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J Diabetes Investig. 2019 Nov 19. doi: 10.1111/jdi.13181. [Epub ahead of print]

Long-term (52-week) efficacy and safety of ipragliflozin add-on therapy to insulin in Japanese patients with type 1 diabetes mellitus: An uncontrolled, open-label extension of a phase 3 study.

Author information

1
Department of Medicine, Kawasaki Medical School, Okayama, Japan.
2
Japan/Asia Clinical Development, Astellas Pharma Inc, 2-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo, 103-8411, Japan.
3
Data Science, Astellas Pharma Inc, 2-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo, 103-8411, Japan.
4
Clinical Pharmacology and Exploratory Development, Astellas Pharma Inc, 2-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo, 103-8411, Japan.

Abstract

AIMS/INTRODUCTION:

To assess the long-term (52-week) efficacy and safety of ipragliflozin in insulin-treated Japanese patients with type 1 diabetes mellitus (T1DM) and inadequate glycemic control.

MATERIALS AND METHODS:

In this 28-week, open-label extension of a multicenter, randomized, placebo-controlled, 24-week phase 3 study, ipragliflozin recipients continued treatment (50 mg, once daily) and placebo recipients were switched to once-daily 50 mg ipragliflozin at the start of the extension period. The ipragliflozin dose could be increased to 100 mg if warranted. The primary endpoint was change in glycated hemoglobin (HbA1c); secondary endpoints were change in insulin dose and body weight. Safety outcomes were monitored as treatment-emergent adverse events (TEAEs).

RESULTS:

Fifty-three (placeboipragliflozin) and 108 (ipragliflozin) patients completed the open-label extension (treatment period 2), with 24 and 44 patients, respectively, receiving dose increases. From baseline to end of treatment, the overall mean change (standard deviation) in HbA1c was -0.33% (0.72) (-3.7 mmol/mol [7.9]), with changes in basal, bolus and total insulin doses of -3.76 (3.85), -2.51 (7.08) and -6.27 (8.16) IU, respectively. No serious drug-related TEAEs or deaths were reported. TEAEs leading to study discontinuation occurred in 0 and 3 (2.6%) patients in the placeboipragliflozin and ipragliflozin groups, respectively; all were considered drug-related. There were no cases of severe hypoglycemia or diabetic ketoacidosis and no safety concerns related to dose increase.

CONCLUSIONS:

Efficacy and safety of 50 mg, once-daily ipragliflozin in insulin-treated T1DM patients were confirmed in this long-term, open-label extension study. No safety concerns were attributed to a dose increase to 100 mg.

KEYWORDS:

Diabetes Mellitus; Insulin; Sodium-Glucose Transporter 2 Inhibitors; Type 1

PMID:
31743569
DOI:
10.1111/jdi.13181
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