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A Diabetes Outcome Progression Trial (ADOPT)

An international multicenter study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetes

¹ Guy’s, King’s, and St. Thomas’ School of Medicine, King’s College, London, U.K.
² Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, University of Washington and Department of Veterans Affairs Puget Sound Health Care System, Seattle, Washington
³ Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan
⁴ Samuel Lunenfeld Research Institute, Mt. Sinai Hospital, Toronto, Canada
⁵ Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, U.K.
⁶ University of Texas Health Science Center at San Antonio, San Antonio, Texas
⁷ Framingham Heart Study, Framingham, Massachusetts
⁸ Biostatistics Center, George Washington University, Rockville, Maryland
⁹ GlaxoSmithKline Pharmaceuticals, Collegeville, Philadelphia, Pennsylvania

OBJECTIVE—Therapies with metformin, sulfonylureas, or insulin improve glycemic control in the short term but do not prevent progressive islet ß-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-naïve 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 ß-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, ß-cell function, and markers of macrovascular disease risk in type 2 diabetes.

Abbreviations: ACR, albumin-to-creatinine ratio • ADA, American Diabetes Association • ADOPT, A Diabetes Outcome Progression Trial • AE, adverse event • CHD, coronary heart disease • CRP, C-reactive protein • DSC, Diabetes Symptoms Checklist • DTSQ, Diabetes Treatment Satisfaction Questionnaire • FPG, fasting plasma glucose • HCG, human chorionic gonadotrophin • HOMA, homeostasis model assessment • HPI, intact human proinsulin • hsCRP, highly sensitive CRP • MRFIT, Multiple Risk Factor Intervention Trial • OGTT, oral glucose tolerance test • PAI-1, plasminogen activator inhibitor-1 • PI/IRI, proinsulin-to-immunoreactive insulin ratio • SF-36, Medical Outcomes Study 36-Item Short-Form Health Survey • UKPDS, U.K. Prospective Diabetes Study

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