Date

2015-10-29

Protocol

Protocol changed

Item Changed

Interventions

Previous Version

MK-0431A-170-02 Drugs used: 1. MK-0431A (sitagliptin/metformin fixed dose combination: 50/500, 50/850, and 50/1000 mg) 2. Metformin (500, 850, and 1000 mg) 3. Matching placebos Consenting participants will be randomized into two arms. There will be a 20-week double-blind treatment period. Arm 1 Regimen: one tablet of MK-0431A and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals. Arm 2 Regimen: one tablet MK-0431A-placebo and one tablet of metformin, administered twice daily prior to the morning and evening meals. Open-label insulin will be used as glycemic rescue therapy throughout the 20-week double-blind treatment period. Insulin will be sourced locally and administered subcutaneously based on American Diabetic Association guidelines for the indication and use of insulin MK-0431A-170-03 Open-label insulin initiated as glycemic rescue therapy during the base study and insulin glargine initiated in the extension study will be sourced locally, and administered subcutaneously based on instructions provided by the Investigator (based on accepted local, national or international guidelines for the indication and use of insulin). Patients in this study will remain on their randomized double-blind study medication assigned in the base study, and will initiate insulin glargine if their glycemic values meet protocol-specified thresholds

Next Version

MK-0431A-170-04 Drug: Metformin Drug: Sitagliptin + Metformin FDC Drug: Placebo to Metformin Drug: Placebo to Sitagliptin + Metformin FDC Biological: Insulin Biological: Insulin glargine MK-0431A (sitagliptin/metformin: 50/500, 50/850, and 50/1000 mg), metformin (500, 850, and 1000 mg), and their matching placebos will be supplied as oral tablets. During the 1-week single-blind placebo run-in period, patients will receive the following treatments: • one tablet of metformin (500 mg; 850 mg; or 1000 mg) and one tablet of MK-0431A placebo (matching the metformin dose), administered twice daily prior to the morning ane evening meals. During the 20-week double-blind treatment period, patients will receive one of the following treatments: • one tablet of MK-0431A and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals. one tablet MK-0431A-placebo and one tablet of metformin, administered twicedaily prior to the morning and evening meals. Open-label insulin (for background or rescue therapy) will be sourced locally and administered subcutaneously based on instructions provided by the Investigator (based on accepted local, national or international guidelines for the indication and use of insulin). Dose of background insulin should remain stable (of any type, variance in dose to be ?15% of total daily dose) for the duration of the trial MK-0431A-170-05 Open-label insulin (background or rescue therapy) taken during the base study and insulin glargine initiated in the extension study will be sourced locally, and administered subcutaneously based on instructions provided by the Investigator (based on accepted local, national or international guidelines for the indication and use of insulin). Patients in this study will remain on their randomized double-blind study medication assigned in the base study (if not on background insulin or rescued with insulin in the base study) that is deemed clinically inappropriate by the investigator if their glycemic values meet protocol-specified thresholds