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Diabetes Obes Metab. 2018 Oct;20(10):2408-2415. doi: 10.1111/dom.13394. Epub 2018 Jul 16.

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.

Author information

1
Nowon Eulji Medical Center, Eulji University, Seoul, Korea.
2
Kyung Hee University Hospital, Seoul, Korea.
3
Yonsei University Wonju Severance Christian Hospital, Gangwon, Korea.
4
Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, Korea.
5
Ajou University Hospital, Suwon-si, Korea.
6
Korea University Guro Hospital, Seoul, Korea.
7
Department of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
8
Department of Endocrinology and Metabolism, Hanyang University Hospital, Seoul, Korea.
9
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
10
Department of Endocrinology and Metabolism, Seoul St. Mary's Hospital, Catholic University Medical College, Seoul, Korea.
11
Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea.
12
Department of Internal Medicine, Yonsei University Severance Hospital, Seoul, Korea.
13
Biostatistics Group, Japan-Asia Data Science, Development, Astellas Pharma Inc., Tokyo, Japan.
14
Clinical Research Team, Development Department, Astellas Pharma Korea, Inc., Seoul, Korea.
15
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

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.

KEYWORDS:

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

PMID:
29862619
PMCID:
PMC6175352
DOI:
10.1111/dom.13394
[Indexed for MEDLINE]
Free PMC Article

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