Abstract | BACKGROUND/PURPOSE:
Exenatide has been predominantly studied in non-Asian populations. The purpose of this study was to investigate the safety and efficacy of twice-daily (BID) exenatide versus placebo in a subpopulation of Taiwanese patients from a larger study on Asian patients. METHODS: Patients unable to achieve glycemic control with metformin alone or metformin in combination with sulfonylurea were randomly assigned to self-administer either 5 μg exenatide or placebo BID for 4 weeks, then 10 μg exenatide or placebo BID for an additional 12 weeks, in addition to their regular oral therapy. RESULTS: Fifty patients from Taiwan were enrolled in this study (54.0% male; age: 50.9 ± 9.4 years; weight: 71.0 ± 11.6 kg; 8.1 ± 1.0% hemoglobin A1c (HbA1c)). The exenatide-treated patients demonstrated a statistically significant greater reduction in HbA1c from baseline to the endpoint (least-squares [LS] mean [95% confidence interval (CI)]: -0.8% [-1.4 - -0.2]; p = 0.009) compared with patients who received placebo (LS mean [95% CI]: -0.1% [-0.7-0.4]) with an LS mean [95% CI] between-group difference of -0.7% (-1.3 - -0.1) (p = 0.025). A statistically significant higher number of exenatide-treated patients achieved HbA1c targets of ≤ 7% (p = 0.020) and ≤ 6.5% (p = 0.021) by the endpoint compared with patients who received placebo. Exenatide-treated patients experienced a statistically significant reduction in weight from baseline to endpoint ( exenatide-placebo adjusted mean difference [95% CI]: -1.6 kg [-2.7 - -0.6]; p = 0.004) compared with the placebo group. The symptomatic hypoglycemia rate (mean patient/year ± standard deviation) was higher in exenatide-treated patients (4.86 mean patient/year ± 7.36) than placebo-treated patients (0.27 mean patient/year ± 1.32). Thirteen (50.0%) exenatide-treated patients and nine (37.5%) placebo-treated patients reported one or more treatment-emergent adverse events; nausea was the most frequently reported side effect ( exenatide, 4 [15.4%]; placebo, 0 [0.0%]). CONCLUSION:
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Authors | Chieh-Hsiang Lu, Ta-Jen Wu, Kuang-Chung Shih, Ewan Ni, Victoria Reed, Maria Yu, Wayne H-H Sheu, Lee-Ming Chuang |
Journal | Journal of the Formosan Medical Association = Taiwan yi zhi
(J Formos Med Assoc)
Vol. 112
Issue 3
Pg. 144-50
(Mar 2013)
ISSN: 0929-6646 [Print] Singapore |
PMID | 23473527
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2012. Published by Elsevier B.V. |
Chemical References |
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Peptides
- Venoms
- hemoglobin A1c protein, human
- Exenatide
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Topics |
- Adult
- Aged
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Double-Blind Method
- Drug Administration Schedule
- Exenatide
- Female
- Glycated Hemoglobin
(analysis)
- Humans
- Hypoglycemic Agents
(administration & dosage)
- Male
- Middle Aged
- Peptides
(administration & dosage, adverse effects)
- Venoms
(administration & dosage, adverse effects)
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