Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin: Results of the GALIANT trial - A primary care, type 2 diabetes study

L. Blonde, Samuel Dagogo-Jack, M. A. Banerji, R. E. Pratley, A. Marcellari, R. Braceras, D. Purkayastha, M. Baron

Research output: Contribution to journalArticle

42 Citations (Scopus)

Abstract

Aim: To assess the efficacy and tolerability of vildagliptin compared with thiazolidinediones (TZDs) as an add on to metformin treatment in a primary care patient population with type 2 diabetes. Methods: This was a randomized, 12-week, open-label study comparing vildagliptin (100 mg, n = 1653) and TZD (agent and dose at the investigators' discretion, n = 825) add-on therapy in patients inadequately controlled [haemoglobin A1C (HbA1c): 7-10%] on a stable dose of metformin (≥1000 mg/day). The primary objective was to test non-inferiority of vildagliptin to TZDs for the difference in change in HbA1c from baseline [established if the upper limit of the two-sided 95% confidence intervals (CI) did not exceed 0.4%]. Results: Mean (± s.e.) change in HbA1c from baseline to study endpoint was -0.68 ± 0.02% in the vildagliptin group and -0.57 ± 0.03% in the TZD group. The difference between groups was -0.11% (95% CI: -0.17% and -0.04%), establishing the non-inferiority of vildagliptin (p = 0.001) after 3 months of treatment. Vildagliptin was non-inferior to TZDs for subgroups of race, age and body mass index. Body weight increased in the TZD group (0.33 ± 0.11 kg) and decreased in the vildagliptin group (mean: -0.58 ± 0.09 kg; p < 0.001 for difference). Adverse events occurred in similar proportions of patients in both groups (vildagliptin: 39.5% and TZD: 36.3%) Hypoglycaemia and abnormal changes in liver enzymes were uncommon. Conclusions: This short-term study suggests that vildagliptin is as effective as TZDs after 3-month treatment as an add-on to metformin in a primary care population that included diverse patient subgroups.

Original languageEnglish (US)
Pages (from-to)978-986
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume11
Issue number10
DOIs
StatePublished - Jan 1 2009

Fingerprint

Thiazolidinediones
Metformin
Type 2 Diabetes Mellitus
Primary Health Care
Hemoglobins
Therapeutics
Confidence Intervals
2,4-thiazolidinedione
vildagliptin
Hypoglycemia
Population
Body Mass Index
Body Weight
Research Personnel
Liver
Enzymes

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin : Results of the GALIANT trial - A primary care, type 2 diabetes study. / Blonde, L.; Dagogo-Jack, Samuel; Banerji, M. A.; Pratley, R. E.; Marcellari, A.; Braceras, R.; Purkayastha, D.; Baron, M.

In: Diabetes, Obesity and Metabolism, Vol. 11, No. 10, 01.01.2009, p. 978-986.

Research output: Contribution to journalArticle

@article{24e59831cd6c44379f127a8e5dfd9c60,
title = "Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin: Results of the GALIANT trial - A primary care, type 2 diabetes study",
abstract = "Aim: To assess the efficacy and tolerability of vildagliptin compared with thiazolidinediones (TZDs) as an add on to metformin treatment in a primary care patient population with type 2 diabetes. Methods: This was a randomized, 12-week, open-label study comparing vildagliptin (100 mg, n = 1653) and TZD (agent and dose at the investigators' discretion, n = 825) add-on therapy in patients inadequately controlled [haemoglobin A1C (HbA1c): 7-10{\%}] on a stable dose of metformin (≥1000 mg/day). The primary objective was to test non-inferiority of vildagliptin to TZDs for the difference in change in HbA1c from baseline [established if the upper limit of the two-sided 95{\%} confidence intervals (CI) did not exceed 0.4{\%}]. Results: Mean (± s.e.) change in HbA1c from baseline to study endpoint was -0.68 ± 0.02{\%} in the vildagliptin group and -0.57 ± 0.03{\%} in the TZD group. The difference between groups was -0.11{\%} (95{\%} CI: -0.17{\%} and -0.04{\%}), establishing the non-inferiority of vildagliptin (p = 0.001) after 3 months of treatment. Vildagliptin was non-inferior to TZDs for subgroups of race, age and body mass index. Body weight increased in the TZD group (0.33 ± 0.11 kg) and decreased in the vildagliptin group (mean: -0.58 ± 0.09 kg; p < 0.001 for difference). Adverse events occurred in similar proportions of patients in both groups (vildagliptin: 39.5{\%} and TZD: 36.3{\%}) Hypoglycaemia and abnormal changes in liver enzymes were uncommon. Conclusions: This short-term study suggests that vildagliptin is as effective as TZDs after 3-month treatment as an add-on to metformin in a primary care population that included diverse patient subgroups.",
author = "L. Blonde and Samuel Dagogo-Jack and Banerji, {M. A.} and Pratley, {R. E.} and A. Marcellari and R. Braceras and D. Purkayastha and M. Baron",
year = "2009",
month = "1",
day = "1",
doi = "10.1111/j.1463-1326.2009.01080.x",
language = "English (US)",
volume = "11",
pages = "978--986",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",
number = "10",

}

TY - JOUR

T1 - Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin

T2 - Results of the GALIANT trial - A primary care, type 2 diabetes study

AU - Blonde, L.

AU - Dagogo-Jack, Samuel

AU - Banerji, M. A.

AU - Pratley, R. E.

AU - Marcellari, A.

AU - Braceras, R.

AU - Purkayastha, D.

AU - Baron, M.

PY - 2009/1/1

Y1 - 2009/1/1

N2 - Aim: To assess the efficacy and tolerability of vildagliptin compared with thiazolidinediones (TZDs) as an add on to metformin treatment in a primary care patient population with type 2 diabetes. Methods: This was a randomized, 12-week, open-label study comparing vildagliptin (100 mg, n = 1653) and TZD (agent and dose at the investigators' discretion, n = 825) add-on therapy in patients inadequately controlled [haemoglobin A1C (HbA1c): 7-10%] on a stable dose of metformin (≥1000 mg/day). The primary objective was to test non-inferiority of vildagliptin to TZDs for the difference in change in HbA1c from baseline [established if the upper limit of the two-sided 95% confidence intervals (CI) did not exceed 0.4%]. Results: Mean (± s.e.) change in HbA1c from baseline to study endpoint was -0.68 ± 0.02% in the vildagliptin group and -0.57 ± 0.03% in the TZD group. The difference between groups was -0.11% (95% CI: -0.17% and -0.04%), establishing the non-inferiority of vildagliptin (p = 0.001) after 3 months of treatment. Vildagliptin was non-inferior to TZDs for subgroups of race, age and body mass index. Body weight increased in the TZD group (0.33 ± 0.11 kg) and decreased in the vildagliptin group (mean: -0.58 ± 0.09 kg; p < 0.001 for difference). Adverse events occurred in similar proportions of patients in both groups (vildagliptin: 39.5% and TZD: 36.3%) Hypoglycaemia and abnormal changes in liver enzymes were uncommon. Conclusions: This short-term study suggests that vildagliptin is as effective as TZDs after 3-month treatment as an add-on to metformin in a primary care population that included diverse patient subgroups.

AB - Aim: To assess the efficacy and tolerability of vildagliptin compared with thiazolidinediones (TZDs) as an add on to metformin treatment in a primary care patient population with type 2 diabetes. Methods: This was a randomized, 12-week, open-label study comparing vildagliptin (100 mg, n = 1653) and TZD (agent and dose at the investigators' discretion, n = 825) add-on therapy in patients inadequately controlled [haemoglobin A1C (HbA1c): 7-10%] on a stable dose of metformin (≥1000 mg/day). The primary objective was to test non-inferiority of vildagliptin to TZDs for the difference in change in HbA1c from baseline [established if the upper limit of the two-sided 95% confidence intervals (CI) did not exceed 0.4%]. Results: Mean (± s.e.) change in HbA1c from baseline to study endpoint was -0.68 ± 0.02% in the vildagliptin group and -0.57 ± 0.03% in the TZD group. The difference between groups was -0.11% (95% CI: -0.17% and -0.04%), establishing the non-inferiority of vildagliptin (p = 0.001) after 3 months of treatment. Vildagliptin was non-inferior to TZDs for subgroups of race, age and body mass index. Body weight increased in the TZD group (0.33 ± 0.11 kg) and decreased in the vildagliptin group (mean: -0.58 ± 0.09 kg; p < 0.001 for difference). Adverse events occurred in similar proportions of patients in both groups (vildagliptin: 39.5% and TZD: 36.3%) Hypoglycaemia and abnormal changes in liver enzymes were uncommon. Conclusions: This short-term study suggests that vildagliptin is as effective as TZDs after 3-month treatment as an add-on to metformin in a primary care population that included diverse patient subgroups.

UR - http://www.scopus.com/inward/record.url?scp=70349761649&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=70349761649&partnerID=8YFLogxK

U2 - 10.1111/j.1463-1326.2009.01080.x

DO - 10.1111/j.1463-1326.2009.01080.x

M3 - Article

C2 - 19614942

AN - SCOPUS:70349761649

VL - 11

SP - 978

EP - 986

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

IS - 10

ER -