patient year]). Gastrointestinal symptoms were more common in the exenatide group than in the insulin glargine group, including nausea (57.1% vs. 8.6%), vomiting (17.4% vs. 3.7%) and diarrhea (8.5% vs. 3.0%). LIMITATIONS: The trial was open-label and did not assess clinical complications related to diabetes. Of the 551 participants, 19.4% of those receiving exenatide and 9.7% of those receiving insulin glargine withdrew from the study. Only 21.6% of the insulin glargine group and 8.6% of the exenatide group achieved the target level for fasting plasma glucose of less than 5.6 mmol/L (<100 mg/dL). CONCLUSIONS: Exenatide and insulin glargine achieved similar improvements in overall glycemic control in patients with type 2 diabetes that was suboptimally controlled with oral combination therapy. Exenatide was associated with weight reduction and had a higher incidence of gastrointestinal adverse effects than insulin glargine.

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  1. Fehse FC, 2004, Diabetes, 53, A82

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Metadata

Authors
Heine, R. J., Van Gaal, L. F., Johns, D., Mihm, M. J., Widel, M. H., Brodows, R. G., & for the GWAA Study Group*
Affiliations
  • Eli Lilly (United States) (US)
  • From VU University Medical Center, Amsterdam, the Netherlands; University Hospital of Antwerp, Antwerp, Belgium; and Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.
Venue
Annals of Internal Medicine
Publisher
American College of Physicians
Published
2005-10-18
Volume
143
Issue
8
Pages
559-569
ISSN
  • 0003-4819 (ISSN-L)
  • 1539-3704
DOI
10.7326/0003-4819-143-8-200510180-00006
OpenAlex
W2028272916
Cited by
795
References
33
Citations by year
2026: 2 · 2025: 7 · 2024: 4 · 2023: 1 · 2022: 7 · 2021: 10 · 2020: 7 · 2019: 11 · 2018: 14 · 2017: 30 · 2016: 28 · 2015: 30 · 2014: 32 · 2013: 41 · 2012: 61
FWCI
51.12
Type
journal article
Language
en
Open access
closed
Licence
www.acpjournals.org/journal/aim/text-and-data-mining (tdm)
Locations
  • Annals of Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
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 › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
insulin glargine, type 2 diabetes, glycemic control, metformin, sulfonylureas, GLP-1 receptor agonists, HbA1c, fasting blood glucose, postprandial blood glucose, body weight, hypoglycemia, gastrointestinal adverse effects, drug safety and tolerability, combination therapy, self-monitoring of blood glucose
MeSH terms
Insulin Glargine, Exenatide, Adult, Aged, Blood Glucose, Body Weight, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Middle Aged, Nausea, Peptides, Venoms, Vomiting, Blood Glucose Self-Monitoring, Insulin, Long-Acting

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