Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 +/- 10 years, BMI 33.6 +/- 5.7 kg/m(2), A1C 8.5 +/- 1.0%; means +/- SD) randomized to 5 microg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks. Thereafter, arm A remained at 5 microg b.i.d. and arm B escalated to 10 microg b.i.d. Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea. RESULTS: Week 30 A1C changes from baseline (+/-SE) were -0.8 +/- 0.1% (10 microg), -0.6 +/- 0.1% (5 microg), and +0.2 +/- 0.1% (placebo; adjusted P < 0.0001 vs. placebo), yielding placebo-adjusted reductions of -1.0% (10 microg) and -0.8% (5 microg). In the evaluable population, exenatide-treated subjects were more likely to achieve A1C < or =7% than placebo-treated subjects (34% [10 microg], 27% [5 microg], and 9% [placebo]; P < 0.0001). Both exenatide arms demonstrated significant weight loss (-1.6 +/- 0.2 kg from baseline each exenatide arm, -0.9 +/- 0.2 kg placebo; P < or = 0.01 vs. placebo). Mild or moderate nausea was the most frequent adverse event. The incidence of mild/moderate hypoglycemia was 28% (10 microg), 19% (5 microg), and 13% (placebo) and appeared lower with MIN than with MAX sulfonylurea treatment. CONCLUSIONS:
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Authors | David M Kendall, Matthew C Riddle, Julio Rosenstock, Dongliang Zhuang, Dennis D Kim, Mark S Fineman, Alain D Baron |
Journal | Diabetes care
(Diabetes Care)
Vol. 28
Issue 5
Pg. 1083-91
(May 2005)
ISSN: 0149-5992 [Print] United States |
PMID | 15855571
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Peptides
- Sulfonylurea Compounds
- Venoms
- Metformin
- Exenatide
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Topics |
- Adult
- Aged
- Blood Glucose
(drug effects)
- Body Weight
- Diabetes Mellitus, Type 2
(drug therapy)
- Drug Therapy, Combination
- Exenatide
- Female
- Glycated Hemoglobin
(metabolism)
- Humans
- Hyperglycemia
(drug therapy)
- Hypoglycemic Agents
(administration & dosage, adverse effects)
- Male
- Metformin
(administration & dosage, adverse effects)
- Middle Aged
- Peptides
(administration & dosage, adverse effects)
- Sulfonylurea Compounds
(administration & dosage, adverse effects)
- Venoms
(administration & dosage, adverse effects)
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