Open AccessEfficacy and safety of sitagliptin added to ongoing metformin and rosiglitazone combination therapy in a randomized placebo‐controlled 54‐week trial in patients with type 2 diabetes (一项为期54周的对持续使用二甲双胍与罗格列酮联合治疗的2型糖尿病患者加用西格列汀治疗的有效性与安全性的随机安慰剂对照研究) *
Author(s) -
DOBS Adrian S.,
GOLDSTEIN Barry J.,
ASCHNER Pablo,
HORTON Edward S.,
UMPIERREZ Guillermo E.,
DURAN Lorraine,
HILL Julie S.,
CHEN Yu,
GOLM Gregory T.,
LANGDON Ronald B.,
WILLIAMSHERMAN Debora E.,
KAUFMAN Keith D.,
AMATRUDA John M.,
FERREIRA Juan Camilo ARJONA
Publication year - 2013
Publication title -
journal of diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.949
H-Index - 43
eISSN - 1753-0407
pISSN - 1753-0393
DOI - 10.1111/j.1753-0407.2012.00223.x
Subject(s) - sitagliptin , medicine , metformin , placebo , sitagliptin phosphate , rosiglitazone , adverse effect , type 2 diabetes , glycemic , dipeptidyl peptidase 4 inhibitor , randomized controlled trial , diabetes mellitus , gastroenterology , endocrinology , insulin , alternative medicine , pathology
Background: New therapeutic approaches are needed to improve glycemic control in patients with type 2 diabetes (T2D), a progressive disorder that often requires combination therapy. The present study assessed the efficacy and safety of sitagliptin as add‐on therapy to metformin and rosiglitazone in patients with T2D. Methods: The present study was a randomized double‐blind placebo‐controlled parallel‐group 54‐week study conducted at 41 sites across North and South America, Europe, and Asia in 278 patients with HbA1c ranging from ≥7.5% to ≤11.0% despite ongoing combination therapy with metformin (≥1500 mg/day) and rosiglitazone (≥4 mg/day). Patients were randomized (2:1) to receive sitagliptin 100 mg or placebo once daily. The main outcome measure was change from baseline in HbA1c at Week 18. Results: Mean baseline HbA1c was 8.8%. The mean placebo‐adjusted change from baseline in HbA1c with sitagliptin treatment was −0.7% ( P < 0.001) at Week 18 and −0.8% ( P < 0.001) at Week 54. There were also significant ( P < 0.001) reductions in 2‐h post‐meal glucose and fasting plasma glucose compared with placebo at Weeks 18 and 54. Significantly higher proportions of sitagliptin‐ than placebo‐treated patients had HbA1c<7.0% at Weeks 18 (22% vs 9%; P = 0.003) and 54 (26% vs 14%; P = 0.015). Changes in body weight and the rates of adverse events overall, hypoglycemia, and gastrointestinal adverse events were similar in the sitagliptin and placebo groups during the 54‐week study. Conclusions: In patients with T2D, the addition of sitagliptin for 54 weeks to ongoing therapy with metformin and rosiglitazone improved glycemic control and was generally well tolerated compared with placebo.