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Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea.
Diabetes Obes Metab. 2008 Nov; 10(11):1047-56.DO

Abstract

AIM

To compare the efficacy and tolerability of vildagliptin vs. placebo in patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled [haemoglobin A(1c) (HbA(1c)) 7.5 to 11%] with prior sulphonylurea (SU) monotherapy.

METHODS

This 24-week, multicentre, randomized, double-blind, placebo-controlled study assessed the effects of the dipeptidyl peptidase-4 inhibitor vildagliptin (50 mg given once or twice daily) vs. placebo added to glimepiride (4 mg once daily) in 515 patients with T2DM. Adjusted mean changes from baseline to end-point (AMDelta) in HbA(1c), fasting plasma glucose, fasting lipids and body weight were compared by analysis of covariance.

RESULTS

The between-group difference (vildagliptin - placebo) in AMDelta HbA(1c) was -0.6 +/- 0.1% in patients receiving vildagliptin 50 mg daily and -0.7 +/- 0.1% in those receiving 100 mg daily (p < 0.001 vs. placebo for both). Greater efficacy was seen in patients > or =65 years of age (-0.7 +/- 0.1% and -0.8 +/- 0.2% for 50 and 100 mg daily respectively) and in patients with baseline HbA(1c) > 9% (Delta = -1.0 +/- 0.2% and -0.9 +/- 0.2% for 50 and 100 mg daily respectively). Relative to placebo, patients receiving vildagliptin also had improvements in beta-cell function and postprandial glucose, with small changes in fasting lipids and body weight. The incidences of adverse events (AEs) (67.1, 66.3 and 64.2%) and serious AEs (2.9, 2.4 and 5.1%) were similar in patients receiving 50 mg vildagliptin, 100 mg vildagliptin or placebo respectively. The incidence of hypoglycaemic events was low but slightly higher in the group receiving vildagliptin 100 mg (3.6%) than in the group receiving vildagliptin 50 mg (1.2%) or placebo (0.6%).

CONCLUSIONS

In patients with T2DM inadequately controlled with prior SU monotherapy, addition of vildagliptin (50 or 100 mg daily) to glimepiride (4 mg once daily) improves glycaemic control and is well tolerated. Addition of vildagliptin 50 mg daily to SU monotherapy may be a particularly attractive therapy in elderly patients.

Authors+Show Affiliations

Baylor College of Medicine, Houston, TX, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18284434

Citation

Garber, A J., et al. "Effects of Vildagliptin On Glucose Control in Patients With Type 2 Diabetes Inadequately Controlled With a Sulphonylurea." Diabetes, Obesity & Metabolism, vol. 10, no. 11, 2008, pp. 1047-56.
Garber AJ, Foley JE, Banerji MA, et al. Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. Diabetes Obes Metab. 2008;10(11):1047-56.
Garber, A. J., Foley, J. E., Banerji, M. A., Ebeling, P., Gudbjörnsdottir, S., Camisasca, R. P., Couturier, A., & Baron, M. A. (2008). Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. Diabetes, Obesity & Metabolism, 10(11), 1047-56. https://doi.org/10.1111/j.1463-1326.2008.00859.x
Garber AJ, et al. Effects of Vildagliptin On Glucose Control in Patients With Type 2 Diabetes Inadequately Controlled With a Sulphonylurea. Diabetes Obes Metab. 2008;10(11):1047-56. PubMed PMID: 18284434.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. AU - Garber,A J, AU - Foley,J E, AU - Banerji,M A, AU - Ebeling,P, AU - Gudbjörnsdottir,S, AU - Camisasca,R-P, AU - Couturier,A, AU - Baron,M A, Y1 - 2008/02/18/ PY - 2008/2/21/pubmed PY - 2009/8/21/medline PY - 2008/2/21/entrez SP - 1047 EP - 56 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 10 IS - 11 N2 - AIM: To compare the efficacy and tolerability of vildagliptin vs. placebo in patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled [haemoglobin A(1c) (HbA(1c)) 7.5 to 11%] with prior sulphonylurea (SU) monotherapy. METHODS: This 24-week, multicentre, randomized, double-blind, placebo-controlled study assessed the effects of the dipeptidyl peptidase-4 inhibitor vildagliptin (50 mg given once or twice daily) vs. placebo added to glimepiride (4 mg once daily) in 515 patients with T2DM. Adjusted mean changes from baseline to end-point (AMDelta) in HbA(1c), fasting plasma glucose, fasting lipids and body weight were compared by analysis of covariance. RESULTS: The between-group difference (vildagliptin - placebo) in AMDelta HbA(1c) was -0.6 +/- 0.1% in patients receiving vildagliptin 50 mg daily and -0.7 +/- 0.1% in those receiving 100 mg daily (p < 0.001 vs. placebo for both). Greater efficacy was seen in patients > or =65 years of age (-0.7 +/- 0.1% and -0.8 +/- 0.2% for 50 and 100 mg daily respectively) and in patients with baseline HbA(1c) > 9% (Delta = -1.0 +/- 0.2% and -0.9 +/- 0.2% for 50 and 100 mg daily respectively). Relative to placebo, patients receiving vildagliptin also had improvements in beta-cell function and postprandial glucose, with small changes in fasting lipids and body weight. The incidences of adverse events (AEs) (67.1, 66.3 and 64.2%) and serious AEs (2.9, 2.4 and 5.1%) were similar in patients receiving 50 mg vildagliptin, 100 mg vildagliptin or placebo respectively. The incidence of hypoglycaemic events was low but slightly higher in the group receiving vildagliptin 100 mg (3.6%) than in the group receiving vildagliptin 50 mg (1.2%) or placebo (0.6%). CONCLUSIONS: In patients with T2DM inadequately controlled with prior SU monotherapy, addition of vildagliptin (50 or 100 mg daily) to glimepiride (4 mg once daily) improves glycaemic control and is well tolerated. Addition of vildagliptin 50 mg daily to SU monotherapy may be a particularly attractive therapy in elderly patients. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/18284434/Effects_of_vildagliptin_on_glucose_control_in_patients_with_type_2_diabetes_inadequately_controlled_with_a_sulphonylurea_ L2 - https://doi.org/10.1111/j.1463-1326.2008.00859.x DB - PRIME DP - Unbound Medicine ER -