A randomized clinical trial evaluating the safety and efficacy of sitagliptin added to the combination of sulfonylurea and metformin in patients with type 2 diabetes mellitus and inadequate glycemic control

• Published in: Journal of diabetes 2016-09, Vol.8 (5), p.701-711
• Main Authors: Moses, Robert G., Round, Elizabeth, Shentu, Yue, Golm, Gregory T., O'neill, Edward A., Gantz, Ira, Engel, Samuel S., Kaufman, Keith D., Goldstein, Barry J.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Blood Glucose - metabolism; Clinical trials; combination therapy; Diabetes; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; dipeptidyl peptidase-4; Double-Blind Method; Drug Therapy, Combination; Female; Glucose; Glycated Hemoglobin A - metabolism; Humans; Hypoglycemia; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; incretins; Male; Metformin - adverse effects; Metformin - therapeutic use; Middle Aged; Single-Blind Method; Sitagliptin Phosphate - adverse effects; Sitagliptin Phosphate - therapeutic use; Sulfonylurea Compounds - adverse effects; Sulfonylurea Compounds - therapeutic use; Time Factors; Treatment Outcome; 二肽基肽酶; 联合治疗; 肠促胰素
• ISSN: 1753-0393; 1753-0407
• DOI: 10.1111/1753-0407.12351

Background Type 2 diabetes mellitus (T2DM) treatment generally requires multiple antihyperglycemic agents. When diet, exercise, and treatment with sulfonylurea and metformin do not achieve glycemic goals, several options are available. The present study evaluated the efficacy and tolerability of sitagliptin 100 mg/day added to therapy with sulfonylurea and metformin. Methods Patients with HbA1c ≥7.5% and ≤10.5% while on a sulfonylurea and metformin were randomized 1: 1 to sitagliptin 100 mg/day or placebo for 24 weeks. At Week 24, patients in the placebo group switched to pioglitazone 30 mg/day and both groups continued treatment for another 30 weeks. Results Of 427 patients randomized, 339 (79.4%) completed the study. At Week 24, significantly greater (P