Initial Oral Therapy for Patients With Type 2 Diabetes

STUDY

Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study Group: Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy.

SUMMARY

Design. Double-blind, randomized, controlled trial comparing initial therapy with rosiglitazone, metformin, or glyburide for patients with type 2 diabetes.

Subjects. A total of 4,360 patients aged 30-75 years with fasting plasma glucose levels from 126 to 180 mg/dl when treated with lifestyle change recommendations alone. Patients with clinically significant liver disease, renal impairment, unstable or severe angina, congestive heart failure, or uncontrolled hypertension were excluded.

Methods. Patients were recruited from 488 centers in North America and Europe between April 2000 and June 2002. Participants received one of three initial regimens: 4 mg of rosiglitazone daily, 500 mg of metformin daily, or 2.5 mg of glyburide daily. Medication dosages were titrated upward at each visit if fasting plasma glucose was > 140 mg/dl. Titrations were based on study protocols with a …