Document Classification

Section Type: METHODS

Text: Patients assigned to active therapy in the 54-week base study remained on those treatments in the extension study : sitagliptin 50 mg b. i. d. + metformin 1000 mg b. i. d. (higher dose combination), sitagliptin 50 mg b. i. d. + metformin 500 mg b. i. d. (lower dose combination), metformin 1000 mg b. i. d. (higher dose), metformin 500 mg b. i. d. (lower dose) and sitagliptin 100 mg q. d. Patients randomized to receive the sequence of placebo/metformin were switched, in a blinded manner, from placebo to metformin monotherapy uptitrated to 1000 mg b. i. d. beginning at week 24 and remained on higher dose metformin through the extension.