A randomized, double-blind, comparative therapy evaluating sitagliptin versus glibenclamide in type 2 diabetes patients already treated with pioglitazone and metformin: A 3-year study

Giuseppe Derosa, Arrigo F G Cicero, Ivano G. Franzetti, Fabrizio Querci, Anna Carbone, Mario N. Piccinni, Angela D'angelo, Elena Fogari, Pamela Maffioli

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Objectives: This study evaluated if triple oral therapy can be useful in improving glycemic control compared with metformin monotherapy and with a metformin and pioglitazone combination. Furthermore, we also compared a triple metformin+pioglitazone+glibenclamide combination with a metformin+pioglitazone+sitagliptin one. Subjects and Methods: After a 2-year run-in therapy-augmenting phase with metformin and pioglitazone, 453 overweight, type 2 diabetes patients were randomized to 1 year of sitagliptin versus 1 year of glibenclamide to evaluate, as the primary outcome, the variation of β-cell function both in a fasting state and after an euglycemic hyperinsulinemic and hyperglycemic clamp. As secondary outcomes we evaluated glycemic control and insulin resistance. Results: Both the triple therapy combinations were more effective in reducing glycated hemoglobin compared with metformin monotherapy and with dual therapy metformin+pioglitazone. Fasting plasma insulin level and the homeostasis model assessment insulin resistance index were significantly increased by triple therapy with glibenclamide and decreased by the one with sitagliptin. Although sitagliptin did not change the homeostasis model assessment β-function index, this value was significantly increased by glibenclamide. The fasting plasma proinsulin level was decreased by sitagliptin. Triple therapy with sitagliptin greatly improved β-cell function measures compared with the glibenclamide one and also compared with metformin monotherapy and with the metformin+pioglitazone combination. Conclusions: Dual combination therapy is more effective than monotherapy in improving glycemic control. When double therapy is not enough to reach an adequate glycemic control, sitagliptin should be preferred to glibenclamide as the third agent because of its positive effect on β-cells.

Original languageEnglish
Pages (from-to)214-222
Number of pages9
JournalDiabetes Technology and Therapeutics
Volume15
Issue number3
DOIs
Publication statusPublished - Mar 1 2013

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pioglitazone
Glyburide
Metformin
Type 2 Diabetes Mellitus
Fasting
Therapeutics
Insulin Resistance
Homeostasis
Sitagliptin Phosphate
Proinsulin
Glycosylated Hemoglobin A

ASJC Scopus subject areas

  • Endocrinology
  • Endocrinology, Diabetes and Metabolism
  • Medical Laboratory Technology

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A randomized, double-blind, comparative therapy evaluating sitagliptin versus glibenclamide in type 2 diabetes patients already treated with pioglitazone and metformin : A 3-year study. / Derosa, Giuseppe; Cicero, Arrigo F G; Franzetti, Ivano G.; Querci, Fabrizio; Carbone, Anna; Piccinni, Mario N.; D'angelo, Angela; Fogari, Elena; Maffioli, Pamela.

In: Diabetes Technology and Therapeutics, Vol. 15, No. 3, 01.03.2013, p. 214-222.

Research output: Contribution to journalArticle

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AU - Cicero, Arrigo F G

AU - Franzetti, Ivano G.

AU - Querci, Fabrizio

AU - Carbone, Anna

AU - Piccinni, Mario N.

AU - D'angelo, Angela

AU - Fogari, Elena

AU - Maffioli, Pamela

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