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Barry J. Goldstein - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and Safety of Sitagliptin Versus Glipizide in PatientsWith Type 2 Diabetes andModerate-to-Severe Chronic Renal Insufficiency
2016Co-Authors: Juan Camilo, Arjona Ferreira, Michel Marre, Nir Barzilai, Hua Guo, Gregory T. Golm, Christine Mccrary Sisk, Keith D. Kaufman, Barry J. GoldsteinAbstract:OBJECTIVEdPatients with type 2 diabetes mellitus (T2DM) and chronic kidney disease have an increased risk of micro- 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 METHODSdPatients (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 maximum dose). Randomization was stratified by: 1) renal status (moderate or severe renal insufficiency); 2) history of cardiovascular disease; and 3) history of heart failure. RESULTSdAt 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 non-inferiority 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 glipizid
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efficacy and safety of sitagliptin versus Glipizide in patients with type 2 diabetes and moderate to severe chronic renal insufficiency
Diabetes Care, 2013Co-Authors: Juan Camilo Arjona Ferreira, Michel Marre, Nir Barzilai, Gregory T. Golm, Christine Mccrary Sisk, Keith D. Kaufman, Barry J. GoldsteinAbstract:OBJECTIVE Patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease have an increased risk of micro- 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 maximum dose). 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 (−0.8 vs. −0.6%; between-group difference −0.11%; 95% CI −0.29 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 (−0.6 kg) versus an increase (1.2 kg) with Glipizide (difference, −1.8 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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multicenter randomized double masked parallel group assessment of simultaneous Glipizide metformin as second line pharmacologic treatment for patients with type 2 diabetes mellitus that is inadequately controlled by a sulfonylurea
Clinical Therapeutics, 2003Co-Authors: Barry J. Goldstein, Miranda Pans, Cindy J RubinAbstract:Abstract Background: Many patients with type 2 diabetes mellitus (DM) with inadequate long-term blood glucose control with sulfonylurea or metformin monotherapy require additional treatment. The synergistic effects of combining Glipizide with metformin on glucose control may be realized by treating the primary effects of type 2 DM, impaired insulin secretion, and insulin resistance. Objective: This study assessed therapy with Glipizide/metformin combination tablets in patients with type 2 DM that is uncontrolled by at least half the maximum labeled daily dose of a sulfonylurea. Methods: In this multicenter, double-masked, parallel-group, active-controlled study, patients were randomized to receive Glipizide 30-mg, metformin 500-mg, or Glipizide/metformin 5500 mg tablets for 18 weeks (metformin and Glipizide/metformin doses were titrated to achieve blood glucose control). Maximum total daily doses were Glipizide 30 mg, metformin 2000 mg, and Glipizide/metformin 202000mg. Results: A total of 247 patients were included in the study. The mean (SD) age was 56.2 (10.1) years; 61.5% of patients were male; 70.0% were white, 15.8% were Hispanic/Latino, 13.0% were black, and 1.2% were Asian/Pacific Islanders.
Michel Marre - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and Safety of Sitagliptin Versus Glipizide in PatientsWith Type 2 Diabetes andModerate-to-Severe Chronic Renal Insufficiency
2016Co-Authors: Juan Camilo, Arjona Ferreira, Michel Marre, Nir Barzilai, Hua Guo, Gregory T. Golm, Christine Mccrary Sisk, Keith D. Kaufman, Barry J. GoldsteinAbstract:OBJECTIVEdPatients with type 2 diabetes mellitus (T2DM) and chronic kidney disease have an increased risk of micro- 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 METHODSdPatients (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 maximum dose). Randomization was stratified by: 1) renal status (moderate or severe renal insufficiency); 2) history of cardiovascular disease; and 3) history of heart failure. RESULTSdAt 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 non-inferiority 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 glipizid
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efficacy and safety of sitagliptin versus Glipizide in patients with type 2 diabetes and moderate to severe chronic renal insufficiency
Diabetes Care, 2013Co-Authors: Juan Camilo Arjona Ferreira, Michel Marre, Nir Barzilai, Gregory T. Golm, Christine Mccrary Sisk, Keith D. Kaufman, Barry J. GoldsteinAbstract:OBJECTIVE Patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease have an increased risk of micro- 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 maximum dose). 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 (−0.8 vs. −0.6%; between-group difference −0.11%; 95% CI −0.29 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 (−0.6 kg) versus an increase (1.2 kg) with Glipizide (difference, −1.8 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.
Juan Camilo Arjona Ferreira - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of sitagliptin versus Glipizide in patients with type 2 diabetes and moderate to severe chronic renal insufficiency
Diabetes Care, 2013Co-Authors: Juan Camilo Arjona Ferreira, Michel Marre, Nir Barzilai, Gregory T. Golm, Christine Mccrary Sisk, Keith D. Kaufman, Barry J. GoldsteinAbstract:OBJECTIVE Patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease have an increased risk of micro- 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 maximum dose). 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 (−0.8 vs. −0.6%; between-group difference −0.11%; 95% CI −0.29 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 (−0.6 kg) versus an increase (1.2 kg) with Glipizide (difference, −1.8 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.
Keith D. Kaufman - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and Safety of Sitagliptin Versus Glipizide in PatientsWith Type 2 Diabetes andModerate-to-Severe Chronic Renal Insufficiency
2016Co-Authors: Juan Camilo, Arjona Ferreira, Michel Marre, Nir Barzilai, Hua Guo, Gregory T. Golm, Christine Mccrary Sisk, Keith D. Kaufman, Barry J. GoldsteinAbstract:OBJECTIVEdPatients with type 2 diabetes mellitus (T2DM) and chronic kidney disease have an increased risk of micro- 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 METHODSdPatients (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 maximum dose). Randomization was stratified by: 1) renal status (moderate or severe renal insufficiency); 2) history of cardiovascular disease; and 3) history of heart failure. RESULTSdAt 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 non-inferiority 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 glipizid
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efficacy and safety of sitagliptin versus Glipizide in patients with type 2 diabetes and moderate to severe chronic renal insufficiency
Diabetes Care, 2013Co-Authors: Juan Camilo Arjona Ferreira, Michel Marre, Nir Barzilai, Gregory T. Golm, Christine Mccrary Sisk, Keith D. Kaufman, Barry J. GoldsteinAbstract:OBJECTIVE Patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease have an increased risk of micro- 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 maximum dose). 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 (−0.8 vs. −0.6%; between-group difference −0.11%; 95% CI −0.29 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 (−0.6 kg) versus an increase (1.2 kg) with Glipizide (difference, −1.8 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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safety and efficacy of treatment with sitagliptin or Glipizide in patients with type 2 diabetes inadequately controlled on metformin a 2 year study
International Journal of Clinical Practice, 2010Co-Authors: Thomas Seck, Keith D. Kaufman, M A Nauck, D Sheng, Peter P Stein, S Sunga, Melanie J Davies, John M AmatrudaAbstract:Summary Objectives: To evaluate the 2-year safety and efficacy of adding sitagliptin or Glipizide to ongoing metformin in patients with type 2 diabetes. Methods: Patients who were on a stable dose of metformin (≥ 1500 mg/day) for at least 8 weeks were randomised in a double-blind manner to receive either sitagliptin 100 mg q.d. (N = 588) or Glipizide 5 mg/day (up-titrated up to 20 mg/day based upon prespecified glycaemic criteria) (N = 584). The efficacy analysis assessed the change in HbA1c from baseline using the per-protocol (PP) population. Results: For the PP cohort, mean baseline HbA1c was 7.3% in both groups. After 2 years, the least squares (LS) mean change in HbA1c from baseline [95% confidence interval (CI)] was −0.54% (−0.64, −0.45) with sitagliptin (n = 248) and −0.51% (−0.60, −0.42) with Glipizide (n = 256). The rise in HbA1c from week 24 to week 104 [i.e. coefficient of durability (COD)] was smaller with sitagliptin [COD (95% CI) 0.16%/year (0.10, 0.21)] compared with Glipizide [0.26%/year (0.21, 0.31)]. The proportion of patients with an HbA1c< 7% was 63% and 59% with sitagliptin and Glipizide, respectively. The beta-cell responsiveness to a meal challenge was maintained with sitagliptin and decreased with Glipizide. The proportion of patients who reported hypoglycaemia was 5% with sitagliptin and 34% with Glipizide [difference in proportions (95% CI) = −29% (−33, −25)]. Relative to baseline, sitagliptin was associated with weight loss (−1.6 kg) compared with weight gain (+0.7 kg) with Glipizide. Conclusion: In patients with type 2 diabetes, adding sitagliptin to metformin monotherapy improved glycaemic control over 2 years, similar to the glucose-lowering efficacy observed with adding Glipizide, but with greater durability and generally better maintenance of beta-cell function. Sitagliptin was generally well tolerated with a lower risk of hypoglycaemia and weight loss compared with weight gain observed with Glipizide.
Gregory T. Golm - One of the best experts on this subject based on the ideXlab platform.
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Efficacy and Safety of Sitagliptin Versus Glipizide in PatientsWith Type 2 Diabetes andModerate-to-Severe Chronic Renal Insufficiency
2016Co-Authors: Juan Camilo, Arjona Ferreira, Michel Marre, Nir Barzilai, Hua Guo, Gregory T. Golm, Christine Mccrary Sisk, Keith D. Kaufman, Barry J. GoldsteinAbstract:OBJECTIVEdPatients with type 2 diabetes mellitus (T2DM) and chronic kidney disease have an increased risk of micro- 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 METHODSdPatients (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 maximum dose). Randomization was stratified by: 1) renal status (moderate or severe renal insufficiency); 2) history of cardiovascular disease; and 3) history of heart failure. RESULTSdAt 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 non-inferiority 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 glipizid
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efficacy and safety of sitagliptin versus Glipizide in patients with type 2 diabetes and moderate to severe chronic renal insufficiency
Diabetes Care, 2013Co-Authors: Juan Camilo Arjona Ferreira, Michel Marre, Nir Barzilai, Gregory T. Golm, Christine Mccrary Sisk, Keith D. Kaufman, Barry J. GoldsteinAbstract:OBJECTIVE Patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease have an increased risk of micro- 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 maximum dose). 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 (−0.8 vs. −0.6%; between-group difference −0.11%; 95% CI −0.29 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 (−0.6 kg) versus an increase (1.2 kg) with Glipizide (difference, −1.8 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.