Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of β-cell function in patients with type 2 diabetes

K. H. Yoon, G. R. Shockey, R. Teng, G. T. Golm, P. R. Thakkar, A. G. Meehan, D. E. Williams-Herman, K. D. Kaufman, J. M. Amatruda, Helmut Steinberg

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Abstract

Aim/hypothesis: To assess the safety and efficacy of initial combination therapy with sitagliptin and pioglitazone compared with pioglitazone monotherapy in drug-naïve patients with type 2 diabetes. Methods: A total of 520 patients were randomised to initial combination therapy with sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. or pioglitazone 30 mg q.d. monotherapy for 24 weeks. Results: Initial combination therapy with sitagliptin and pioglitazone led to a mean reduction from baseline in A1C of -2.4% compared with -1.5% for pioglitazone monotherapy (p < 0.001). Mean reductions from baseline were greater in patients with a baseline A1C ≥ 10% (-3.0% with combination therapy vs. -2.1% with pioglitazone monotherapy) compared with patients with a baseline A1C < 10% (-2.0% with combination therapy vs. -1.1% with pioglitazone monotherapy). Sixty percent of patients in the combination therapy group vs. 28% in the pioglitazone monotherapy group had an A1C of < 7% at week 24 (p < 0.001). Fasting plasma glucose decreased by -63.0 mg/dl (-3.5 mmol/l) in the combination therapy group compared with -40.2 mg/dl (-2.2 mmol/l) for pioglitazone monotherapy (p < 0.001), and 2-h post meal glucose decreased by -113.6 mg/dl (-6.3 mmol/l) with combination therapy compared with -68.9 mg/dl (-3.8 mmol/l) for pioglitazone monotherapy (p < 0.001). Measures related to β-cell function also improved significantly with combination therapy compared with pioglitazone monotherapy. Combination therapy was generally well-tolerated compared with pioglitazone monotherapy, with similar incidences of hypoglycemia (1.1% and 0.8%, respectively), gastrointestinal adverse events (5.7% and 6.9%, respectively), and oedema (2.7% and 3.5%, respectively). Conclusion/interpretation: Initial combination therapy with sitagliptin and pioglitazone substantially improved glycemic control and was generally well-tolerated compared with pioglitazone monotherapy.

Original languageEnglish (US)
Pages (from-to)154-164
Number of pages11
JournalInternational Journal of Clinical Practice
Volume65
Issue number2
DOIs
StatePublished - Feb 1 2011
Externally publishedYes

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pioglitazone
Dipeptidyl-Peptidase IV Inhibitors
Type 2 Diabetes Mellitus
Therapeutics
Sitagliptin Phosphate
Group Psychotherapy

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of β-cell function in patients with type 2 diabetes. / Yoon, K. H.; Shockey, G. R.; Teng, R.; Golm, G. T.; Thakkar, P. R.; Meehan, A. G.; Williams-Herman, D. E.; Kaufman, K. D.; Amatruda, J. M.; Steinberg, Helmut.

In: International Journal of Clinical Practice, Vol. 65, No. 2, 01.02.2011, p. 154-164.

Research output: Contribution to journalArticle

Yoon, K. H. ; Shockey, G. R. ; Teng, R. ; Golm, G. T. ; Thakkar, P. R. ; Meehan, A. G. ; Williams-Herman, D. E. ; Kaufman, K. D. ; Amatruda, J. M. ; Steinberg, Helmut. / Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of β-cell function in patients with type 2 diabetes. In: International Journal of Clinical Practice. 2011 ; Vol. 65, No. 2. pp. 154-164.
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abstract = "Aim/hypothesis: To assess the safety and efficacy of initial combination therapy with sitagliptin and pioglitazone compared with pioglitazone monotherapy in drug-na{\"i}ve patients with type 2 diabetes. Methods: A total of 520 patients were randomised to initial combination therapy with sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. or pioglitazone 30 mg q.d. monotherapy for 24 weeks. Results: Initial combination therapy with sitagliptin and pioglitazone led to a mean reduction from baseline in A1C of -2.4{\%} compared with -1.5{\%} for pioglitazone monotherapy (p < 0.001). Mean reductions from baseline were greater in patients with a baseline A1C ≥ 10{\%} (-3.0{\%} with combination therapy vs. -2.1{\%} with pioglitazone monotherapy) compared with patients with a baseline A1C < 10{\%} (-2.0{\%} with combination therapy vs. -1.1{\%} with pioglitazone monotherapy). Sixty percent of patients in the combination therapy group vs. 28{\%} in the pioglitazone monotherapy group had an A1C of < 7{\%} at week 24 (p < 0.001). Fasting plasma glucose decreased by -63.0 mg/dl (-3.5 mmol/l) in the combination therapy group compared with -40.2 mg/dl (-2.2 mmol/l) for pioglitazone monotherapy (p < 0.001), and 2-h post meal glucose decreased by -113.6 mg/dl (-6.3 mmol/l) with combination therapy compared with -68.9 mg/dl (-3.8 mmol/l) for pioglitazone monotherapy (p < 0.001). Measures related to β-cell function also improved significantly with combination therapy compared with pioglitazone monotherapy. Combination therapy was generally well-tolerated compared with pioglitazone monotherapy, with similar incidences of hypoglycemia (1.1{\%} and 0.8{\%}, respectively), gastrointestinal adverse events (5.7{\%} and 6.9{\%}, respectively), and oedema (2.7{\%} and 3.5{\%}, respectively). Conclusion/interpretation: Initial combination therapy with sitagliptin and pioglitazone substantially improved glycemic control and was generally well-tolerated compared with pioglitazone monotherapy.",
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T1 - Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and pioglitazone on glycemic control and measures of β-cell function in patients with type 2 diabetes

AU - Yoon, K. H.

AU - Shockey, G. R.

AU - Teng, R.

AU - Golm, G. T.

AU - Thakkar, P. R.

AU - Meehan, A. G.

AU - Williams-Herman, D. E.

AU - Kaufman, K. D.

AU - Amatruda, J. M.

AU - Steinberg, Helmut

PY - 2011/2/1

Y1 - 2011/2/1

N2 - Aim/hypothesis: To assess the safety and efficacy of initial combination therapy with sitagliptin and pioglitazone compared with pioglitazone monotherapy in drug-naïve patients with type 2 diabetes. Methods: A total of 520 patients were randomised to initial combination therapy with sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. or pioglitazone 30 mg q.d. monotherapy for 24 weeks. Results: Initial combination therapy with sitagliptin and pioglitazone led to a mean reduction from baseline in A1C of -2.4% compared with -1.5% for pioglitazone monotherapy (p < 0.001). Mean reductions from baseline were greater in patients with a baseline A1C ≥ 10% (-3.0% with combination therapy vs. -2.1% with pioglitazone monotherapy) compared with patients with a baseline A1C < 10% (-2.0% with combination therapy vs. -1.1% with pioglitazone monotherapy). Sixty percent of patients in the combination therapy group vs. 28% in the pioglitazone monotherapy group had an A1C of < 7% at week 24 (p < 0.001). Fasting plasma glucose decreased by -63.0 mg/dl (-3.5 mmol/l) in the combination therapy group compared with -40.2 mg/dl (-2.2 mmol/l) for pioglitazone monotherapy (p < 0.001), and 2-h post meal glucose decreased by -113.6 mg/dl (-6.3 mmol/l) with combination therapy compared with -68.9 mg/dl (-3.8 mmol/l) for pioglitazone monotherapy (p < 0.001). Measures related to β-cell function also improved significantly with combination therapy compared with pioglitazone monotherapy. Combination therapy was generally well-tolerated compared with pioglitazone monotherapy, with similar incidences of hypoglycemia (1.1% and 0.8%, respectively), gastrointestinal adverse events (5.7% and 6.9%, respectively), and oedema (2.7% and 3.5%, respectively). Conclusion/interpretation: Initial combination therapy with sitagliptin and pioglitazone substantially improved glycemic control and was generally well-tolerated compared with pioglitazone monotherapy.

AB - Aim/hypothesis: To assess the safety and efficacy of initial combination therapy with sitagliptin and pioglitazone compared with pioglitazone monotherapy in drug-naïve patients with type 2 diabetes. Methods: A total of 520 patients were randomised to initial combination therapy with sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. or pioglitazone 30 mg q.d. monotherapy for 24 weeks. Results: Initial combination therapy with sitagliptin and pioglitazone led to a mean reduction from baseline in A1C of -2.4% compared with -1.5% for pioglitazone monotherapy (p < 0.001). Mean reductions from baseline were greater in patients with a baseline A1C ≥ 10% (-3.0% with combination therapy vs. -2.1% with pioglitazone monotherapy) compared with patients with a baseline A1C < 10% (-2.0% with combination therapy vs. -1.1% with pioglitazone monotherapy). Sixty percent of patients in the combination therapy group vs. 28% in the pioglitazone monotherapy group had an A1C of < 7% at week 24 (p < 0.001). Fasting plasma glucose decreased by -63.0 mg/dl (-3.5 mmol/l) in the combination therapy group compared with -40.2 mg/dl (-2.2 mmol/l) for pioglitazone monotherapy (p < 0.001), and 2-h post meal glucose decreased by -113.6 mg/dl (-6.3 mmol/l) with combination therapy compared with -68.9 mg/dl (-3.8 mmol/l) for pioglitazone monotherapy (p < 0.001). Measures related to β-cell function also improved significantly with combination therapy compared with pioglitazone monotherapy. Combination therapy was generally well-tolerated compared with pioglitazone monotherapy, with similar incidences of hypoglycemia (1.1% and 0.8%, respectively), gastrointestinal adverse events (5.7% and 6.9%, respectively), and oedema (2.7% and 3.5%, respectively). Conclusion/interpretation: Initial combination therapy with sitagliptin and pioglitazone substantially improved glycemic control and was generally well-tolerated compared with pioglitazone monotherapy.

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