Efficacy and safety of sitagliptin added to ongoing metformin and pioglitazone combination therapy in a randomized, placebo-controlled, 26-week trial in patients with type 2 diabetes

Vivian Fonseca, Bart Staels, Jerry D. Morgan, Yue Shentu, Gregory T. Golm, Amy O. Johnson-Levonas, Keith D. Kaufman, Barry J. Goldstein, Helmut Steinberg

Research output: Contribution to journalArticle

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Abstract

Aims: To assess efficacy and safety of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in combination therapy with metformin (≥ 1500 mg/day) and pioglitazone (≥ 30 mg/day) in patients with type 2 diabetes (T2DM) with inadequate glycemic control (hemoglobin A1c [HbA1c] ≥ 7.5% and ≤ 11%). Methods: This placebo-controlled, double-blind study included 313 patients, mean baseline HbA1c = 8.7%, who were randomized to receive sitagliptin 100 mg/day or placebo for 26 weeks. Results: The addition of sitagliptin led to significant (P <.001) mean changes from baseline relative to placebo in HbA1c (- 0.7%), fasting plasma glucose (- 1.0 mmol/L), and 2-h post-meal glucose (- 2.2 mmol/L). In patients with baseline HbA1c ≥ 9.0%, mean changes from baseline in HbA 1c were - 1.6% and - 0.8% for the sitagliptin and placebo groups, respectively (between-group difference -0.8%; P <.001). The incidences of reported adverse events were generally similar between the treatment groups. Incidences of symptomatic hypoglycemia were 7/157 [4.5%] and 6/156 [3.8%] in the sitagliptin and placebo groups, respectively (P =.786). Two patients, both in the placebo group, experienced an episode of hypoglycemia that required non-medical assistance. Conclusions: In this 26-week study, addition of sitagliptin to combination therapy with metformin and pioglitazone improved glycemic control and was generally well tolerated.

Original languageEnglish (US)
Pages (from-to)177-183
Number of pages7
JournalJournal of Diabetes and its Complications
Volume27
Issue number2
DOIs
StatePublished - Mar 1 2013
Externally publishedYes

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pioglitazone
Metformin
Type 2 Diabetes Mellitus
Placebos
Safety
Hemoglobins
Hypoglycemia
Therapeutics
Dipeptidyl-Peptidase IV Inhibitors
Glucose
Incidence
Double-Blind Method
Meals
Sitagliptin Phosphate
Fasting

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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Efficacy and safety of sitagliptin added to ongoing metformin and pioglitazone combination therapy in a randomized, placebo-controlled, 26-week trial in patients with type 2 diabetes. / Fonseca, Vivian; Staels, Bart; Morgan, Jerry D.; Shentu, Yue; Golm, Gregory T.; Johnson-Levonas, Amy O.; Kaufman, Keith D.; Goldstein, Barry J.; Steinberg, Helmut.

In: Journal of Diabetes and its Complications, Vol. 27, No. 2, 01.03.2013, p. 177-183.

Research output: Contribution to journalArticle

Fonseca, Vivian ; Staels, Bart ; Morgan, Jerry D. ; Shentu, Yue ; Golm, Gregory T. ; Johnson-Levonas, Amy O. ; Kaufman, Keith D. ; Goldstein, Barry J. ; Steinberg, Helmut. / Efficacy and safety of sitagliptin added to ongoing metformin and pioglitazone combination therapy in a randomized, placebo-controlled, 26-week trial in patients with type 2 diabetes. In: Journal of Diabetes and its Complications. 2013 ; Vol. 27, No. 2. pp. 177-183.
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abstract = "Aims: To assess efficacy and safety of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in combination therapy with metformin (≥ 1500 mg/day) and pioglitazone (≥ 30 mg/day) in patients with type 2 diabetes (T2DM) with inadequate glycemic control (hemoglobin A1c [HbA1c] ≥ 7.5{\%} and ≤ 11{\%}). Methods: This placebo-controlled, double-blind study included 313 patients, mean baseline HbA1c = 8.7{\%}, who were randomized to receive sitagliptin 100 mg/day or placebo for 26 weeks. Results: The addition of sitagliptin led to significant (P <.001) mean changes from baseline relative to placebo in HbA1c (- 0.7{\%}), fasting plasma glucose (- 1.0 mmol/L), and 2-h post-meal glucose (- 2.2 mmol/L). In patients with baseline HbA1c ≥ 9.0{\%}, mean changes from baseline in HbA 1c were - 1.6{\%} and - 0.8{\%} for the sitagliptin and placebo groups, respectively (between-group difference -0.8{\%}; P <.001). The incidences of reported adverse events were generally similar between the treatment groups. Incidences of symptomatic hypoglycemia were 7/157 [4.5{\%}] and 6/156 [3.8{\%}] in the sitagliptin and placebo groups, respectively (P =.786). Two patients, both in the placebo group, experienced an episode of hypoglycemia that required non-medical assistance. Conclusions: In this 26-week study, addition of sitagliptin to combination therapy with metformin and pioglitazone improved glycemic control and was generally well tolerated.",
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T1 - Efficacy and safety of sitagliptin added to ongoing metformin and pioglitazone combination therapy in a randomized, placebo-controlled, 26-week trial in patients with type 2 diabetes

AU - Fonseca, Vivian

AU - Staels, Bart

AU - Morgan, Jerry D.

AU - Shentu, Yue

AU - Golm, Gregory T.

AU - Johnson-Levonas, Amy O.

AU - Kaufman, Keith D.

AU - Goldstein, Barry J.

AU - Steinberg, Helmut

PY - 2013/3/1

Y1 - 2013/3/1

N2 - Aims: To assess efficacy and safety of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in combination therapy with metformin (≥ 1500 mg/day) and pioglitazone (≥ 30 mg/day) in patients with type 2 diabetes (T2DM) with inadequate glycemic control (hemoglobin A1c [HbA1c] ≥ 7.5% and ≤ 11%). Methods: This placebo-controlled, double-blind study included 313 patients, mean baseline HbA1c = 8.7%, who were randomized to receive sitagliptin 100 mg/day or placebo for 26 weeks. Results: The addition of sitagliptin led to significant (P <.001) mean changes from baseline relative to placebo in HbA1c (- 0.7%), fasting plasma glucose (- 1.0 mmol/L), and 2-h post-meal glucose (- 2.2 mmol/L). In patients with baseline HbA1c ≥ 9.0%, mean changes from baseline in HbA 1c were - 1.6% and - 0.8% for the sitagliptin and placebo groups, respectively (between-group difference -0.8%; P <.001). The incidences of reported adverse events were generally similar between the treatment groups. Incidences of symptomatic hypoglycemia were 7/157 [4.5%] and 6/156 [3.8%] in the sitagliptin and placebo groups, respectively (P =.786). Two patients, both in the placebo group, experienced an episode of hypoglycemia that required non-medical assistance. Conclusions: In this 26-week study, addition of sitagliptin to combination therapy with metformin and pioglitazone improved glycemic control and was generally well tolerated.

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