Comparison of vildagliptin as an add-on therapy and sulfonylurea dose-increasing therapy in patients with inadequately controlled type 2 diabetes using metformin and sulfonylurea (VISUAL study): A randomized trial

A. Ram Hong, Jeun Lee, Eu Jeong Ku, Yul Hwangbo, Kyung Min Kim, Jae Hoon Moon, Sung Hee Choi, Hak Chul Jang, Soo Lim

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10 Citations (Scopus)

Abstract

The aim of present study is to compare the efficacy and safety of adding vildagliptin with sulfonylurea dose-increasing as an active comparator in patients who had inadequately controlled type 2 diabetes mellitus (T2DM) using metformin plus sulfonylurea in real clinical practice. Patients using metformin plus sulfonylurea were assigned to either vildagliptin add-on (50mg twice a day, n=172) or sulfonylurea dose-increasing by 50% (n=172) treatment groups. The primary endpoint was a change in HbA1c after 24 weeks. The secondary endpoints were patients achieving HbA1c≤7.0% (53mmol/mol) and changes in the fasting plasma glucose (FPG), 2-h postprandial glucose (2pp), lipid profiles, and urine albumin-to-creatinine ratio. Body weight and hypoglycemia were also investigated. The mean HbA1c at baseline was 8.6% (70mmol/mol) in both groups. At week 24, the adjusted mean HbA1c levels decreased by -1.19% (-13.09mmol/mol) with vildagliptin add-on and -0.46% (-5.06mmol/mol) with sulfonylurea (P<0.001). Significantly more vildagliptin add-on patients achieved HbA1c≤7.0% (53mmol/mol) than did sulfonylurea patients (40.1% vs. 7.9%; P<0.001). Greater reductions in FPG and 2pp were observed with vildagliptin add-on than with sulfonylurea (P<0.001). The vildagliptin add-on group exhibited no clinically relevant weight gain and had a lower incidence of hypoglycemia compared with the sulfonylurea group. Vildagliptin add-on therapy might be a suitable option for patients with T2DM that is controlled inadequately by metformin and sulfonylurea, based on its greater glucose control and better safety profile (ClinicalTrial.gov: NCT01099137).

Original languageEnglish
Pages (from-to)141-148
Number of pages8
JournalDiabetes Research and Clinical Practice
Volume109
Issue number1
DOIs
StatePublished - 1 Jul 2015

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Metformin
Type 2 Diabetes Mellitus
Glucose
Hypoglycemia
Therapeutics
Fasting
Safety
vildagliptin
Weight Gain
Albumins
Creatinine
Body Weight
Urine
Lipids
Incidence

Keywords

  • Clinical trial
  • Hypoglycemia
  • Sulfonylurea
  • Vildagliptin

Cite this

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title = "Comparison of vildagliptin as an add-on therapy and sulfonylurea dose-increasing therapy in patients with inadequately controlled type 2 diabetes using metformin and sulfonylurea (VISUAL study): A randomized trial",
abstract = "The aim of present study is to compare the efficacy and safety of adding vildagliptin with sulfonylurea dose-increasing as an active comparator in patients who had inadequately controlled type 2 diabetes mellitus (T2DM) using metformin plus sulfonylurea in real clinical practice. Patients using metformin plus sulfonylurea were assigned to either vildagliptin add-on (50mg twice a day, n=172) or sulfonylurea dose-increasing by 50{\%} (n=172) treatment groups. The primary endpoint was a change in HbA1c after 24 weeks. The secondary endpoints were patients achieving HbA1c≤7.0{\%} (53mmol/mol) and changes in the fasting plasma glucose (FPG), 2-h postprandial glucose (2pp), lipid profiles, and urine albumin-to-creatinine ratio. Body weight and hypoglycemia were also investigated. The mean HbA1c at baseline was 8.6{\%} (70mmol/mol) in both groups. At week 24, the adjusted mean HbA1c levels decreased by -1.19{\%} (-13.09mmol/mol) with vildagliptin add-on and -0.46{\%} (-5.06mmol/mol) with sulfonylurea (P<0.001). Significantly more vildagliptin add-on patients achieved HbA1c≤7.0{\%} (53mmol/mol) than did sulfonylurea patients (40.1{\%} vs. 7.9{\%}; P<0.001). Greater reductions in FPG and 2pp were observed with vildagliptin add-on than with sulfonylurea (P<0.001). The vildagliptin add-on group exhibited no clinically relevant weight gain and had a lower incidence of hypoglycemia compared with the sulfonylurea group. Vildagliptin add-on therapy might be a suitable option for patients with T2DM that is controlled inadequately by metformin and sulfonylurea, based on its greater glucose control and better safety profile (ClinicalTrial.gov: NCT01099137).",
keywords = "Clinical trial, Hypoglycemia, Sulfonylurea, Vildagliptin",
author = "Hong, {A. Ram} and Jeun Lee and Ku, {Eu Jeong} and Yul Hwangbo and Kim, {Kyung Min} and Moon, {Jae Hoon} and Choi, {Sung Hee} and Jang, {Hak Chul} and Soo Lim",
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TY - JOUR

T1 - Comparison of vildagliptin as an add-on therapy and sulfonylurea dose-increasing therapy in patients with inadequately controlled type 2 diabetes using metformin and sulfonylurea (VISUAL study)

T2 - A randomized trial

AU - Hong, A. Ram

AU - Lee, Jeun

AU - Ku, Eu Jeong

AU - Hwangbo, Yul

AU - Kim, Kyung Min

AU - Moon, Jae Hoon

AU - Choi, Sung Hee

AU - Jang, Hak Chul

AU - Lim, Soo

PY - 2015/7/1

Y1 - 2015/7/1

N2 - The aim of present study is to compare the efficacy and safety of adding vildagliptin with sulfonylurea dose-increasing as an active comparator in patients who had inadequately controlled type 2 diabetes mellitus (T2DM) using metformin plus sulfonylurea in real clinical practice. Patients using metformin plus sulfonylurea were assigned to either vildagliptin add-on (50mg twice a day, n=172) or sulfonylurea dose-increasing by 50% (n=172) treatment groups. The primary endpoint was a change in HbA1c after 24 weeks. The secondary endpoints were patients achieving HbA1c≤7.0% (53mmol/mol) and changes in the fasting plasma glucose (FPG), 2-h postprandial glucose (2pp), lipid profiles, and urine albumin-to-creatinine ratio. Body weight and hypoglycemia were also investigated. The mean HbA1c at baseline was 8.6% (70mmol/mol) in both groups. At week 24, the adjusted mean HbA1c levels decreased by -1.19% (-13.09mmol/mol) with vildagliptin add-on and -0.46% (-5.06mmol/mol) with sulfonylurea (P<0.001). Significantly more vildagliptin add-on patients achieved HbA1c≤7.0% (53mmol/mol) than did sulfonylurea patients (40.1% vs. 7.9%; P<0.001). Greater reductions in FPG and 2pp were observed with vildagliptin add-on than with sulfonylurea (P<0.001). The vildagliptin add-on group exhibited no clinically relevant weight gain and had a lower incidence of hypoglycemia compared with the sulfonylurea group. Vildagliptin add-on therapy might be a suitable option for patients with T2DM that is controlled inadequately by metformin and sulfonylurea, based on its greater glucose control and better safety profile (ClinicalTrial.gov: NCT01099137).

AB - The aim of present study is to compare the efficacy and safety of adding vildagliptin with sulfonylurea dose-increasing as an active comparator in patients who had inadequately controlled type 2 diabetes mellitus (T2DM) using metformin plus sulfonylurea in real clinical practice. Patients using metformin plus sulfonylurea were assigned to either vildagliptin add-on (50mg twice a day, n=172) or sulfonylurea dose-increasing by 50% (n=172) treatment groups. The primary endpoint was a change in HbA1c after 24 weeks. The secondary endpoints were patients achieving HbA1c≤7.0% (53mmol/mol) and changes in the fasting plasma glucose (FPG), 2-h postprandial glucose (2pp), lipid profiles, and urine albumin-to-creatinine ratio. Body weight and hypoglycemia were also investigated. The mean HbA1c at baseline was 8.6% (70mmol/mol) in both groups. At week 24, the adjusted mean HbA1c levels decreased by -1.19% (-13.09mmol/mol) with vildagliptin add-on and -0.46% (-5.06mmol/mol) with sulfonylurea (P<0.001). Significantly more vildagliptin add-on patients achieved HbA1c≤7.0% (53mmol/mol) than did sulfonylurea patients (40.1% vs. 7.9%; P<0.001). Greater reductions in FPG and 2pp were observed with vildagliptin add-on than with sulfonylurea (P<0.001). The vildagliptin add-on group exhibited no clinically relevant weight gain and had a lower incidence of hypoglycemia compared with the sulfonylurea group. Vildagliptin add-on therapy might be a suitable option for patients with T2DM that is controlled inadequately by metformin and sulfonylurea, based on its greater glucose control and better safety profile (ClinicalTrial.gov: NCT01099137).

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KW - Hypoglycemia

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