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Bo Ahrén - One of the best experts on this subject based on the ideXlab platform.

  • Higher Risk of Hypoglycemia with Glimepiride Versus Vildagliptin in Patients with Type 2 Diabetes is not Driven by High Doses of Glimepiride: Divergent Patient Susceptibilities?
    Diabetes Therapy, 2014
    Co-Authors: Bo Ahrén, Q Shao, Sylvie Dejager, James E. Foley, Mouna Akacha, Guenter Heimann, Markus Dworak, Anja Schweizer
    Abstract:

    Introduction In a previously published study, vildagliptin showed a reduced risk of hypoglycemia versus Glimepiride as add-on therapy to metformin at similar efficacy. Glimepiride was titrated from a starting dose of 2 mg/day to a maximum dose of 6 mg/day. It is usually assumed that the increased hypoglycemia with Glimepiride was driven by the 6 mg/day dose; it was therefore of interest to assess whether the risk of hypoglycemia is also different between vildagliptin and a low (2 mg/day) dose of Glimepiride.

  • harmony 3 104 week randomized double blind placebo and active controlled trial assessing the efficacy and safety of albiglutide compared with placebo sitagliptin and Glimepiride in patients with type 2 diabetes taking metformin
    Diabetes Care, 2014
    Co-Authors: Bo Ahrén, Susan L Johnson, Murray Stewart, Deborah T Cirkel, Fred Yang, Caroline Perry, Mark N Feinglos
    Abstract:

    OBJECTIVE To compare the efficacy and safety of weekly albiglutide with daily sitagliptin, daily Glimepiride, and placebo. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes receiving metformin were randomized to albiglutide (30 mg), sitagliptin (100 mg), Glimepiride (2 mg), or placebo. Blinded dose titration for albiglutide (to 50 mg) and Glimepiride (to 4 mg) was based on predefined hyperglycemia criteria. The primary end point was change in HbA 1c from baseline at week 104. Secondary end points included fasting plasma glucose (FPG), weight, and time to hyperglycemic rescue. RESULTS Baseline characteristics were similar among the albiglutide ( n = 302), Glimepiride ( n = 307), sitagliptin ( n = 302), and placebo ( n = 101) groups. Baseline HbA 1c was 8.1% (65.0 mmol/mol); mean age was 54.5 years. The mean doses for albiglutide and Glimepiride at week 104 were 40.5 and 3.1 mg, respectively. At week 104, albiglutide significantly reduced HbA 1c compared with placebo (−0.9% [−9.8 mmol/mol]; P P = 0.0001), and Glimepiride (−0.3% [−3.3 mmol/mol]; P = 0.0033). Outcomes for FPG and HbA 1c were similar. Weight change from baseline for each were as follows: albiglutide −1.21 kg (95% CI −1.68 to −0.74), placebo −1.00 kg (95% CI −1.81 to −0.20), sitagliptin −0.86 kg (95% CI −1.32 to −0.39), Glimepiride 1.17 kg (95% CI 0.70–1.63). The difference between albiglutide and Glimepiride was statistically significant ( P P P = 0.0118), and 32.7% ( P = 0.1504) for placebo, sitagliptin, and Glimepiride, respectively. Rates of serious adverse events in the albiglutide group were similar to comparison groups. Diarrhea (albiglutide 12.9%, other groups 8.6–10.9%) and nausea (albiglutide 10.3%, other groups 6.2–10.9%) were generally the most frequently reported gastrointestinal events. CONCLUSION Added to metformin, albiglutide was well-tolerated; produced superior reductions in HbA 1c and FPG at week 104 compared with placebo, sitagliptin, and Glimepiride; and resulted in weight loss compared with Glimepiride.

  • changes in prandial glucagon levels after a 2 year treatment with vildagliptin or Glimepiride in patients with type 2 diabetes inadequately controlled with metformin monotherapy
    Diabetes Care, 2010
    Co-Authors: Bo Ahrén, Sylvie Dejager, Eleuterio Ferrannini, Bernard Zinman, James E. Foley, David R Matthews, Vivian Fonseca
    Abstract:

    OBJECTIVE: To determine if the dipeptidyl peptidase-4 inhibitor vildagliptin more effectively inhibits glucagon levels than the sulfonylurea Glimepiride during a meal. RESEARCH DESIGN AND METHODS: Glucagon responses to a standard meal were measured at baseline and study end point (mean 1.8 years) in a trial evaluating add-on therapy to metformin with 50 mg vildagliptin b.i.d. compared with Glimepiride up to 6 mg q.d. in type 2 diabetes (baseline A1C 7.3 +/- 0.6%). RESULTS: A1C and prandial glucose area under the curve (AUC)(0-2 h) were reduced similarly in both groups, whereas prandial insulin AUC(0-2 h) increased to a greater extent by Glimepiride. Prandial glucagon AUC(0-2 h) (baseline 66.6 +/- 2.3 pmol . h(-1) . l(-1)) decreased by 3.4 +/- 1.6 pmol . h(-1) . l(-1) by vildagliptin (n = 137) and increased by 3.8 +/- 1.7 pmol . h(-1) . l(-1) by Glimepiride (n = 121). The between-group difference was 7.3 +/- 2.1 pmol . h(-1) . l(-1) (P < 0.001). CONCLUSIONS: Vildagliptin therapy but not Glimepiride improves postprandial alpha-cell function, which persists for at least 2 years.

  • fifty two week efficacy and safety of vildagliptin vs Glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy
    Diabetes Obesity and Metabolism, 2009
    Co-Authors: Eleuterio Ferrannini, D R Matthews, S Byiers, Q Shao, Vivian Fonseca, Bo Ahrén, Bernard Zinman, Sylvie Dejager
    Abstract:

    To examine the efficacy and safety of vildagliptin vs. Glimepiride as add-on therapy to metformin in patients with type 2 diabetes mellitus in a 52-week interim analysis of a large, randomized, double-blind, multicentre study. The primary objective was to demonstrate non-inferiority of vildagliptin vs. Glimepiride in glycosylated haemoglobin (HbA(1c)) reduction at week 52. Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) and receiving a stable dose of metformin (mean dose 1898 mg/day; mean duration of use 36 months) were randomized 1:1 to receive vildagliptin (50 mg twice daily, n = 1396) or Glimepiride (titrated up to 6 mg/day; mean dose 4.5 mg/day, n = 1393). Non-inferiority of vildagliptin was demonstrated (97.5% confidence interval 0.02%, 0.16%) with a mean (SE) change from baseline HbA(1c) (7.3% in both groups) to week 52 endpoint of -0.44% (0.02%) with vildagliptin and -0.53% (0.02%) with Glimepiride. Although a similar proportion of patients reached a target HbA(1c) level of < 7% with vildagliptin and Glimepiride (54.1 and 55.5%, respectively), a greater proportion of patients reached this target without hypoglycaemia in the vildagliptin group (50.9 vs. 44.3%; p < 0.01). Fasting plasma glucose (FPG) reductions were comparable between groups (mean [SE] -1.01 [0.06] mmol/l and -1.14 [0.06] mmol/l respectively). Vildagliptin significantly reduced body weight relative to Glimepiride (mean [SE] change from baseline -0.23 [0.11] kg; between-group difference -1.79 kg; p < 0.001) and resulted in a 10-fold lower incidence of hypoglycaemia than Glimepiride (1.7 vs. 16.2% of patients presenting at least one hypoglycaemic event; 39 vs. 554 hypoglycaemic events, p < 0.01). No severe hypoglycaemia occurred with vildagliptin compared with 10 episodes with Glimepiride (p < 0.01), and no patient in the vildagliptin group discontinued because of hypoglycaemia compared with 11 patients in the Glimepiride group. The incidence of adverse events (AEs), serious AEs and adjudicated cardiovascular events was 74.5, 7.1 and 0.9%, respectively, in patients receiving vildagliptin, and 81.1, 9.5 and 1.6%, respectively, in patients receiving Glimepiride. When metformin alone fails to maintain sufficient glycaemic control, the addition of vildagliptin provides comparable efficacy to that of Glimepiride after 52 weeks and displays a favourable AE profile, with no weight gain and a significant reduction in hypoglycaemia compared with Glimepiride. (Less)

  • fifty two week efficacy and safety of vildagliptin vs Glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy
    Diabetes Obesity and Metabolism, 2009
    Co-Authors: Eleuterio Ferrannini, D R Matthews, S Byiers, Q Shao, Vivian Fonseca, Bo Ahrén, Bernard Zinman, Sylvie Dejager
    Abstract:

    To examine the efficacy and safety of vildagliptin vs. Glimepiride as add-on therapy to metformin in patients with type 2 diabetes mellitus in a 52-week interim analysis of a large, randomized, double-blind, multicentre study. The primary objective was to demonstrate non-inferiority of vildagliptin vs. Glimepiride in glycosylated haemoglobin (HbA(1c)) reduction at week 52. Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) and receiving a stable dose of metformin (mean dose 1898 mg/day; mean duration of use 36 months) were randomized 1:1 to receive vildagliptin (50 mg twice daily, n = 1396) or Glimepiride (titrated up to 6 mg/day; mean dose 4.5 mg/day, n = 1393). Non-inferiority of vildagliptin was demonstrated (97.5% confidence interval 0.02%, 0.16%) with a mean (SE) change from baseline HbA(1c) (7.3% in both groups) to week 52 endpoint of -0.44% (0.02%) with vildagliptin and -0.53% (0.02%) with Glimepiride. Although a similar proportion of patients reached a target HbA(1c) level of < 7% with vildagliptin and Glimepiride (54.1 and 55.5%, respectively), a greater proportion of patients reached this target without hypoglycaemia in the vildagliptin group (50.9 vs. 44.3%; p < 0.01). Fasting plasma glucose (FPG) reductions were comparable between groups (mean [SE] -1.01 [0.06] mmol/l and -1.14 [0.06] mmol/l respectively). Vildagliptin significantly reduced body weight relative to Glimepiride (mean [SE] change from baseline -0.23 [0.11] kg; between-group difference -1.79 kg; p < 0.001) and resulted in a 10-fold lower incidence of hypoglycaemia than Glimepiride (1.7 vs. 16.2% of patients presenting at least one hypoglycaemic event; 39 vs. 554 hypoglycaemic events, p < 0.01). No severe hypoglycaemia occurred with vildagliptin compared with 10 episodes with Glimepiride (p < 0.01), and no patient in the vildagliptin group discontinued because of hypoglycaemia compared with 11 patients in the Glimepiride group. The incidence of adverse events (AEs), serious AEs and adjudicated cardiovascular events was 74.5, 7.1 and 0.9%, respectively, in patients receiving vildagliptin, and 81.1, 9.5 and 1.6%, respectively, in patients receiving Glimepiride. When metformin alone fails to maintain sufficient glycaemic control, the addition of vildagliptin provides comparable efficacy to that of Glimepiride after 52 weeks and displays a favourable AE profile, with no weight gain and a significant reduction in hypoglycaemia compared with Glimepiride. (Less)

Sylvie Dejager - One of the best experts on this subject based on the ideXlab platform.

  • Higher Risk of Hypoglycemia with Glimepiride Versus Vildagliptin in Patients with Type 2 Diabetes is not Driven by High Doses of Glimepiride: Divergent Patient Susceptibilities?
    Diabetes Therapy, 2014
    Co-Authors: Bo Ahrén, Q Shao, Sylvie Dejager, James E. Foley, Mouna Akacha, Guenter Heimann, Markus Dworak, Anja Schweizer
    Abstract:

    Introduction In a previously published study, vildagliptin showed a reduced risk of hypoglycemia versus Glimepiride as add-on therapy to metformin at similar efficacy. Glimepiride was titrated from a starting dose of 2 mg/day to a maximum dose of 6 mg/day. It is usually assumed that the increased hypoglycemia with Glimepiride was driven by the 6 mg/day dose; it was therefore of interest to assess whether the risk of hypoglycemia is also different between vildagliptin and a low (2 mg/day) dose of Glimepiride.

  • changes in prandial glucagon levels after a 2 year treatment with vildagliptin or Glimepiride in patients with type 2 diabetes inadequately controlled with metformin monotherapy
    Diabetes Care, 2010
    Co-Authors: Bo Ahrén, Sylvie Dejager, Eleuterio Ferrannini, Bernard Zinman, James E. Foley, David R Matthews, Vivian Fonseca
    Abstract:

    OBJECTIVE: To determine if the dipeptidyl peptidase-4 inhibitor vildagliptin more effectively inhibits glucagon levels than the sulfonylurea Glimepiride during a meal. RESEARCH DESIGN AND METHODS: Glucagon responses to a standard meal were measured at baseline and study end point (mean 1.8 years) in a trial evaluating add-on therapy to metformin with 50 mg vildagliptin b.i.d. compared with Glimepiride up to 6 mg q.d. in type 2 diabetes (baseline A1C 7.3 +/- 0.6%). RESULTS: A1C and prandial glucose area under the curve (AUC)(0-2 h) were reduced similarly in both groups, whereas prandial insulin AUC(0-2 h) increased to a greater extent by Glimepiride. Prandial glucagon AUC(0-2 h) (baseline 66.6 +/- 2.3 pmol . h(-1) . l(-1)) decreased by 3.4 +/- 1.6 pmol . h(-1) . l(-1) by vildagliptin (n = 137) and increased by 3.8 +/- 1.7 pmol . h(-1) . l(-1) by Glimepiride (n = 121). The between-group difference was 7.3 +/- 2.1 pmol . h(-1) . l(-1) (P < 0.001). CONCLUSIONS: Vildagliptin therapy but not Glimepiride improves postprandial alpha-cell function, which persists for at least 2 years.

  • fifty two week efficacy and safety of vildagliptin vs Glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy
    Diabetes Obesity and Metabolism, 2009
    Co-Authors: Eleuterio Ferrannini, D R Matthews, S Byiers, Q Shao, Vivian Fonseca, Bo Ahrén, Bernard Zinman, Sylvie Dejager
    Abstract:

    To examine the efficacy and safety of vildagliptin vs. Glimepiride as add-on therapy to metformin in patients with type 2 diabetes mellitus in a 52-week interim analysis of a large, randomized, double-blind, multicentre study. The primary objective was to demonstrate non-inferiority of vildagliptin vs. Glimepiride in glycosylated haemoglobin (HbA(1c)) reduction at week 52. Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) and receiving a stable dose of metformin (mean dose 1898 mg/day; mean duration of use 36 months) were randomized 1:1 to receive vildagliptin (50 mg twice daily, n = 1396) or Glimepiride (titrated up to 6 mg/day; mean dose 4.5 mg/day, n = 1393). Non-inferiority of vildagliptin was demonstrated (97.5% confidence interval 0.02%, 0.16%) with a mean (SE) change from baseline HbA(1c) (7.3% in both groups) to week 52 endpoint of -0.44% (0.02%) with vildagliptin and -0.53% (0.02%) with Glimepiride. Although a similar proportion of patients reached a target HbA(1c) level of < 7% with vildagliptin and Glimepiride (54.1 and 55.5%, respectively), a greater proportion of patients reached this target without hypoglycaemia in the vildagliptin group (50.9 vs. 44.3%; p < 0.01). Fasting plasma glucose (FPG) reductions were comparable between groups (mean [SE] -1.01 [0.06] mmol/l and -1.14 [0.06] mmol/l respectively). Vildagliptin significantly reduced body weight relative to Glimepiride (mean [SE] change from baseline -0.23 [0.11] kg; between-group difference -1.79 kg; p < 0.001) and resulted in a 10-fold lower incidence of hypoglycaemia than Glimepiride (1.7 vs. 16.2% of patients presenting at least one hypoglycaemic event; 39 vs. 554 hypoglycaemic events, p < 0.01). No severe hypoglycaemia occurred with vildagliptin compared with 10 episodes with Glimepiride (p < 0.01), and no patient in the vildagliptin group discontinued because of hypoglycaemia compared with 11 patients in the Glimepiride group. The incidence of adverse events (AEs), serious AEs and adjudicated cardiovascular events was 74.5, 7.1 and 0.9%, respectively, in patients receiving vildagliptin, and 81.1, 9.5 and 1.6%, respectively, in patients receiving Glimepiride. When metformin alone fails to maintain sufficient glycaemic control, the addition of vildagliptin provides comparable efficacy to that of Glimepiride after 52 weeks and displays a favourable AE profile, with no weight gain and a significant reduction in hypoglycaemia compared with Glimepiride. (Less)

  • fifty two week efficacy and safety of vildagliptin vs Glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy
    Diabetes Obesity and Metabolism, 2009
    Co-Authors: Eleuterio Ferrannini, D R Matthews, S Byiers, Q Shao, Vivian Fonseca, Bo Ahrén, Bernard Zinman, Sylvie Dejager
    Abstract:

    To examine the efficacy and safety of vildagliptin vs. Glimepiride as add-on therapy to metformin in patients with type 2 diabetes mellitus in a 52-week interim analysis of a large, randomized, double-blind, multicentre study. The primary objective was to demonstrate non-inferiority of vildagliptin vs. Glimepiride in glycosylated haemoglobin (HbA(1c)) reduction at week 52. Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) and receiving a stable dose of metformin (mean dose 1898 mg/day; mean duration of use 36 months) were randomized 1:1 to receive vildagliptin (50 mg twice daily, n = 1396) or Glimepiride (titrated up to 6 mg/day; mean dose 4.5 mg/day, n = 1393). Non-inferiority of vildagliptin was demonstrated (97.5% confidence interval 0.02%, 0.16%) with a mean (SE) change from baseline HbA(1c) (7.3% in both groups) to week 52 endpoint of -0.44% (0.02%) with vildagliptin and -0.53% (0.02%) with Glimepiride. Although a similar proportion of patients reached a target HbA(1c) level of < 7% with vildagliptin and Glimepiride (54.1 and 55.5%, respectively), a greater proportion of patients reached this target without hypoglycaemia in the vildagliptin group (50.9 vs. 44.3%; p < 0.01). Fasting plasma glucose (FPG) reductions were comparable between groups (mean [SE] -1.01 [0.06] mmol/l and -1.14 [0.06] mmol/l respectively). Vildagliptin significantly reduced body weight relative to Glimepiride (mean [SE] change from baseline -0.23 [0.11] kg; between-group difference -1.79 kg; p < 0.001) and resulted in a 10-fold lower incidence of hypoglycaemia than Glimepiride (1.7 vs. 16.2% of patients presenting at least one hypoglycaemic event; 39 vs. 554 hypoglycaemic events, p < 0.01). No severe hypoglycaemia occurred with vildagliptin compared with 10 episodes with Glimepiride (p < 0.01), and no patient in the vildagliptin group discontinued because of hypoglycaemia compared with 11 patients in the Glimepiride group. The incidence of adverse events (AEs), serious AEs and adjudicated cardiovascular events was 74.5, 7.1 and 0.9%, respectively, in patients receiving vildagliptin, and 81.1, 9.5 and 1.6%, respectively, in patients receiving Glimepiride. When metformin alone fails to maintain sufficient glycaemic control, the addition of vildagliptin provides comparable efficacy to that of Glimepiride after 52 weeks and displays a favourable AE profile, with no weight gain and a significant reduction in hypoglycaemia compared with Glimepiride. (Less)

Vivian Fonseca - One of the best experts on this subject based on the ideXlab platform.

  • changes in prandial glucagon levels after a 2 year treatment with vildagliptin or Glimepiride in patients with type 2 diabetes inadequately controlled with metformin monotherapy
    Diabetes Care, 2010
    Co-Authors: Bo Ahrén, Sylvie Dejager, Eleuterio Ferrannini, Bernard Zinman, James E. Foley, David R Matthews, Vivian Fonseca
    Abstract:

    OBJECTIVE: To determine if the dipeptidyl peptidase-4 inhibitor vildagliptin more effectively inhibits glucagon levels than the sulfonylurea Glimepiride during a meal. RESEARCH DESIGN AND METHODS: Glucagon responses to a standard meal were measured at baseline and study end point (mean 1.8 years) in a trial evaluating add-on therapy to metformin with 50 mg vildagliptin b.i.d. compared with Glimepiride up to 6 mg q.d. in type 2 diabetes (baseline A1C 7.3 +/- 0.6%). RESULTS: A1C and prandial glucose area under the curve (AUC)(0-2 h) were reduced similarly in both groups, whereas prandial insulin AUC(0-2 h) increased to a greater extent by Glimepiride. Prandial glucagon AUC(0-2 h) (baseline 66.6 +/- 2.3 pmol . h(-1) . l(-1)) decreased by 3.4 +/- 1.6 pmol . h(-1) . l(-1) by vildagliptin (n = 137) and increased by 3.8 +/- 1.7 pmol . h(-1) . l(-1) by Glimepiride (n = 121). The between-group difference was 7.3 +/- 2.1 pmol . h(-1) . l(-1) (P < 0.001). CONCLUSIONS: Vildagliptin therapy but not Glimepiride improves postprandial alpha-cell function, which persists for at least 2 years.

  • fifty two week efficacy and safety of vildagliptin vs Glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy
    Diabetes Obesity and Metabolism, 2009
    Co-Authors: Eleuterio Ferrannini, D R Matthews, S Byiers, Q Shao, Vivian Fonseca, Bo Ahrén, Bernard Zinman, Sylvie Dejager
    Abstract:

    To examine the efficacy and safety of vildagliptin vs. Glimepiride as add-on therapy to metformin in patients with type 2 diabetes mellitus in a 52-week interim analysis of a large, randomized, double-blind, multicentre study. The primary objective was to demonstrate non-inferiority of vildagliptin vs. Glimepiride in glycosylated haemoglobin (HbA(1c)) reduction at week 52. Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) and receiving a stable dose of metformin (mean dose 1898 mg/day; mean duration of use 36 months) were randomized 1:1 to receive vildagliptin (50 mg twice daily, n = 1396) or Glimepiride (titrated up to 6 mg/day; mean dose 4.5 mg/day, n = 1393). Non-inferiority of vildagliptin was demonstrated (97.5% confidence interval 0.02%, 0.16%) with a mean (SE) change from baseline HbA(1c) (7.3% in both groups) to week 52 endpoint of -0.44% (0.02%) with vildagliptin and -0.53% (0.02%) with Glimepiride. Although a similar proportion of patients reached a target HbA(1c) level of < 7% with vildagliptin and Glimepiride (54.1 and 55.5%, respectively), a greater proportion of patients reached this target without hypoglycaemia in the vildagliptin group (50.9 vs. 44.3%; p < 0.01). Fasting plasma glucose (FPG) reductions were comparable between groups (mean [SE] -1.01 [0.06] mmol/l and -1.14 [0.06] mmol/l respectively). Vildagliptin significantly reduced body weight relative to Glimepiride (mean [SE] change from baseline -0.23 [0.11] kg; between-group difference -1.79 kg; p < 0.001) and resulted in a 10-fold lower incidence of hypoglycaemia than Glimepiride (1.7 vs. 16.2% of patients presenting at least one hypoglycaemic event; 39 vs. 554 hypoglycaemic events, p < 0.01). No severe hypoglycaemia occurred with vildagliptin compared with 10 episodes with Glimepiride (p < 0.01), and no patient in the vildagliptin group discontinued because of hypoglycaemia compared with 11 patients in the Glimepiride group. The incidence of adverse events (AEs), serious AEs and adjudicated cardiovascular events was 74.5, 7.1 and 0.9%, respectively, in patients receiving vildagliptin, and 81.1, 9.5 and 1.6%, respectively, in patients receiving Glimepiride. When metformin alone fails to maintain sufficient glycaemic control, the addition of vildagliptin provides comparable efficacy to that of Glimepiride after 52 weeks and displays a favourable AE profile, with no weight gain and a significant reduction in hypoglycaemia compared with Glimepiride. (Less)

  • fifty two week efficacy and safety of vildagliptin vs Glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy
    Diabetes Obesity and Metabolism, 2009
    Co-Authors: Eleuterio Ferrannini, D R Matthews, S Byiers, Q Shao, Vivian Fonseca, Bo Ahrén, Bernard Zinman, Sylvie Dejager
    Abstract:

    To examine the efficacy and safety of vildagliptin vs. Glimepiride as add-on therapy to metformin in patients with type 2 diabetes mellitus in a 52-week interim analysis of a large, randomized, double-blind, multicentre study. The primary objective was to demonstrate non-inferiority of vildagliptin vs. Glimepiride in glycosylated haemoglobin (HbA(1c)) reduction at week 52. Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) and receiving a stable dose of metformin (mean dose 1898 mg/day; mean duration of use 36 months) were randomized 1:1 to receive vildagliptin (50 mg twice daily, n = 1396) or Glimepiride (titrated up to 6 mg/day; mean dose 4.5 mg/day, n = 1393). Non-inferiority of vildagliptin was demonstrated (97.5% confidence interval 0.02%, 0.16%) with a mean (SE) change from baseline HbA(1c) (7.3% in both groups) to week 52 endpoint of -0.44% (0.02%) with vildagliptin and -0.53% (0.02%) with Glimepiride. Although a similar proportion of patients reached a target HbA(1c) level of < 7% with vildagliptin and Glimepiride (54.1 and 55.5%, respectively), a greater proportion of patients reached this target without hypoglycaemia in the vildagliptin group (50.9 vs. 44.3%; p < 0.01). Fasting plasma glucose (FPG) reductions were comparable between groups (mean [SE] -1.01 [0.06] mmol/l and -1.14 [0.06] mmol/l respectively). Vildagliptin significantly reduced body weight relative to Glimepiride (mean [SE] change from baseline -0.23 [0.11] kg; between-group difference -1.79 kg; p < 0.001) and resulted in a 10-fold lower incidence of hypoglycaemia than Glimepiride (1.7 vs. 16.2% of patients presenting at least one hypoglycaemic event; 39 vs. 554 hypoglycaemic events, p < 0.01). No severe hypoglycaemia occurred with vildagliptin compared with 10 episodes with Glimepiride (p < 0.01), and no patient in the vildagliptin group discontinued because of hypoglycaemia compared with 11 patients in the Glimepiride group. The incidence of adverse events (AEs), serious AEs and adjudicated cardiovascular events was 74.5, 7.1 and 0.9%, respectively, in patients receiving vildagliptin, and 81.1, 9.5 and 1.6%, respectively, in patients receiving Glimepiride. When metformin alone fails to maintain sufficient glycaemic control, the addition of vildagliptin provides comparable efficacy to that of Glimepiride after 52 weeks and displays a favourable AE profile, with no weight gain and a significant reduction in hypoglycaemia compared with Glimepiride. (Less)

Eleuterio Ferrannini - One of the best experts on this subject based on the ideXlab platform.

  • changes in prandial glucagon levels after a 2 year treatment with vildagliptin or Glimepiride in patients with type 2 diabetes inadequately controlled with metformin monotherapy
    Diabetes Care, 2010
    Co-Authors: Bo Ahrén, Sylvie Dejager, Eleuterio Ferrannini, Bernard Zinman, James E. Foley, David R Matthews, Vivian Fonseca
    Abstract:

    OBJECTIVE: To determine if the dipeptidyl peptidase-4 inhibitor vildagliptin more effectively inhibits glucagon levels than the sulfonylurea Glimepiride during a meal. RESEARCH DESIGN AND METHODS: Glucagon responses to a standard meal were measured at baseline and study end point (mean 1.8 years) in a trial evaluating add-on therapy to metformin with 50 mg vildagliptin b.i.d. compared with Glimepiride up to 6 mg q.d. in type 2 diabetes (baseline A1C 7.3 +/- 0.6%). RESULTS: A1C and prandial glucose area under the curve (AUC)(0-2 h) were reduced similarly in both groups, whereas prandial insulin AUC(0-2 h) increased to a greater extent by Glimepiride. Prandial glucagon AUC(0-2 h) (baseline 66.6 +/- 2.3 pmol . h(-1) . l(-1)) decreased by 3.4 +/- 1.6 pmol . h(-1) . l(-1) by vildagliptin (n = 137) and increased by 3.8 +/- 1.7 pmol . h(-1) . l(-1) by Glimepiride (n = 121). The between-group difference was 7.3 +/- 2.1 pmol . h(-1) . l(-1) (P < 0.001). CONCLUSIONS: Vildagliptin therapy but not Glimepiride improves postprandial alpha-cell function, which persists for at least 2 years.

  • fifty two week efficacy and safety of vildagliptin vs Glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy
    Diabetes Obesity and Metabolism, 2009
    Co-Authors: Eleuterio Ferrannini, D R Matthews, S Byiers, Q Shao, Vivian Fonseca, Bo Ahrén, Bernard Zinman, Sylvie Dejager
    Abstract:

    To examine the efficacy and safety of vildagliptin vs. Glimepiride as add-on therapy to metformin in patients with type 2 diabetes mellitus in a 52-week interim analysis of a large, randomized, double-blind, multicentre study. The primary objective was to demonstrate non-inferiority of vildagliptin vs. Glimepiride in glycosylated haemoglobin (HbA(1c)) reduction at week 52. Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) and receiving a stable dose of metformin (mean dose 1898 mg/day; mean duration of use 36 months) were randomized 1:1 to receive vildagliptin (50 mg twice daily, n = 1396) or Glimepiride (titrated up to 6 mg/day; mean dose 4.5 mg/day, n = 1393). Non-inferiority of vildagliptin was demonstrated (97.5% confidence interval 0.02%, 0.16%) with a mean (SE) change from baseline HbA(1c) (7.3% in both groups) to week 52 endpoint of -0.44% (0.02%) with vildagliptin and -0.53% (0.02%) with Glimepiride. Although a similar proportion of patients reached a target HbA(1c) level of < 7% with vildagliptin and Glimepiride (54.1 and 55.5%, respectively), a greater proportion of patients reached this target without hypoglycaemia in the vildagliptin group (50.9 vs. 44.3%; p < 0.01). Fasting plasma glucose (FPG) reductions were comparable between groups (mean [SE] -1.01 [0.06] mmol/l and -1.14 [0.06] mmol/l respectively). Vildagliptin significantly reduced body weight relative to Glimepiride (mean [SE] change from baseline -0.23 [0.11] kg; between-group difference -1.79 kg; p < 0.001) and resulted in a 10-fold lower incidence of hypoglycaemia than Glimepiride (1.7 vs. 16.2% of patients presenting at least one hypoglycaemic event; 39 vs. 554 hypoglycaemic events, p < 0.01). No severe hypoglycaemia occurred with vildagliptin compared with 10 episodes with Glimepiride (p < 0.01), and no patient in the vildagliptin group discontinued because of hypoglycaemia compared with 11 patients in the Glimepiride group. The incidence of adverse events (AEs), serious AEs and adjudicated cardiovascular events was 74.5, 7.1 and 0.9%, respectively, in patients receiving vildagliptin, and 81.1, 9.5 and 1.6%, respectively, in patients receiving Glimepiride. When metformin alone fails to maintain sufficient glycaemic control, the addition of vildagliptin provides comparable efficacy to that of Glimepiride after 52 weeks and displays a favourable AE profile, with no weight gain and a significant reduction in hypoglycaemia compared with Glimepiride. (Less)

  • fifty two week efficacy and safety of vildagliptin vs Glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy
    Diabetes Obesity and Metabolism, 2009
    Co-Authors: Eleuterio Ferrannini, D R Matthews, S Byiers, Q Shao, Vivian Fonseca, Bo Ahrén, Bernard Zinman, Sylvie Dejager
    Abstract:

    To examine the efficacy and safety of vildagliptin vs. Glimepiride as add-on therapy to metformin in patients with type 2 diabetes mellitus in a 52-week interim analysis of a large, randomized, double-blind, multicentre study. The primary objective was to demonstrate non-inferiority of vildagliptin vs. Glimepiride in glycosylated haemoglobin (HbA(1c)) reduction at week 52. Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) and receiving a stable dose of metformin (mean dose 1898 mg/day; mean duration of use 36 months) were randomized 1:1 to receive vildagliptin (50 mg twice daily, n = 1396) or Glimepiride (titrated up to 6 mg/day; mean dose 4.5 mg/day, n = 1393). Non-inferiority of vildagliptin was demonstrated (97.5% confidence interval 0.02%, 0.16%) with a mean (SE) change from baseline HbA(1c) (7.3% in both groups) to week 52 endpoint of -0.44% (0.02%) with vildagliptin and -0.53% (0.02%) with Glimepiride. Although a similar proportion of patients reached a target HbA(1c) level of < 7% with vildagliptin and Glimepiride (54.1 and 55.5%, respectively), a greater proportion of patients reached this target without hypoglycaemia in the vildagliptin group (50.9 vs. 44.3%; p < 0.01). Fasting plasma glucose (FPG) reductions were comparable between groups (mean [SE] -1.01 [0.06] mmol/l and -1.14 [0.06] mmol/l respectively). Vildagliptin significantly reduced body weight relative to Glimepiride (mean [SE] change from baseline -0.23 [0.11] kg; between-group difference -1.79 kg; p < 0.001) and resulted in a 10-fold lower incidence of hypoglycaemia than Glimepiride (1.7 vs. 16.2% of patients presenting at least one hypoglycaemic event; 39 vs. 554 hypoglycaemic events, p < 0.01). No severe hypoglycaemia occurred with vildagliptin compared with 10 episodes with Glimepiride (p < 0.01), and no patient in the vildagliptin group discontinued because of hypoglycaemia compared with 11 patients in the Glimepiride group. The incidence of adverse events (AEs), serious AEs and adjudicated cardiovascular events was 74.5, 7.1 and 0.9%, respectively, in patients receiving vildagliptin, and 81.1, 9.5 and 1.6%, respectively, in patients receiving Glimepiride. When metformin alone fails to maintain sufficient glycaemic control, the addition of vildagliptin provides comparable efficacy to that of Glimepiride after 52 weeks and displays a favourable AE profile, with no weight gain and a significant reduction in hypoglycaemia compared with Glimepiride. (Less)

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  • changes in prandial glucagon levels after a 2 year treatment with vildagliptin or Glimepiride in patients with type 2 diabetes inadequately controlled with metformin monotherapy
    Diabetes Care, 2010
    Co-Authors: Bo Ahrén, Sylvie Dejager, Eleuterio Ferrannini, Bernard Zinman, James E. Foley, David R Matthews, Vivian Fonseca
    Abstract:

    OBJECTIVE: To determine if the dipeptidyl peptidase-4 inhibitor vildagliptin more effectively inhibits glucagon levels than the sulfonylurea Glimepiride during a meal. RESEARCH DESIGN AND METHODS: Glucagon responses to a standard meal were measured at baseline and study end point (mean 1.8 years) in a trial evaluating add-on therapy to metformin with 50 mg vildagliptin b.i.d. compared with Glimepiride up to 6 mg q.d. in type 2 diabetes (baseline A1C 7.3 +/- 0.6%). RESULTS: A1C and prandial glucose area under the curve (AUC)(0-2 h) were reduced similarly in both groups, whereas prandial insulin AUC(0-2 h) increased to a greater extent by Glimepiride. Prandial glucagon AUC(0-2 h) (baseline 66.6 +/- 2.3 pmol . h(-1) . l(-1)) decreased by 3.4 +/- 1.6 pmol . h(-1) . l(-1) by vildagliptin (n = 137) and increased by 3.8 +/- 1.7 pmol . h(-1) . l(-1) by Glimepiride (n = 121). The between-group difference was 7.3 +/- 2.1 pmol . h(-1) . l(-1) (P < 0.001). CONCLUSIONS: Vildagliptin therapy but not Glimepiride improves postprandial alpha-cell function, which persists for at least 2 years.

  • fifty two week efficacy and safety of vildagliptin vs Glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy
    Diabetes Obesity and Metabolism, 2009
    Co-Authors: Eleuterio Ferrannini, D R Matthews, S Byiers, Q Shao, Vivian Fonseca, Bo Ahrén, Bernard Zinman, Sylvie Dejager
    Abstract:

    To examine the efficacy and safety of vildagliptin vs. Glimepiride as add-on therapy to metformin in patients with type 2 diabetes mellitus in a 52-week interim analysis of a large, randomized, double-blind, multicentre study. The primary objective was to demonstrate non-inferiority of vildagliptin vs. Glimepiride in glycosylated haemoglobin (HbA(1c)) reduction at week 52. Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) and receiving a stable dose of metformin (mean dose 1898 mg/day; mean duration of use 36 months) were randomized 1:1 to receive vildagliptin (50 mg twice daily, n = 1396) or Glimepiride (titrated up to 6 mg/day; mean dose 4.5 mg/day, n = 1393). Non-inferiority of vildagliptin was demonstrated (97.5% confidence interval 0.02%, 0.16%) with a mean (SE) change from baseline HbA(1c) (7.3% in both groups) to week 52 endpoint of -0.44% (0.02%) with vildagliptin and -0.53% (0.02%) with Glimepiride. Although a similar proportion of patients reached a target HbA(1c) level of < 7% with vildagliptin and Glimepiride (54.1 and 55.5%, respectively), a greater proportion of patients reached this target without hypoglycaemia in the vildagliptin group (50.9 vs. 44.3%; p < 0.01). Fasting plasma glucose (FPG) reductions were comparable between groups (mean [SE] -1.01 [0.06] mmol/l and -1.14 [0.06] mmol/l respectively). Vildagliptin significantly reduced body weight relative to Glimepiride (mean [SE] change from baseline -0.23 [0.11] kg; between-group difference -1.79 kg; p < 0.001) and resulted in a 10-fold lower incidence of hypoglycaemia than Glimepiride (1.7 vs. 16.2% of patients presenting at least one hypoglycaemic event; 39 vs. 554 hypoglycaemic events, p < 0.01). No severe hypoglycaemia occurred with vildagliptin compared with 10 episodes with Glimepiride (p < 0.01), and no patient in the vildagliptin group discontinued because of hypoglycaemia compared with 11 patients in the Glimepiride group. The incidence of adverse events (AEs), serious AEs and adjudicated cardiovascular events was 74.5, 7.1 and 0.9%, respectively, in patients receiving vildagliptin, and 81.1, 9.5 and 1.6%, respectively, in patients receiving Glimepiride. When metformin alone fails to maintain sufficient glycaemic control, the addition of vildagliptin provides comparable efficacy to that of Glimepiride after 52 weeks and displays a favourable AE profile, with no weight gain and a significant reduction in hypoglycaemia compared with Glimepiride. (Less)

  • fifty two week efficacy and safety of vildagliptin vs Glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy
    Diabetes Obesity and Metabolism, 2009
    Co-Authors: Eleuterio Ferrannini, D R Matthews, S Byiers, Q Shao, Vivian Fonseca, Bo Ahrén, Bernard Zinman, Sylvie Dejager
    Abstract:

    To examine the efficacy and safety of vildagliptin vs. Glimepiride as add-on therapy to metformin in patients with type 2 diabetes mellitus in a 52-week interim analysis of a large, randomized, double-blind, multicentre study. The primary objective was to demonstrate non-inferiority of vildagliptin vs. Glimepiride in glycosylated haemoglobin (HbA(1c)) reduction at week 52. Patients inadequately controlled on metformin monotherapy (HbA(1c) 6.5-8.5%) and receiving a stable dose of metformin (mean dose 1898 mg/day; mean duration of use 36 months) were randomized 1:1 to receive vildagliptin (50 mg twice daily, n = 1396) or Glimepiride (titrated up to 6 mg/day; mean dose 4.5 mg/day, n = 1393). Non-inferiority of vildagliptin was demonstrated (97.5% confidence interval 0.02%, 0.16%) with a mean (SE) change from baseline HbA(1c) (7.3% in both groups) to week 52 endpoint of -0.44% (0.02%) with vildagliptin and -0.53% (0.02%) with Glimepiride. Although a similar proportion of patients reached a target HbA(1c) level of < 7% with vildagliptin and Glimepiride (54.1 and 55.5%, respectively), a greater proportion of patients reached this target without hypoglycaemia in the vildagliptin group (50.9 vs. 44.3%; p < 0.01). Fasting plasma glucose (FPG) reductions were comparable between groups (mean [SE] -1.01 [0.06] mmol/l and -1.14 [0.06] mmol/l respectively). Vildagliptin significantly reduced body weight relative to Glimepiride (mean [SE] change from baseline -0.23 [0.11] kg; between-group difference -1.79 kg; p < 0.001) and resulted in a 10-fold lower incidence of hypoglycaemia than Glimepiride (1.7 vs. 16.2% of patients presenting at least one hypoglycaemic event; 39 vs. 554 hypoglycaemic events, p < 0.01). No severe hypoglycaemia occurred with vildagliptin compared with 10 episodes with Glimepiride (p < 0.01), and no patient in the vildagliptin group discontinued because of hypoglycaemia compared with 11 patients in the Glimepiride group. The incidence of adverse events (AEs), serious AEs and adjudicated cardiovascular events was 74.5, 7.1 and 0.9%, respectively, in patients receiving vildagliptin, and 81.1, 9.5 and 1.6%, respectively, in patients receiving Glimepiride. When metformin alone fails to maintain sufficient glycaemic control, the addition of vildagliptin provides comparable efficacy to that of Glimepiride after 52 weeks and displays a favourable AE profile, with no weight gain and a significant reduction in hypoglycaemia compared with Glimepiride. (Less)