Abstract | BACKGROUND: OBJECTIVE: DESIGN: 26-week multicenter, open-label, randomized, controlled trial. SETTING: 82 outpatient study centers in 13 countries. PATIENTS: INTERVENTION: MEASUREMENTS: 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:
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Authors | Robert J Heine, Luc F Van Gaal, Don Johns, Michael J Mihm, Mario H Widel, Robert G Brodows, GWAA Study Group |
Journal | Annals of internal medicine
(Ann Intern Med)
Vol. 143
Issue 8
Pg. 559-69
(Oct 18 2005)
ISSN: 1539-3704 [Electronic] United States |
PMID | 16230722
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Insulin
- Insulin, Long-Acting
- Peptides
- Venoms
- Insulin Glargine
- Exenatide
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Topics |
- Adult
- Aged
- Blood Glucose
(metabolism)
- Blood Glucose Self-Monitoring
- Body Weight
(drug effects)
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Exenatide
- Female
- Glycated Hemoglobin
(metabolism)
- Humans
- Hypoglycemia
(chemically induced)
- Hypoglycemic Agents
(adverse effects, therapeutic use)
- Insulin
(adverse effects, analogs & derivatives, therapeutic use)
- Insulin Glargine
- Insulin, Long-Acting
- Male
- Middle Aged
- Nausea
(chemically induced)
- Peptides
(adverse effects, therapeutic use)
- Venoms
(adverse effects, therapeutic use)
- Vomiting
(chemically induced)
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