Vildagliptin versus Placebo in Treatment of Type 2 Diabetes: A Meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 ZHAN Mei , WU Fengbo , HUANG Jing , TANG Yao

Dept. of Pharmacy, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

ZHAN Mei, Email: yaotangwch@yahoo.cn

Keywords：

Vildagliptin; Type 2 diabetes; Meta-analysis; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.20110178

Video：

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Objective 　To evaluate the efficacy and safety of vildagliptin vs. placebo for patients with type 2 diabetes.
Methods 　The following databases as The Cochrane Library (Issue 2, 2010), PubMed (1978 to September, 2010), EMbase (1974 to September, 2010), CNKI (1978 to September, 2010), VIP (1989 to September, 2010) and CBM (1978 to September, 2010) were searched to collect the randomized controlled trials (RCTs) of vildagliptin vs. placebo in treating type 2 diabetes. Two reviewers screened the trials according to the inclusion and exclusion criteria, extracted the data, assessed the quality in accordance with the Cochrane Collaboration, and conducted meta-analyses with RevMan 5.0 software.
Results 　A total of 13 studies were included. The results of meta-analyses showed that the vildagliptin given as monotherapy led to greater reduction in HbA1c compared with the placebo (MD= –0.76, 95%CI –0.94 to –0.58, P lt;0.000 01), but it was inferior to the placebo in losing weight (MD=0.68, 95%CI 0.29 to 1.07, P=0.000 6). When the vildagliptin was given as monotherapy, there was no statistical difference in the incidence of overall adverse events (AEs) (OR=1.00, 95%CI 0.83 to 1.21, P=0.98) and hypoglycaemia (OR=1.03, 95%CI 0.65 to 1.65, P=0.89). When the vildagliptin was combined with other oral antihyperglycemic drugs or insulin, it produced greater reduction in level of HbA1c (MD= –0.76, 95%CI –0.94 to –0.58, P lt;0.000 01), and there was no statistically significant difference between vildagliptin and placebo in weight loss (MD=0.40, 95%CI –0.25 to 1.05, P=0.23), AEs (OR=0.95, 95%CI 0.76 to 1.18, P=0.62) and hypoglycaemia (OR=1.11, 95%CI 0.49 to 2.53, P=0.80).
Conclusion 　The vildagliptin treatment for type 2 diabetes is effective and safe. A long-term study in large scale with high quality is required to confirm its long-term outcomes.

Citation： ZHAN Mei,WU Fengbo,HUANG Jing,TANG Yao. Vildagliptin versus Placebo in Treatment of Type 2 Diabetes: A Meta-analysis. Chinese Journal of Evidence-Based Medicine, 2011, 11(9): 1070-1077. doi: 10.7507/1672-2531.20110178 Copy

1.	1 Yang W, Lu J, Weng J, et al . Prevalence of diabetes among men and women in China. N Engl J Med , 2010, 362(12): 1090-1101.
2.	Ryden L, Standl E, Bartnik M, et al . Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J, 2007, 28(1): 88-136.
3.	Mari A, Sallas WM, He YL, et al . Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with type 2 diabetes. J Clin Endocrinol Metab , 2005, 90(8): 4888-4894.
4.	Higgins J, Green S. Cochrane handbook for systematic reviews of interventions version 5.0. 2 [updated September 2009]. The Cochrane Collaboration. 2009.
5.	Ahrén B, Gomis R, Standl E, et al . Twelve- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 in metformin-treated patients with type 2 diabetes. Diabetes Care , 2004(12): 2874-2880.
6.	Bosi E, Camisasca RP, Collober C, et al . Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care , 2007, 30(4): 890-895.
7.	Dejager S, Razac S, Foley JE, et al . Vildagliptin in drug-naive patients with type 2 diabetes: A 24-week, double-blind, randomized, placebo-controlled, multiple-dose study. Hormone and Metabolic Research , 2007, 39(3): 218-223.
8.	Fonseca V, Schweizer A, Albrecht D, et al . Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes. Diabetologia , 2007, 50(6): 1148-1155.
9.	Garber AJ, Schweizer A, Baron MA, et al . Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: A randomized, placebo-controlled study. Diabetes, Obesity and Metabolism , 2007, 9(2): 166-174.
10.	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, Obesity and Metabolism , 2008, 10(11): 1047-1056.
11.	Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Hormone and metabolic research , 2009(5): 368-373.
12.	Kikuchi M, Abe N, Kato M, et al . Vildagliptin dose-dependently improves glycemic control in Japanese patients with type 2 diabetes mellitus. Diabetes research and clinical practice , 2009, 83(2): 233-240.
13.	Kikuchi M, Haneda M, Koya D, et al . Efficacy and tolerability of vildagliptin as an add-on to glimepiride in Japanese patients with Type 2 diabetes mellitus. Diabetes Res Clin Pract , 2010, 89(3): 216-223.
14.	Pi-Sunyer FX, Schweizer A, Mills D, et al . Efficacy and tolerability of vildagliptin monotherapy in drug-naïve patients with type 2 diabetes. Diabetes research and clinical practice , 2007, (1): 132-138.
15.	Pratley RE, Jauffret-Kamel S, Galbreath E, Holmes D. Twelve-week monotherapy with the DPP-4 inhibitor vildagliptin improves glycemic control in subjects with type 2 diabetes. Hormone and Metabolic Research , 2006, 38(6): 423-428.
16.	Ristic S, Byiers S, Foley J, Holmes D. Improved glycaemic control with dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes: Vildagliptin (LAF237) dose response. Diabetes, Obesity and Metabolism , 2005, 7(6): 692-698.
17.	Scherbaum WA, Schweizer A, Mari A, et al . Efficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemia. Diabetes, Obesity and Metabolism , 2008, 10(8): 675-682.

1. 1 Yang W, Lu J, Weng J, et al . Prevalence of diabetes among men and women in China. N Engl J Med , 2010, 362(12): 1090-1101.
2. Ryden L, Standl E, Bartnik M, et al . Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J, 2007, 28(1): 88-136.
3. Mari A, Sallas WM, He YL, et al . Vildagliptin, a dipeptidyl peptidase-IV inhibitor, improves model-assessed beta-cell function in patients with type 2 diabetes. J Clin Endocrinol Metab , 2005, 90(8): 4888-4894.
4. Higgins J, Green S. Cochrane handbook for systematic reviews of interventions version 5.0. 2 [updated September 2009]. The Cochrane Collaboration. 2009.
5. Ahrén B, Gomis R, Standl E, et al . Twelve- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 in metformin-treated patients with type 2 diabetes. Diabetes Care , 2004(12): 2874-2880.
6. Bosi E, Camisasca RP, Collober C, et al . Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care , 2007, 30(4): 890-895.
7. Dejager S, Razac S, Foley JE, et al . Vildagliptin in drug-naive patients with type 2 diabetes: A 24-week, double-blind, randomized, placebo-controlled, multiple-dose study. Hormone and Metabolic Research , 2007, 39(3): 218-223.
8. Fonseca V, Schweizer A, Albrecht D, et al . Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes. Diabetologia , 2007, 50(6): 1148-1155.
9. Garber AJ, Schweizer A, Baron MA, et al . Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: A randomized, placebo-controlled study. Diabetes, Obesity and Metabolism , 2007, 9(2): 166-174.
10. 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, Obesity and Metabolism , 2008, 10(11): 1047-1056.
11. Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Hormone and metabolic research , 2009(5): 368-373.
12. Kikuchi M, Abe N, Kato M, et al . Vildagliptin dose-dependently improves glycemic control in Japanese patients with type 2 diabetes mellitus. Diabetes research and clinical practice , 2009, 83(2): 233-240.
13. Kikuchi M, Haneda M, Koya D, et al . Efficacy and tolerability of vildagliptin as an add-on to glimepiride in Japanese patients with Type 2 diabetes mellitus. Diabetes Res Clin Pract , 2010, 89(3): 216-223.
14. Pi-Sunyer FX, Schweizer A, Mills D, et al . Efficacy and tolerability of vildagliptin monotherapy in drug-naïve patients with type 2 diabetes. Diabetes research and clinical practice , 2007, (1): 132-138.
15. Pratley RE, Jauffret-Kamel S, Galbreath E, Holmes D. Twelve-week monotherapy with the DPP-4 inhibitor vildagliptin improves glycemic control in subjects with type 2 diabetes. Hormone and Metabolic Research , 2006, 38(6): 423-428.
16. Ristic S, Byiers S, Foley J, Holmes D. Improved glycaemic control with dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes: Vildagliptin (LAF237) dose response. Diabetes, Obesity and Metabolism , 2005, 7(6): 692-698.
17. Scherbaum WA, Schweizer A, Mari A, et al . Efficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemia. Diabetes, Obesity and Metabolism , 2008, 10(8): 675-682.

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Vildagliptin versus Placebo in Treatment of Type 2 Diabetes: A Meta-analysis

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