Efficacy and safety of ipragliflozin as an add-on therapy to sitagliptin and metformin in Korean patients with inadequately controlled type 2 diabetes mellitus: A randomized controlled trial

Kyung Ah Han, Suk Chon, Choon Hee Chung, Soo Lim, Kwan Woo Lee, Sei-Hyun Baik, Chang Hee Jung, Dong Sun Kim, Kyong Soo Park, Kun Ho Yoon, In Kyu Lee, Bong Soo Cha, Taishi Sakatani, Sumi Park, Moon Kyu Lee

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Abstract

Aim: To evaluate the efficacy and safety of ipragliflozin vs placebo as add-on therapy to metformin and sitagliptin in Korean patients with type 2 diabetes mellitus (T2DM). Methods: This double-blind, placebo-controlled, multi-centre, phase III study was conducted in Korea in 2015 to 2017. Patients were randomized to receive either ipragliflozin 50 mg/day or placebo once daily for 24 weeks in addition to metformin and sitagliptin. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to end of treatment (EOT). Results: In total, 143 patients were randomized and 139 were included in efficacy analyses (ipragliflozin: 73, placebo: 66). Baseline mean (SD) HbA1c levels were 7.90 (0.69)% for ipragliflozin add-on and 7.92 (0.79)% for placebo. The corresponding mean (SD) changes from baseline to EOT were −0.79 (0.59)% and 0.03 (0.84)%, respectively, in favour of ipragliflozin (adjusted mean difference −0.83% [95% CI −1.07 to −0.59]; P <.0001). More ipragliflozin-treated patients than placebo-treated patients achieved HbA1c target levels of <7.0% (44.4% vs 12.1%) and < 6.5% (12.5% vs 1.5%) at EOT (P <.05 for both). Fasting plasma glucose, fasting serum insulin, body weight and homeostatic model assessment of insulin resistance decreased significantly at EOT, in favour of ipragliflozin (adjusted mean difference −1.64 mmol/L, −1.50 μU/mL, −1.72 kg, and −0.99, respectively; P <.05 for all). Adverse event rates were similar between groups (ipragliflozin: 51.4%; placebo: 50.0%). No previously unreported safety concerns were noted. Conclusions: Ipragliflozin as add-on to metformin and sitagliptin significantly improved glycaemic variables and demonstrated a good safety profile in Korean patients with inadequately controlled T2DM.

Original languageEnglish
Pages (from-to)2408-2415
Number of pages8
JournalDiabetes, Obesity and Metabolism
Volume20
Issue number10
DOIs
Publication statusPublished - 2018 Oct 1

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Metformin
Type 2 Diabetes Mellitus
Randomized Controlled Trials
Safety
Placebos
Therapeutics
Fasting
Sitagliptin Phosphate
ipragliflozin
Glycosylated Hemoglobin A
Korea
Double-Blind Method
Insulin Resistance
Body Weight
Insulin
Glucose

Keywords

  • DPP-4 inhibitor
  • ipragliflozin
  • Korean
  • randomized controlled trial
  • SGLT2 inhibitor
  • type 2 diabetes mellitus

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Efficacy and safety of ipragliflozin as an add-on therapy to sitagliptin and metformin in Korean patients with inadequately controlled type 2 diabetes mellitus : A randomized controlled trial. / Han, Kyung Ah; Chon, Suk; Chung, Choon Hee; Lim, Soo; Lee, Kwan Woo; Baik, Sei-Hyun; Jung, Chang Hee; Kim, Dong Sun; Park, Kyong Soo; Yoon, Kun Ho; Lee, In Kyu; Cha, Bong Soo; Sakatani, Taishi; Park, Sumi; Lee, Moon Kyu.

In: Diabetes, Obesity and Metabolism, Vol. 20, No. 10, 01.10.2018, p. 2408-2415.

Research output: Contribution to journalArticle

Han, KA, Chon, S, Chung, CH, Lim, S, Lee, KW, Baik, S-H, Jung, CH, Kim, DS, Park, KS, Yoon, KH, Lee, IK, Cha, BS, Sakatani, T, Park, S & Lee, MK 2018, 'Efficacy and safety of ipragliflozin as an add-on therapy to sitagliptin and metformin in Korean patients with inadequately controlled type 2 diabetes mellitus: A randomized controlled trial', Diabetes, Obesity and Metabolism, vol. 20, no. 10, pp. 2408-2415. https://doi.org/10.1111/dom.13394
Han, Kyung Ah ; Chon, Suk ; Chung, Choon Hee ; Lim, Soo ; Lee, Kwan Woo ; Baik, Sei-Hyun ; Jung, Chang Hee ; Kim, Dong Sun ; Park, Kyong Soo ; Yoon, Kun Ho ; Lee, In Kyu ; Cha, Bong Soo ; Sakatani, Taishi ; Park, Sumi ; Lee, Moon Kyu. / Efficacy and safety of ipragliflozin as an add-on therapy to sitagliptin and metformin in Korean patients with inadequately controlled type 2 diabetes mellitus : A randomized controlled trial. In: Diabetes, Obesity and Metabolism. 2018 ; Vol. 20, No. 10. pp. 2408-2415.
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abstract = "Aim: To evaluate the efficacy and safety of ipragliflozin vs placebo as add-on therapy to metformin and sitagliptin in Korean patients with type 2 diabetes mellitus (T2DM). Methods: This double-blind, placebo-controlled, multi-centre, phase III study was conducted in Korea in 2015 to 2017. Patients were randomized to receive either ipragliflozin 50 mg/day or placebo once daily for 24 weeks in addition to metformin and sitagliptin. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to end of treatment (EOT). Results: In total, 143 patients were randomized and 139 were included in efficacy analyses (ipragliflozin: 73, placebo: 66). Baseline mean (SD) HbA1c levels were 7.90 (0.69){\%} for ipragliflozin add-on and 7.92 (0.79){\%} for placebo. The corresponding mean (SD) changes from baseline to EOT were −0.79 (0.59){\%} and 0.03 (0.84){\%}, respectively, in favour of ipragliflozin (adjusted mean difference −0.83{\%} [95{\%} CI −1.07 to −0.59]; P <.0001). More ipragliflozin-treated patients than placebo-treated patients achieved HbA1c target levels of <7.0{\%} (44.4{\%} vs 12.1{\%}) and < 6.5{\%} (12.5{\%} vs 1.5{\%}) at EOT (P <.05 for both). Fasting plasma glucose, fasting serum insulin, body weight and homeostatic model assessment of insulin resistance decreased significantly at EOT, in favour of ipragliflozin (adjusted mean difference −1.64 mmol/L, −1.50 μU/mL, −1.72 kg, and −0.99, respectively; P <.05 for all). Adverse event rates were similar between groups (ipragliflozin: 51.4{\%}; placebo: 50.0{\%}). No previously unreported safety concerns were noted. Conclusions: Ipragliflozin as add-on to metformin and sitagliptin significantly improved glycaemic variables and demonstrated a good safety profile in Korean patients with inadequately controlled T2DM.",
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T1 - Efficacy and safety of ipragliflozin as an add-on therapy to sitagliptin and metformin in Korean patients with inadequately controlled type 2 diabetes mellitus

T2 - A randomized controlled trial

AU - Han, Kyung Ah

AU - Chon, Suk

AU - Chung, Choon Hee

AU - Lim, Soo

AU - Lee, Kwan Woo

AU - Baik, Sei-Hyun

AU - Jung, Chang Hee

AU - Kim, Dong Sun

AU - Park, Kyong Soo

AU - Yoon, Kun Ho

AU - Lee, In Kyu

AU - Cha, Bong Soo

AU - Sakatani, Taishi

AU - Park, Sumi

AU - Lee, Moon Kyu

PY - 2018/10/1

Y1 - 2018/10/1

N2 - Aim: To evaluate the efficacy and safety of ipragliflozin vs placebo as add-on therapy to metformin and sitagliptin in Korean patients with type 2 diabetes mellitus (T2DM). Methods: This double-blind, placebo-controlled, multi-centre, phase III study was conducted in Korea in 2015 to 2017. Patients were randomized to receive either ipragliflozin 50 mg/day or placebo once daily for 24 weeks in addition to metformin and sitagliptin. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to end of treatment (EOT). Results: In total, 143 patients were randomized and 139 were included in efficacy analyses (ipragliflozin: 73, placebo: 66). Baseline mean (SD) HbA1c levels were 7.90 (0.69)% for ipragliflozin add-on and 7.92 (0.79)% for placebo. The corresponding mean (SD) changes from baseline to EOT were −0.79 (0.59)% and 0.03 (0.84)%, respectively, in favour of ipragliflozin (adjusted mean difference −0.83% [95% CI −1.07 to −0.59]; P <.0001). More ipragliflozin-treated patients than placebo-treated patients achieved HbA1c target levels of <7.0% (44.4% vs 12.1%) and < 6.5% (12.5% vs 1.5%) at EOT (P <.05 for both). Fasting plasma glucose, fasting serum insulin, body weight and homeostatic model assessment of insulin resistance decreased significantly at EOT, in favour of ipragliflozin (adjusted mean difference −1.64 mmol/L, −1.50 μU/mL, −1.72 kg, and −0.99, respectively; P <.05 for all). Adverse event rates were similar between groups (ipragliflozin: 51.4%; placebo: 50.0%). No previously unreported safety concerns were noted. Conclusions: Ipragliflozin as add-on to metformin and sitagliptin significantly improved glycaemic variables and demonstrated a good safety profile in Korean patients with inadequately controlled T2DM.

AB - Aim: To evaluate the efficacy and safety of ipragliflozin vs placebo as add-on therapy to metformin and sitagliptin in Korean patients with type 2 diabetes mellitus (T2DM). Methods: This double-blind, placebo-controlled, multi-centre, phase III study was conducted in Korea in 2015 to 2017. Patients were randomized to receive either ipragliflozin 50 mg/day or placebo once daily for 24 weeks in addition to metformin and sitagliptin. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to end of treatment (EOT). Results: In total, 143 patients were randomized and 139 were included in efficacy analyses (ipragliflozin: 73, placebo: 66). Baseline mean (SD) HbA1c levels were 7.90 (0.69)% for ipragliflozin add-on and 7.92 (0.79)% for placebo. The corresponding mean (SD) changes from baseline to EOT were −0.79 (0.59)% and 0.03 (0.84)%, respectively, in favour of ipragliflozin (adjusted mean difference −0.83% [95% CI −1.07 to −0.59]; P <.0001). More ipragliflozin-treated patients than placebo-treated patients achieved HbA1c target levels of <7.0% (44.4% vs 12.1%) and < 6.5% (12.5% vs 1.5%) at EOT (P <.05 for both). Fasting plasma glucose, fasting serum insulin, body weight and homeostatic model assessment of insulin resistance decreased significantly at EOT, in favour of ipragliflozin (adjusted mean difference −1.64 mmol/L, −1.50 μU/mL, −1.72 kg, and −0.99, respectively; P <.05 for all). Adverse event rates were similar between groups (ipragliflozin: 51.4%; placebo: 50.0%). No previously unreported safety concerns were noted. Conclusions: Ipragliflozin as add-on to metformin and sitagliptin significantly improved glycaemic variables and demonstrated a good safety profile in Korean patients with inadequately controlled T2DM.

KW - DPP-4 inhibitor

KW - ipragliflozin

KW - Korean

KW - randomized controlled trial

KW - SGLT2 inhibitor

KW - type 2 diabetes mellitus

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