Abstract | BACKGROUND AND OBJECTIVE: METHODS: Subjects on pre-existing insulin glargine (with or without oral antidiabetes agents) were randomized to placebo (n = 123) or exenatide BID (n = 138; 5 µg for 4 weeks, then 10 µg ongoing). Insulin glargine was titrated in both arms per the Treat-to-Target algorithm. Tertiles (T1, T2, T3) were based on change in insulin dose from baseline to endpoint. Change in HbA(1c), hypoglycemia risk, and weight gain were assessed per insulin dose tertile. RESULTS: The population comprised adult patients (mean age = 59 y) with type 2 diabetes and an HbA(1c) level between 7.0% and 10.5% (mean HbA(1c) = 8.4%). Insulin titration ranged from modest reductions in T1 to substantial increases in T3. Greater improvements in HbA1c were demonstrated with exenatide BID versus placebo in all tertiles (statistically significant in T2 and T3). With exenatide BID, more subjects achieved HbA(1c) <7.0% vs. placebo: T1, 44% vs. 29% (P = not significant); T2, 65% vs. 26%; T3, 54% vs. 29% (P < 0.05 for T2 and T3). Incidence of hypoglycemia was numerically lower with exenatide BID in all tertiles. Adjunctive exenatide BID was associated with statistically significantly greater weight loss (T1, T2) or mitigation of weight gain (T3) compared with placebo. Rates of nausea (42% vs. 8%), diarrhea (18% vs. 7%), and vomiting (18% vs. 4%) were higher with exenatide BID than with placebo and did not vary by tertile. CONCLUSIONS:
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Authors | John B Buse, Jenny Han, Stephan Miller, Leigh MacConell, Richard Pencek, Matthew Wintle |
Journal | Current medical research and opinion
(Curr Med Res Opin)
Vol. 30
Issue 7
Pg. 1209-18
(Jul 2014)
ISSN: 1473-4877 [Electronic] England |
PMID | 24621255
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Biomarkers
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Insulin, Long-Acting
- Peptides
- Venoms
- hemoglobin A1c protein, human
- Insulin Glargine
- Exenatide
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Biomarkers
(blood)
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Drug Therapy, Combination
- Exenatide
- Female
- Glycated Hemoglobin
(metabolism)
- Humans
- Hypoglycemic Agents
(therapeutic use)
- Insulin Glargine
- Insulin, Long-Acting
(therapeutic use)
- Male
- Middle Aged
- Peptides
(therapeutic use)
- Titrimetry
- Treatment Outcome
- Venoms
(therapeutic use)
- Weight Loss
- Young Adult
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