A Diabetes Outcome Progression Trial (ADOPT)
| Autor: | William H. Herman, Bernard Zinman, John M. Lachin, Giancarlo Viberti, Martin I. Freed, Daniel Levy, Douglas A. Greene, Steven E. Kahn, Rury R. Holman, Nigel P. Jones, Heise Ma, Steven M. Haffner, Rhona A. Berry |
|---|---|
| Rok vydání: | 2002 |
| Předmět: |
Advanced and Specialized Nursing
medicine.medical_specialty business.industry Endocrinology Diabetes and Metabolism Type 2 diabetes medicine.disease law.invention Metformin Glibenclamide Endocrinology Randomized controlled trial Tolerability law Diabetes mellitus Internal medicine Internal Medicine medicine business Rosiglitazone Macrovascular disease medicine.drug |
| Zdroj: | Diabetes Care. 25:1737-1743 |
| ISSN: | 1935-5548 0149-5992 |
| Popis: | 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 ( 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 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|