Efficacy and safety of initial combination treatment with sitagliptin and pioglitazone-a factorial study

R. R. Henry, B. Staels, V. A. Fonseca, M. Z. Chou, R. Teng, G. T. Golm, R. B. Langdon, K. D. Kaufman, Helmut Steinberg, B. J. Goldstein

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Abstract

Aim: To evaluate the efficacy and safety of initial combination therapy of sitagliptin 100mg/day coadministered with all marketed doses of pioglitazone in patients with type 2 diabetes. Methods: Patients with A1c ≥7.5 and ≤11.0% were randomized among seven arms that received, once daily, 100mg sitagliptin alone; 15, 30 or 45mg pioglitazone alone, or 100mg sitagliptin plus 15, 30 or 45mg pioglitazone for 54weeks. The primary endpoint was change from baseline in A1c at week 24. Protocol-specified analyses compared combination therapies with monotherapies at respective dose-strengths and combination of sitagliptin plus pioglitazone 30mg with pioglitazone 45mg monotherapy. Post-hoc analyses compared sitagliptin plus pioglitazone 15mg with pioglitazone monotherapy at the two higher doses. Results: Initial combination therapy with sitagliptin and pioglitazone provided significantly greater reductions in A1c (0.4-0.7% differences) and other glycaemic endpoints than either monotherapy at the same doses. Combining sitagliptin with low-dose pioglitazone generally produced greater glycaemic improvements than higher doses of pioglitazone monotherapy (0.3-0.4% differences in A1c). Combination therapy was generally well tolerated; adverse events (AEs) of hypoglycaemia were reported with similar incidence (7.8-11.1%) in all treatment groups over the 54weeks of study; oedema was reported in 0.5% of patients in the sitagliptin monotherapy group and 2.7-5.3% among pioglitazone-treated groups. Significant weight gain was observed in all combination-treated groups compared with the sitagliptin monotherapy group. Conclusions: Initial combination therapy with sitagliptin and pioglitazone provided better glycaemic control than either monotherapy and was generally well tolerated.

Original languageEnglish (US)
Pages (from-to)223-230
Number of pages8
JournalDiabetes, Obesity and Metabolism
Volume16
Issue number3
DOIs
StatePublished - Jan 1 2014

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pioglitazone
Safety
Therapeutics
Sitagliptin Phosphate

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Henry, R. R., Staels, B., Fonseca, V. A., Chou, M. Z., Teng, R., Golm, G. T., ... Goldstein, B. J. (2014). Efficacy and safety of initial combination treatment with sitagliptin and pioglitazone-a factorial study. Diabetes, Obesity and Metabolism, 16(3), 223-230. https://doi.org/10.1111/dom.12194

Efficacy and safety of initial combination treatment with sitagliptin and pioglitazone-a factorial study. / Henry, R. R.; Staels, B.; Fonseca, V. A.; Chou, M. Z.; Teng, R.; Golm, G. T.; Langdon, R. B.; Kaufman, K. D.; Steinberg, Helmut; Goldstein, B. J.

In: Diabetes, Obesity and Metabolism, Vol. 16, No. 3, 01.01.2014, p. 223-230.

Research output: Contribution to journalArticle

Henry, RR, Staels, B, Fonseca, VA, Chou, MZ, Teng, R, Golm, GT, Langdon, RB, Kaufman, KD, Steinberg, H & Goldstein, BJ 2014, 'Efficacy and safety of initial combination treatment with sitagliptin and pioglitazone-a factorial study', Diabetes, Obesity and Metabolism, vol. 16, no. 3, pp. 223-230. https://doi.org/10.1111/dom.12194
Henry, R. R. ; Staels, B. ; Fonseca, V. A. ; Chou, M. Z. ; Teng, R. ; Golm, G. T. ; Langdon, R. B. ; Kaufman, K. D. ; Steinberg, Helmut ; Goldstein, B. J. / Efficacy and safety of initial combination treatment with sitagliptin and pioglitazone-a factorial study. In: Diabetes, Obesity and Metabolism. 2014 ; Vol. 16, No. 3. pp. 223-230.
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abstract = "Aim: To evaluate the efficacy and safety of initial combination therapy of sitagliptin 100mg/day coadministered with all marketed doses of pioglitazone in patients with type 2 diabetes. Methods: Patients with A1c ≥7.5 and ≤11.0{\%} were randomized among seven arms that received, once daily, 100mg sitagliptin alone; 15, 30 or 45mg pioglitazone alone, or 100mg sitagliptin plus 15, 30 or 45mg pioglitazone for 54weeks. The primary endpoint was change from baseline in A1c at week 24. Protocol-specified analyses compared combination therapies with monotherapies at respective dose-strengths and combination of sitagliptin plus pioglitazone 30mg with pioglitazone 45mg monotherapy. Post-hoc analyses compared sitagliptin plus pioglitazone 15mg with pioglitazone monotherapy at the two higher doses. Results: Initial combination therapy with sitagliptin and pioglitazone provided significantly greater reductions in A1c (0.4-0.7{\%} differences) and other glycaemic endpoints than either monotherapy at the same doses. Combining sitagliptin with low-dose pioglitazone generally produced greater glycaemic improvements than higher doses of pioglitazone monotherapy (0.3-0.4{\%} differences in A1c). Combination therapy was generally well tolerated; adverse events (AEs) of hypoglycaemia were reported with similar incidence (7.8-11.1{\%}) in all treatment groups over the 54weeks of study; oedema was reported in 0.5{\%} of patients in the sitagliptin monotherapy group and 2.7-5.3{\%} among pioglitazone-treated groups. Significant weight gain was observed in all combination-treated groups compared with the sitagliptin monotherapy group. Conclusions: Initial combination therapy with sitagliptin and pioglitazone provided better glycaemic control than either monotherapy and was generally well tolerated.",
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AU - Chou, M. Z.

AU - Teng, R.

AU - Golm, G. T.

AU - Langdon, R. B.

AU - Kaufman, K. D.

AU - Steinberg, Helmut

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N2 - Aim: To evaluate the efficacy and safety of initial combination therapy of sitagliptin 100mg/day coadministered with all marketed doses of pioglitazone in patients with type 2 diabetes. Methods: Patients with A1c ≥7.5 and ≤11.0% were randomized among seven arms that received, once daily, 100mg sitagliptin alone; 15, 30 or 45mg pioglitazone alone, or 100mg sitagliptin plus 15, 30 or 45mg pioglitazone for 54weeks. The primary endpoint was change from baseline in A1c at week 24. Protocol-specified analyses compared combination therapies with monotherapies at respective dose-strengths and combination of sitagliptin plus pioglitazone 30mg with pioglitazone 45mg monotherapy. Post-hoc analyses compared sitagliptin plus pioglitazone 15mg with pioglitazone monotherapy at the two higher doses. Results: Initial combination therapy with sitagliptin and pioglitazone provided significantly greater reductions in A1c (0.4-0.7% differences) and other glycaemic endpoints than either monotherapy at the same doses. Combining sitagliptin with low-dose pioglitazone generally produced greater glycaemic improvements than higher doses of pioglitazone monotherapy (0.3-0.4% differences in A1c). Combination therapy was generally well tolerated; adverse events (AEs) of hypoglycaemia were reported with similar incidence (7.8-11.1%) in all treatment groups over the 54weeks of study; oedema was reported in 0.5% of patients in the sitagliptin monotherapy group and 2.7-5.3% among pioglitazone-treated groups. Significant weight gain was observed in all combination-treated groups compared with the sitagliptin monotherapy group. Conclusions: Initial combination therapy with sitagliptin and pioglitazone provided better glycaemic control than either monotherapy and was generally well tolerated.

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