Efficacy 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

Adrian S. Dobs, Barry J. Goldstein, Pablo Aschner, Edward S. Horton, Guillermo E. Umpierrez, Lorraine Duran, Julie S. Hill, Yu Chen, Gregory T. Golm, Ronald B. Langdon, Debora E. Williams-Herman, Keith D. Kaufman, John M. Amatruda, Juan Camilo Arjona Ferreira

Research output: Contribution to journalArticlepeer-review

Abstract

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 (≥1500mg/day) and rosiglitazone (≥4mg/day). Patients were randomized (2:1) to receive sitagliptin 100mg 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 54weeks to ongoing therapy with metformin and rosiglitazone improved glycemic control and was generally well tolerated compared with placebo.

Original languageEnglish (US)
Pages (from-to)68-79
Number of pages12
JournalJournal of diabetes
Volume5
Issue number1
DOIs
StatePublished - Mar 2013

Keywords

  • Dipeptidyl peptidase-4 inhibitor
  • Glycemic control
  • Incretins
  • Sitagliptin

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism

Fingerprint Dive into the research topics of 'Efficacy 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'. Together they form a unique fingerprint.

Cite this