A diabetes outcome progression trial (ADOPT)

被引:179
作者
Viberti, G
Kahn, SE
Greene, DA
Herman, WH
Zinman, B
Holman, RR
Haffner, SM
Levy, D
Lachin, JM
Berry, RA
Heise, MA
Jones, NP
Freed, MI
机构
[1] Kings Coll London, Guys Kings & St Thomas Sch Med, London WC2R 2LS, England
[2] Univ Washington, Dept Med, Div Metab Endocrinol & Nutr, Seattle, WA 98195 USA
[3] Puget Sound Hlth Care Syst, Dept Vet Affairs, Seattle, WA USA
[4] Univ Michigan, Sch Med, Dept Internal Med, Ann Arbor, MI USA
[5] Mt Sinai Hosp, Samuel Lunenfeld Res Inst, Toronto, ON M5G 1X5, Canada
[6] Oxford Ctr Diabet Endocrinol & Metab, Diabet Trials Unit, Oxford, England
[7] Univ Texas, Hlth Sci Ctr, San Antonio, TX USA
[8] Framingham Heart Dis Epidemiol Study, Framingham, MA USA
[9] George Washington Univ, Ctr Biostat, Rockville, MD USA
[10] GlaxoSmithKline, Philadelphia, PA USA
关键词
D O I
10.2337/diacare.25.10.1737
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVE - Therapies with metformin, sulfonylureas, or insulin improve glycemic control in the short term but do not prevent progressive islet beta-cell failure or long-term deterioration in glycemia. Our goal was to evaluate, in patients recently diagnosed with type 2 diabetes (<3 years), the long-term efficacy of monotherapy with rosiglitazone on glycemic control and on the progression of pathophysiological abnormalities associated with type 2 diabetes as compared with metformin or glyburide monotherapy. RESEARCH DESIGN AND METHODS - A Diabetes Outcome Progression Trial (ADOPT) is a randomized, double-blind, parallel-group study consisting of a screening visit, a 4-week placebo run-in, a 4-year treatment period, and an observational follow-up of similar to3,600 drug-naive patients with type 2 diabetes diagnosed within the previous 3 years. After run-in, patients will be randomized to rosiglitazone, glyburide, or metformin titrated to the maximum effective daily doses (8 mg rosiglitazone, 15 mg glyburide, or 2 g metformin). The primary outcome is time to monotherapy failure, defined as the time following titration to the maximal effective or tolerated dose when fasting plasma glucose exceeds 180 mg/dl (10 mmol/l). Secondary outcomes include treasures of islet beta-cell function, insulin sensitivity, dyslipldemia, changes in urinary albumin excretion, plasminogen activator inhibitor-1 antigen, fibrinogen, and C-reactive protein. Safety and tolerability will also be evaluated. Patient-reported Outcomes and resource utilization data will be collected and analyzed. CONCLUSIONS - ADOPT will provide data on the effect of mechanistically differing treatment options on metabolic control, beta-cell and markers of macrovascular disfunction, ease risk in type 2 diabetes.
引用
收藏
页码:1737 / 1743
页数:7
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