Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes andmoderate-to-severe chronic renal insufficiency

Juan Camilo Arjona Ferreira, Michel Marre, Nir Barzilai, Hua Guo, Gregory T. Golm, Christine McCrary Sisk, Keith D. Kaufman, Barry J. Goldstein

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE-Patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease have an increased risk ofmicro- and macrovascular disease, but limited options for antihyperglycemic therapy. We compared the efficacy and safety of sitagliptin with glipizide in patients with T2DM and moderate-to-severe chronic renal insufficiency and inadequate glycemic control. RESEARCH DESIGN AND METHODS-Patients (n = 426) were randomized 1:1 to sitagliptin (50 mg every day [q.d.] for moderate renal insufficiency and 25 mg q.d. for severe renal insufficiency) or glipizide (2.5 mg q.d., adjusted based on glycemic control to a 10-mg twice a day maximumdose). Randomization was stratified by: 1) renal status (moderate or severe renal insufficiency); 2) history of cardiovascular disease; and 3) history of heart failure. RESULTS-At week 54, treatment with sitagliptin was noninferior to treatment with glipizide in A1C change from baseline (20.8 vs. 20.6%; between-group difference 20.11%; 95% CI 20.29 to 0.06) because the upper bound of the 95% CI was less than the prespecified noninferiority margin of 0.4%. There was a lower incidence of symptomatic hypoglycemia adverse events (AEs) with sitagliptin versus glipizide (6.2 and 17.0%, respectively; P = 0.001) and a decrease in body weight with sitagliptin (20.6 kg) versus an increase (1.2 kg) with glipizide (difference, 21.8 kg; P < 0.001). The incidence of gastrointestinal AEs was low with both treatments. CONCLUSIONS-In patients with T2DM and chronic renal insufficiency, sitagliptin and glipizide provided similar A1C-lowering efficacy. Sitagliptin was generally well-tolerated, with a lower risk of hypoglycemia and weight loss versus weight gain, relative to glipizide.

Original languageEnglish (US)
Pages (from-to)1067-1073
Number of pages7
JournalDiabetes Care
Volume36
Issue number5
DOIs
StatePublished - May 2013

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Glipizide
Chronic Renal Insufficiency
Type 2 Diabetes Mellitus
Safety
Renal Insufficiency
Hypoglycemia
Incidence
Therapeutics
Random Allocation
Sitagliptin Phosphate
Hypoglycemic Agents
Weight Gain
Weight Loss
Research Design
Cardiovascular Diseases
Heart Failure
Body Weight
Kidney

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

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Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes andmoderate-to-severe chronic renal insufficiency. / Arjona Ferreira, Juan Camilo; Marre, Michel; Barzilai, Nir; Guo, Hua; Golm, Gregory T.; Sisk, Christine McCrary; Kaufman, Keith D.; Goldstein, Barry J.

In: Diabetes Care, Vol. 36, No. 5, 05.2013, p. 1067-1073.

Research output: Contribution to journalArticle

Arjona Ferreira, JC, Marre, M, Barzilai, N, Guo, H, Golm, GT, Sisk, CM, Kaufman, KD & Goldstein, BJ 2013, 'Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes andmoderate-to-severe chronic renal insufficiency', Diabetes Care, vol. 36, no. 5, pp. 1067-1073. https://doi.org/10.2337/dc12-1365
Arjona Ferreira, Juan Camilo ; Marre, Michel ; Barzilai, Nir ; Guo, Hua ; Golm, Gregory T. ; Sisk, Christine McCrary ; Kaufman, Keith D. ; Goldstein, Barry J. / Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes andmoderate-to-severe chronic renal insufficiency. In: Diabetes Care. 2013 ; Vol. 36, No. 5. pp. 1067-1073.
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T1 - Efficacy and safety of sitagliptin versus glipizide in patients with type 2 diabetes andmoderate-to-severe chronic renal insufficiency

AU - Arjona Ferreira, Juan Camilo

AU - Marre, Michel

AU - Barzilai, Nir

AU - Guo, Hua

AU - Golm, Gregory T.

AU - Sisk, Christine McCrary

AU - Kaufman, Keith D.

AU - Goldstein, Barry J.

PY - 2013/5

Y1 - 2013/5

N2 - OBJECTIVE-Patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease have an increased risk ofmicro- and macrovascular disease, but limited options for antihyperglycemic therapy. We compared the efficacy and safety of sitagliptin with glipizide in patients with T2DM and moderate-to-severe chronic renal insufficiency and inadequate glycemic control. RESEARCH DESIGN AND METHODS-Patients (n = 426) were randomized 1:1 to sitagliptin (50 mg every day [q.d.] for moderate renal insufficiency and 25 mg q.d. for severe renal insufficiency) or glipizide (2.5 mg q.d., adjusted based on glycemic control to a 10-mg twice a day maximumdose). Randomization was stratified by: 1) renal status (moderate or severe renal insufficiency); 2) history of cardiovascular disease; and 3) history of heart failure. RESULTS-At week 54, treatment with sitagliptin was noninferior to treatment with glipizide in A1C change from baseline (20.8 vs. 20.6%; between-group difference 20.11%; 95% CI 20.29 to 0.06) because the upper bound of the 95% CI was less than the prespecified noninferiority margin of 0.4%. There was a lower incidence of symptomatic hypoglycemia adverse events (AEs) with sitagliptin versus glipizide (6.2 and 17.0%, respectively; P = 0.001) and a decrease in body weight with sitagliptin (20.6 kg) versus an increase (1.2 kg) with glipizide (difference, 21.8 kg; P < 0.001). The incidence of gastrointestinal AEs was low with both treatments. CONCLUSIONS-In patients with T2DM and chronic renal insufficiency, sitagliptin and glipizide provided similar A1C-lowering efficacy. Sitagliptin was generally well-tolerated, with a lower risk of hypoglycemia and weight loss versus weight gain, relative to glipizide.

AB - OBJECTIVE-Patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease have an increased risk ofmicro- and macrovascular disease, but limited options for antihyperglycemic therapy. We compared the efficacy and safety of sitagliptin with glipizide in patients with T2DM and moderate-to-severe chronic renal insufficiency and inadequate glycemic control. RESEARCH DESIGN AND METHODS-Patients (n = 426) were randomized 1:1 to sitagliptin (50 mg every day [q.d.] for moderate renal insufficiency and 25 mg q.d. for severe renal insufficiency) or glipizide (2.5 mg q.d., adjusted based on glycemic control to a 10-mg twice a day maximumdose). Randomization was stratified by: 1) renal status (moderate or severe renal insufficiency); 2) history of cardiovascular disease; and 3) history of heart failure. RESULTS-At week 54, treatment with sitagliptin was noninferior to treatment with glipizide in A1C change from baseline (20.8 vs. 20.6%; between-group difference 20.11%; 95% CI 20.29 to 0.06) because the upper bound of the 95% CI was less than the prespecified noninferiority margin of 0.4%. There was a lower incidence of symptomatic hypoglycemia adverse events (AEs) with sitagliptin versus glipizide (6.2 and 17.0%, respectively; P = 0.001) and a decrease in body weight with sitagliptin (20.6 kg) versus an increase (1.2 kg) with glipizide (difference, 21.8 kg; P < 0.001). The incidence of gastrointestinal AEs was low with both treatments. CONCLUSIONS-In patients with T2DM and chronic renal insufficiency, sitagliptin and glipizide provided similar A1C-lowering efficacy. Sitagliptin was generally well-tolerated, with a lower risk of hypoglycemia and weight loss versus weight gain, relative to glipizide.

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