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- Title
A Diabetes Outcome Progression Trial (ADOPT).
- Authors
Viberti, Giancarlo; Kahn, Steven E.; Greene, Douglas A.; Herman, William H.; Zinman, Bernard; Holman, Rury R.; Haffner, Steven M.; Levy, Daniel; Lachin, John M.; Berry, Rhona A.; Heise, Mark A.; Jones, Nigel P.; Freed, Martin I.
- Abstract
OBJECTIVE -- Therapies with metformin, sulfonylureas, or insulin improve glycemic control in the short term but do not prevent progressive islet β-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 ∼3,600 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 measures of islet β-cell function, insulin sensitivity, dyslipidemia, 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, β-cell function, and markers of macrovascular disease risk in type 2 diabetes.
- Subjects
TYPE 2 diabetes treatment; DRUG efficacy
- Publication
Diabetes Care, 2002, Vol 25, Issue 10, p1737
- ISSN
0149-5992
- Publication type
Article
- DOI
10.2337/diacare.25.10.1737